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IBA JOB BOARD
OPPORTUNITIES ON THE HORIZON
We pledge to our members that we will keep our Job Board updated regularly.
Anyone can post a job/internship opportunity on this board.
It is free. Email
iba.webmail@gmail.com.
Please send posting with the following format
1. Position Title
2. Company
3. Contact name and phone number
4. Contact email
5. Job description
6. Qualifications
RECENT JOB POSTINGS
Quality Systems Director - [ CLICK HERE ]
Microbiologist - [ CLICK HERE ]
Quality Systems Manager and Regulatory Affairs - [ CLICK HERE ]
Contracts Specialist / Project Manager - [ CLICK HERE ]
Quality Assurance Technician I - [ CLICK HERE ]
Engineering Internship -Material Science or Mechanical Engineering - [ CLICK HERE ]
Manager, Post-Market Surveillance - [ CLICK HERE ]
Senior Director, Regulatory Affairs - [ CLICK HERE ]
Quality System Compliance, Supervisor Department: QA/RA - [ CLICK HERE ]
Global Marketing Manager - [ CLICK HERE ]
Quality Engineer II - [ CLICK HERE ]
Quality Engineer 1 - [ CLICK HERE ]
Advanced Quality Engineer (Vermont) - [ CLICK HERE ]
Quality Engineer - [ CLICK HERE ]
Regulatory Internship - [ CLICK HERE ]
Technician II - [ CLICK HERE ]
Electrical Engineering Co-Op - [ CLICK HERE ]
Senior Microbiologist - [ CLICK HERE ]
Regulatory Affairs Manager - [ CLICK HERE ]
Position: Quality Systems Director
Company: GE
Contact Name: Allyson Klasinski 414-815-1722
Contact Email: allyson.klasinski@ge.com
Job Description:
GE Healthcare provides transformational medical technologies that are shaping a new age of patient care. GE Healthcare’s expertise in medical imaging and information technologies, medical diagnostics, patient monitoring and life support systems, disease research, drug discovery, and biopharmaceutical manufacturing technologies is helping physicians detect disease earlier and to tailor personalized treatments for patients.
GE Healthcare offers a broad range of products and services that are improving productivity in healthcare and enhancing patient care by enabling healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 43,000 people committed to serving healthcare professionals and their patients in more than 100 countries. GE is an equal opportunity employer.
The Quality Systems Director is responsible for driving the vision, strategy, management and evolution of the Quality Management System (QMS).
Build your career and experience the advantages that come with working for one of the “World’s Most Admired Companies” (Fortune Magazine) offering significant opportunities for growth and career advancement!
Primary responsibilities include:
Driving Quality Objectives at all levels in the organization in order to form a sustainable quality culture; based on compliance to regulations, patient safety, and continuous improvement of quality processes to benefit the end customer.
Partnering with the business leadership team to drive wing-to-wing product quality through critical metrics trend analysis and implementation of improvement initiatives for the total product life cycle. Run the Executive Management Review of Quality data and objectives.
Acting as the interface between the business (P&L) and the Core QA/RA function, implementing Corporate GEHC programs in an appropriate compliant manner within the P&L.
Driving training, and adoption of the QMS documentation, framework and tools.
Direct management responsibility for Quality Analytics, Training, Document Management and Computer Systems Validation staff.
Providing effective guidance and oversight for quality processes, as well as owning key quality decisions for the total product life cycle.
Ensuring compliance to existing and applicable global Quality Systems Requirements.
Translating new industry trends and requirements into appropriate practices for the business.
Managing internal and external audits across the business sites to ensure compliance as required by the business and regulatory agencies.
Staffing and managing a globally disperse team of professionals with the required skills. and experience to effectively execute their job responsibilities.
Qualifications:
1. Bachelor’s degree in Engineering or Scientific discipline or High School diploma/GED and a minimum of 10 years Quality Management experience in the medical device or pharmaceutical industry
2. Minimum 7 years working in a Quality Management role in a regulated industry and experience interfacing with the FDA
3. Minimum of 5 years supervisory experience (i.e. managing professional direct reports), including hiring, training, coaching and performance management activities
4. Strong knowledge of quality systems, including but not limited to ISO, GxP, FDA
5. Willingness to travel globally 20% of the time
6. Ability to communicate in English (oral and written)
7. You must be willing to submit to a background investigation, including for example, verification of past employment, criminal history and educational background.
8. You must be willing to take a drug test
9. You must be legally authorized to work in the United States
10. You must be willing to work out of an office located in Salt Lake City, Utah
Position: Microbiologist - Quality
Company: Edwards Lifesciences
Contact Name: Andrea Pierson - 801-565-6223
Contact Email: Andrea_Pierson@Edwards.com
Job Description:
Edwards Lifesciences is a global leader in the development, manufacture and supply of cardiovascular products and services. We currently seek an accomplished employee to contribute to our team.
Qualifications:
* Conduct quality microbial monitoring program for medical device manufacture and sterilization, and quality assurance reviews.
* Perform microbiological testing for medical devices, manufacturing processes, systems, and facilities.
* Work with aseptic lab techniques, assays, pipetting, filtration, dilution techniques, biological indicators.
* Review and approve environmental monitoring data.
* Execute process validations/ revalidations, assisting with protocols, data analysis, temperature studies, and reports, to contribute to goal achievements.
* Microbial microscopic examination, and responsibility for setting up lab equipment and qualifications.
* Read and interpret microbiological cultures and other related tests, including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests and antimicrobial effectiveness tests.
* Utilize communication skills as an important member of audits, and for participation in team / global goals; apply judgment, support development projects, problem-solving leadership, impact evaluation, and apply regulatory compliance standards.
* Be part of a dynamic team environment, and Edwards life-saving values, where we also focus on employee engagement.
* Perform critical records documentation and participate in documentation preparation and assistance for regulatory audit review.
Multi-level position: Position title and level posted is preferred. However, depending on experience, we will consider hiring within these levels: Microbiologist I, Microbiologist II, Sr. Microbiologist.
Microbiologist I requires 2-4 years directly related experience; Microbiologist II requires a minimum of 4 years directly related experience. Sr. Microbiologist requires a minimum of 6 years directly related experience.
Experience to include experience in applicable lab techniques, validations, quality assurance evaluations, identifying microorganisms, and multi-tasking.
Required Education:
A bachelor's degree in Microbiology is required
Special Requirements:
Requires excellent communication skills, both verbal and written, and interpersonal skills to effectively interact with and contribute constructively to team environment/outside departments.
Proven experience in writing scientific reports and documents is desired.
Exposure to clean rooms, sterilization, and in validation studies, e.g. revalidation support testing, sterilizer operation/studies, and relevant ISO standards etc. is preferred.
Strong project management skills and strong leadership skills are required.
Position: Quality Systems Manager and Regulatory Affairs
Company: Dynatronics
Contact Name: Karen Morgan
Contact Email: kmorgan@dynatron.com
Job Description:
Responsible for the leadership, direction and management of all aspects of corporate Quality Systems, including but not limited to:
Management Representative for Quality System
Regulatory Affairs domestic and international
Corrective and Preventive Actions (CAPA)
Change Control
Documentation
Internal Audits
Quality Improvement Processes
Employee Training of Quality System
Draft and implement quality procedures
Qualifications:
This position reports to the CEO and supports improvement of Dynatronics’ processes in collaboration with R&D, Sales, Manufacturing, Technical Services and Finance.
BS degree
5 years experience in Quality and Process management preferred
Working knowledge of FDA Good Manufacturing Practices, ISO13485, and European MDD requirements
Position: Contracts Specialist / Project Manager
Company: Navigen Pharmaceuticals
Contact Name: Brandi Simpson 801-990-2498
Contact Email: brandisimpson@navigenpharma.com
Job Description:
Navigen Pharmaceuticals is a biotechnology start-up focused on drug discovery and early-stage development. Company management is committed to building a strong corporate culture with dedicated and happy employees. Navigen offers competitive compensation and benefits.
The successful applicant will support the administration, management, and oversight of a large research and development contract. Responsibilities will include:
Managing project timelines
Tracking internal and third-party work-streams to ensure timelines are met and/or delays are quickly communicated to stakeholders
Coordinating and negotiating with third-party vendors
Completing detailed and accurate reports
Monitoring third-party deliverables
Communicating project updates to Navigen executives and external stakeholders
Ensuring project remains within budget as possible and communicating necessary deviations from budget immediately
Qualifications:
Applicants must have at least a Bachelors degree and at least 2 years of relevant work experience as a project manager or contract specialist/manager. Experience with MS Office products including Word and Excel is required. Mastery of MS Project or other project management software is expected. Strong written and oral communication skills are also essential for success in this position. Additionally, candidates must also have at least three of the following:
Experience as a project manager in pharmaceutical development
Life sciences background
Direct experience with government contracts
Specialized training in finance, budgeting and/or accounting
PMP certification
Position: Quality Assurance Technician I
Company: USANA
Contact Name: Mark Andersen 801-954-7699
Contact Email: mark.andersen@us.usana.com
Job Description:
USANA is seeking a Quality Assurance Technician I to be responsible for all activities involving quality assurance and compliance with applicable cGMP and corporate quality requirements.
Responsibilities include creating Batch Production Records (BPR), reviewing and revising product specifications, along with establishing the master document filing system. The QA Technician I will review product procedures, specifications and work with other departments to ensure technical accuracy. The QA Technician I assists with the trending, and reporting of QA related information (Deviations, CAPA, OOS, Complaints, special projects), as it relates to product specifications and Master Product Records. In addition the QA Technician I will administer the internal product specification input program. The QA Technician I may assist in internal audits, investigations related to complaints and manufactured products, prepare routine status reports of Quality Assurance activities, and assist with preparation for regulatory inspections. The QA Technician I must be able to administer and control the preparation, formatting, distribution, auditing and maintenance of BPR’s.
Qualifications:
Candidates must have a high school diploma or GED, two years experience in R&D, regulatory or quality assurance / control from a life science or good manufacturing practice regulated industry. Candidates must have a working knowledge of cGMP or other quality programs, have strong written and oral skills, proficiency in English and be detail oriented.
Position: Engineering Internship -Material Science or Mechanical Engineering
Company: Bard Access Systems
Contact Name: Kate Van Rij (801) 522-5000
Contact Email: Kate.VanRij@crbard.com
Job Description:
This position reports to an Engineer on the Applied Research Technology team. This position will assist with engineering activities including: conduct tests, collect data, analyze data and prepare reports. Intern may assist with writing test methods and protocol. Intern may participate in design reviews.
Assists in the generation of formal test protocols and reports.
Assists in the execution of test protocols and procedures. Sets up and operates test equipment and records measurements with limited supervision.
Maintains accurate data and organizes and presents data in a reportable format.
Provides process/test method training to manager.
Complies with appropriate ISO, FDA and company policies and procedures.
Qualifications:
This position requires a student in the 2nd or 3rd year of a BS in Material Science or Mechanical Engineering. This position requires a basic knowledge and understanding of engineering principles.
Good personal computer software ability
Ability to work in a team environment
Good communication skills (verbal/written)
Ability to follow written and verbal instructions
Detail oriented
Basic math/statistics skills
Ability to collect, record and report data accurately
Mechanical aptitude
Ability to operate lab equipment
Position: Manager, Post-Market Surveillance
Company: GE Healthcare
Contact Name: Allyson Klasinski/414-815-1722
Contact Email: allyson.klasinski@ge.com
Job Description:
The Manager, Post-Market Surveillance is responsible for managing the personnel and processes associated to MDR and Vigilance reporting, tracking, trending and analysis of post market data, complaint handling and investigations, risk evaluations, corrections and removals of medical devices. The incumbent will ensure compliance with corporate procedures, as well as FDA and international regulations.
Lead a team of analysts as part of a complaint handling unit (CHU).
Responsible for compliance activities in accordance to the regulations and standards affecting Medical Devices (e.g. ISO 9001/13485/14971/14001, FDA Regulations (21CFR (803, 806, 820, part 11, etc)), CMDR, JPAL, and Medical Devices Directive (93/42/eec, 98/79/EC)).
Correspond with FDA post 806 actions, providing monthly status reports, as well as monitor the progress and effectiveness of corrective actions taken.
Ensure that appropriate training and education plans are developed, implemented and maintained for personnel in accordance to divisional, corporate and regulatory guidelines.
Continuously evaluate effectiveness of pertinent post market Quality Systems to determine gaps or areas for improvement; convey results of assessments with appropriate actions to management.
Serve as a subject matter expert for complex regulatory and compliance issues, including regulatory and procedural interpretations, processes such as quality hold, risk assessment, investigation, medical device reporting and tracking/trending analysis during audits, inspections and assessments by regulatory agencies and corporate bodies.
Work in partnership with Commercial Operation entities (Customer Service, R/D, Regulatory, Manufacturing, Legal, Quality, etc) in resolving customer issues and developing continuous process improvement initiatives.
Oversee post market cross-functional team meetings, and present complex data to Executive staff members.
Maintain, develop and implement processes for tracking, trending and analyzing post market data utilizing statistical tools and methodologies.
Comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
Complete all planned Quality & Compliance training within the defined deadlines.
Identify and report any quality or compliance concerns and take immediate corrective action as required.
Identify and report any compliance gaps related to the full Quality System Regulation (QSR) and Current Good Manufacturing Practices (CGMP).
Ensure all potential sources of product complaints are reviewed.
Timely complaint handling and reporting.
Provide objective evidence of complaint handling process through compliant documentation.
Qualifications:
Bachelors degree in engineering, Nursing or related scientific discipline required with a minimum of 3-5 years medical device experience (preferably in post market surveillance)
Ability to communicate using English.
Excellent working knowledge MDR and Vigilance reporting, tracking, trending and analysis of post market data, complaint handling and investigations, risk evaluations, corrections and removals of medical devices.
3 years experience with 21CFR Part 803: Medical Device Reporting.
3 years experience with 21CFR Part 806: Corrections and Removals.
3 years experience with 21CFR Part 820 (QSR), MDD, CMDR and JPAL.
Strong working knowledge of the regulations and standards affecting Medical Devices (e.g. ISO 9001/13485/14971/14001, FDA Regulations (21CFR (803, 806, 820, part 11, etc)), CMDR, JPAL, and Medical Devices Directive (93/42/eec, 98/79/EC)).
Excellent working knowledge MDR and Vigilance reporting, tracking, trending and analysis of post market data, complaint handling and investigations, risk evaluations, corrections and removals of medical devices.
Demonstrated Program management or leadership skills.
Working knowledge of GEHC products preferred.
Excellent interpersonal, organizational, communication and influencing skills.
Excellent team-player skills w/global mindset.
GEHC experience
Position: Senior Director, Regulatory Affairs
Company: Edwards Lifesciences
Contact Name: Nancy Boyd 949-250-3401
Contact Email: Nancy_boyd@edwards.com
Job Description:
The Senior Director, Regulatory Affairs, is a significant leadership role within our Regulatory Affairs program for one of Edwards’ largest and most prestigious businesses. Our Heart Valve Therapy franchise has been leading technological innovation in Heart Valves for over 50 years and we have a robust pipeline of new products within the $700 Million business. We are looking for a Regulatory Affairs professional with significant experience in implantable medical products (Class III). This individual will be a key player for the development and execution of our Regulatory strategy for new product development within this franchise.
Will develop, direct, and coordinate the execution of regulatory strategies for the Edwards Lifesciences heart valve product portfolio.
Ensure on-time completion of regulatory milestones, performance requirements and budgets are met.
Negotiate and communicate effectively both internally and externally with cross-functional project teams, management, regulatory agencies (i.e. FDA, TUV) and business partners to ensure objectives of programs are met on time. Directly participate in project teams.
Organize project and departmental objectives and delegate tasks effectively. Educate internal and external customers regarding regulatory requirements.
Qualifications:
A minimum of 15 years progressive experience within Medical Device Regulatory affairs and at least 5 years in a leadership role.
Must have a successful regulatory track record in the commercialization of innovative, complex medical devices (communications, IDE/PMA and Class III CE approvals).
A bachelor's degree in a related life sciences discipline is required; an advanced degree is preferred.
Requires proven track record with the ability to operate effectively in a diverse organization. History of effective interactions with FDA and other regulatory authorities required.
Expert regulatory knowledge and the ability to influence regulatory agency personnel are a must.
Excellent written and verbal communication skills and computer literacy are required.
Position: Quality System Compliance, Supervisor Department: QA/RA
Company: Integra LifeSciences Corporation
Contact Name: Emily Madsen 800-241-2210
Contact Email: emily.madsen@integra-ls.com
Job Description:
Reports To: Manager, Quality Assurance Location: IPM, Salt Lake City, Utah
Plans and conducts activities concerned with the quality control of medical device processes, materials, and products by performing the following duties. Responsible for customer complaint investigations, CAPA activities and daily supervision of QC inspectors.
Conduct complaint investigating duties in review of complaints, complaint product and complaint investigation.
Assist the Manager of Quality System Assurance in evaluating employee performance and preparing performance reviews.
Issue CAPA reports for internal audits and product-related issues and conduct all associated follow-up to ensure that corrective and preventative actions are effectively implemented.
Oversee and assist with complaint investigation and resolution.
Develop tracking and trending reports for complaint product.
Monitor the results of in-house and supplier quality (supplier ratings, complaint trends, non-conformity trends, etc) and assist with the formulation and implementation of improvements.
Prepare Certificates of Compliance/Assurance for customers and OEM partners.
Oversee internal audit system by scheduling and monitoring internal audits, while conducting the bulk of internal audits.
Assist Customer Service in answering customers’ quality/technical questions.
Gives and welcomes constructive feedback; contributes to building a positive team spirit.
Treats others with respect; works with integrity and ethically; upholds organizational values.
Performs general housekeeping duties within the area.
Observes company’s safety procedures and policy at all times.
This position will provide direct supervision for 3 – 6 inspectors.
Qualifications:
Minimum 3-5 years experience in Quality within an FDA regulated industry preferred.
Knowledge of FDA QSR and ISO Quality Standards
Ability to conduct Quality System Audits
Ability to analyze complex issues, conduct root cause investigations, and prepare reports on findings.
Position: Global Marketing Manager
Company: Cardiac Sector Medical Device (Northeast USA)
Contact Name: Deborah Kaufman, Healthcare Recruiting, Inc.
Contact Email: info@healthcare-recruiting.com
Job Description:
- Manage the product marketing effort and product management team [note: This position will have management responsibility over department Product Managers]
- Drive the development and execution of Market and Product strategies and tactical plans.
- Actively support the worldwide selling efforts, including close collaboration with the field sales force.
- Provide product, competitive, and clinical data analyses to global sales force.
- Create comprehensive marketing collateral based on clinical indication driven market segments, including design and execution of messaging, promotional materials, sales tools, and proof sources.
- Responsible for managing new product planning, including collaborating with product development teams to ensure process is focused on customer needs, minimizing time-to-market.
- Design and implement promotional programs to maximize impact of sales efforts.
- Manage the analysis of customer satisfaction data and apply such data to improve marketing and product strategies.
- Foster relationships with key clinicians/organizations within the industry.
www.healthcare-recruiting.com
Qualifications:
7-10 years of experience
CRDM and/or Electrophysiology experience is highly desirable
- Masters Degree/MBA preferred; minimum of 7-10 years of progressively responsible medical device marketing experience; PMA and IDE experience and a solid understanding of the regulatory requirements required; cardiac-sector marketing/product management experience a must. Medical device sales experience preferred.
- Strong analytical, strategic thinking and problem solving skills; strong verbal and written communication skills, and well-honed interpersonal and leadership skills are required.
- Ability to interpret and convey clinical data required.
- Independent thinking; self-starter with a high level of initiative and the ability to instill confidence with physician, customers, and key opinion leaders (KOLs) audiences
- Must be an effective team leader in a fast paced, high visibility environment.
Position: Quality Engineer II Salt Lake City, UT
Company: National Search Associates
Contact Name: Stephanie (Martin) Peluso 760-918-2892
Contact Email: StephanieP@nsasearch.com
Job Description:
This position is responsible for conducting engineering studies for process improvements and validations. This position designs, develops and implements new products, processes, test methods and equipment.
Potential Task Assignments within the scope of this position
1. Initiates new or revised documentation and tracks through appropriate approval cycles and implementation
2. Maintains a professional working relationship with internal & external customer and support staff
3. Participates and/or leads cross-functional teams.
4. Provides technical support on components, material methods, systems and equipment.
5. Develops physical and functional test requirements to assure specifications & regulations are met.
6. Writes and approves protocols, reports and data.
7. Oversees testing outlined in protocols and test methods
8. Coordinates/develops validation studies on equipment & processes
9. Understands and follows company procedures and regulatory requirements.
10. Participates in and provides input to training on department & division procedures, and policies.
11. Plans and coordinates engineering test builds.
12. Analyzes problems in design, process and test development. Recommend solutions.
13. Prepares and presents oral and written project updates and technical discussions.
14. Develops and implements procedures to provide easy-to-follow instructions.
Qualifications:
This position requires:
- an Associate technical degree with 8 (eight) years of engineering experience within the medical device or equivalent industry OR
- a Bachelor degree in science or engineering with 4 (four) year of engineering experience within the medical device or equivalent industry OR
- Masters degree with 3 (three) year of engineering experience within the medical device or equivalent industry OR
- Equivalent experience with 15 (fifteen) plus years of engineering experience within the medical device or equivalent industry
Responsible for systems assurance including documentation, testing and inspection, product and process development, and non-conforming product investigations. Will support Manufacturing, New Product Development, and Regulatory to ensure systems are in compliance with all internal and external guidelines.
Position: Quality Engineer 1
Company: National Search Associates
Contact Name: Stephanie (Martin) Peluso 760-918-2892
Contact Email: StephanieP@nsasearch.com
Job Description:
Salt Lake City position
Qualifications:
Electronic engineering background preferred, experience with programming helpful.
Position: Advanced Quality Engineer (Vermont)
Company: National Search Associates
Contact Name: Stephanie (Martin) Peluso 760-918-2892
Contact Email: StephanieP@nsasearch.com
Job Description:
Plans and directs all quality engineering activities for new product launches. Responsible for process from disciplined requirement reviews through highly standardized IQ/OQ/PQ validation protocols. Works with the Engineering Team and customers to ensure advanced quality plans such as inspection and control plans, process flow diagrams, SPC plans, and FMEA's are initiated during the earliest stages of each program.
Qualifications:
Must be experienced in injection molding tight tolerance medical parts, and have experience writing and carrying out IQ/OQ/PQ validation protocols in a medical environment. Familiarity with sub-assemblies and contract manufacturing preferred. Engineering or technical degree and/or at least 10 years experience in precision molding and quality assurance desired.
Position: Quality Enginneer
Company: National Search Associates
Contact Name: Stephanie (Martin) Peluso 760-918-2892
Contact Email: StephanieP@nsasearch.com
Job Description:
We have immediate needs for QAs and QEs from junior to senior levels.
Qualifications:
MUST have Medical Device experience, failure analysis and be able to work cross functionally with Regulatory and Manufacturing.
Position: Regulatory Internship
Company: Bard Access Systems
Contact Name: Kate VanRij (801) 522-4993
Contact Email: Kate.VanRij@crbard.com
Job Description:
This position provides support to the Regulatory Affairs Department. Intern manages projects as assigned by the Regulatory Manager. Hours are flexible, Part or Full time. Compensation is $13.90 per hour.
Assists in the writing, compilation and assembly of various RA submissions such as 510(k)s, PMA supplements, and other submissions.
Assists in the preparation of division procedures to ensure compliance with Regulatory and Corporate requirements.
Assists with Regulatory Affairs projects and related tasks.
Maintains general RA files.
Assists in the administration of R-002 activities (product recalls, field corrections, no recall rationales, etc.)
Qualifications:
We are currently seeking an undergraduate student pursuing a degree in English, Law, Biology, Engineering, Communications, Business or other related field. Must have demonstrated communication skills, strong organizational skills, and proficiency in word processing.
-Proficient in WordPerfect
-Strong communication and organizational skills.
-Grammar, editing, and proofreading skills.
-Excellent follow-through.
-Ability to maintain confidentiality.
Position: Technician II
Company: Bard Access Systems
Contact Name: Kate VanRij (801) 522-4993
Contact Email: Kate.VanRij@crbard.com
Job Description:
This position assists with engineering activities and performs tasks associated with those activities.
Generates formal test protocols and reports.
Executes test protocols and procedures. Sets up and operates test equipment and records measurements.
Maintains accurate data and assists with analysis.
Provides process/test method training to manufacturing/QC personnel and other technicians.
Develops and maintains a working knowledge of BAS policies and procedures, ISO and FDA requirements.
Generates, expedites and tracks Development Builds.
Assists in conceptual input to the design of fixtures, tooling and equipment, as well as assists with recommendation, specification and procurement of capital equipment.
Achieves “Operator” certification status for test equipment applicable to assigned area of responsibility.
Qualifications:
This position requires:
- an Associate's Degree in science, math or engineering with two years related experience, or
- a minimum of six years related experience
Ability to enter data in Minitab and/or Microsoft Project and/or
Ability to read and understand CAD drawings (e.g. Solidworks)
Interpret and understand geometric tolerancy
Ability to analyze and evaluate data and recommend actions
Ability to write technical reports/protocols
Ability to coordinate test protocols
Ability to design (fixture, equipment and testing)
Ability to train lower level technicians and floor operators
Ability to work with little supervision
Ability to operate laboratory equipment within the area of assigned responsibilities
Position: Electrical Engineering Co-Op
Company: Bard Access Systems
Contact Name: Kate VanRij (801) 522-4993
Contact Email: Kate.VanRij@crbard.com
Job Description:
We are seeking an Electrical Engineering student that can start working as a co-op right away 20 hours a week. Scheduling will be flexible, student will design their own work schedule around classes. We are hoping to find a student that will work in this co-op for at least a year. Full time hours are available in the summer.
This position reports to an Engineer on the Ultra Sound team. This cross functional team is responsible for the design and maintenance of Bard Access System's Ultrasound Devices. These devices are used to help nurses place a PICC correctly in the patient's body. For more information about these products please visit www.bardaccess.com.
This position will assist with engineering activities including: conduct tests, collect data, analyze data and prepare reports. Intern may assist with writing test methods and protocol. Intern may participate in design reviews.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1.Assists in the generation of formal test protocols and reports.
2.Assists in the execution of test protocols and procedures. Sets up and operates test equipment and records measurements with limited supervision.
3.Maintains accurate data and organizes and presents data in a reportable format.
4.Provides process/test method training to manager.
5.Complies with appropriate ISO, FDA and company policies and procedures.
Qualifications:
1.Good personal computer software ability
2.Ability to work in a team environment
3.Good communication skills (verbal/written)
4.Ability to follow written and verbal instructions
5.Detail oriented
6.Basic math/statistics skills
7.Ability to collect, record and report data accurately
8.Mechanical aptitude
9.Ability to operate lab equipment
Position: Senior Microbiologist
Company: Ortho Development Corporation
Contact Name: Tom Waddoups Fax (801)619-8943
Contact Email: hr@odev.com
Job Description:
Ortho Development Corporation, an expanding orthopedic device manufacturer is seeking a Sr. microbiologist. Duties include coordinating contract testing, monitoring clean room and water system, performing sterilization validations and conducting internal audits. Will prepare and update standard operating procedures and test protocols. Will also design and conduct process improvement projects and assist in third party audits. Ortho offers excellent pay and top level benefits.
Please send resume along with salary requirements to the aforementioned contact person.
Qualifications:
The ideal candidate must have a bachelor degree in microbiology, or other biological science and have 4-6 years of microbiologist experience. Ability to interpret and evaluate test data and prepare appropriate reports required.
Position: Regulatory Affairs Manager
Company: Ortho Development Corporation
Contact Name: Tom Waddoups Fax (801)619-8943
Contact Email: hr@odev.com
Job Description:
Ortho Development Corporation, an exciting, rapidly growing orthopedic implant manufacturer is seeking to add a Regulatory Affairs Manager to our medical device team.
Duties include device classification and associated strategy development, product registration, medical device tracking/control systems, and post market surveillance. Will also act as liaison with regulatory agencies.
Qualifications:
The ideal candidate will possess 6 years medical device manufacturing experience including experience with pre-market notification, managing clinical studies, and overseeing regulatory compliance for product labeling.
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