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Biocompatibility Manager Jobs in Minnesota (NOW HIRING)

Actalent

Design Engineer II

Minneapolis, MN

Participate in risk management activities including risk analysis, FMEA, mitigation planning, and ... biocompatibility, and regulatory submission support. * Experience designing plastic, machined ...

Evergen

Sr. R&D Engineer

Eden Prairie, MN · On-site

$100K - $130K/yr

Medical Device Design Control and Risk Management: * Leveraging a high level of experience and ... Identify and lead interactions with external vendors such as test labs (e.g. biocompatibility ...

Coloplast

Regulatory Affairs Specialist

Minneapolis, MN · On-site

$107 - $161/hr

Analyze, summarize, prepare, and present data for Management Review meetings. * Maintain RA ... Experience with recalls, adverse event reporting, biocompatibility, claims review, and post-market ...

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Biocompatibility Manager information

What does a biocompatibility manager do?

A Biocompatibility Manager oversees the evaluation and testing of medical devices and materials to ensure they are safe and compatible with human tissues. Their responsibilities include designing testing protocols, interpreting regulatory requirements, and ensuring compliance with international standards like ISO 10993. They work closely with research, development, and regulatory teams to address any risks related to biological safety. Their work is critical for gaining regulatory approvals and ensuring patient safety.

What are the key skills and qualifications needed to thrive as a biocompatibility manager?

To thrive as a Biocompatibility Manager, you need expertise in toxicology, materials science, and regulatory standards, typically supported by a degree in a life science field and experience with medical device biocompatibility testing. Familiarity with ISO 10993 standards, risk assessment tools, and regulatory submission systems is essential. Strong analytical thinking, attention to detail, and effective communication skills help in collaborating with cross-functional teams and ensuring regulatory compliance. These skills and qualities are vital for ensuring product safety, regulatory approval, and successful market entry for medical devices.

What are the common challenges a biocompatibility manager faces when coordinating cross-functional teams during product development?

A Biocompatibility Manager often encounters challenges in aligning the priorities and timelines of various teams such as R&D, regulatory affairs, and quality assurance. Ensuring clear communication about testing requirements and regulatory updates is vital, as misunderstandings can lead to delays or non-compliance issues. Additionally, the manager must balance thorough risk assessments with project deadlines, all while staying current with evolving international standards. Effective collaboration and proactive problem-solving are key to overcoming these challenges and ensuring the safety and compliance of medical devices.

What is the difference between Biocompatibility Manager vs Biocompatibility Specialist?

AspectBiocompatibility ManagerBiocompatibility Specialist
CredentialsTypically requires a degree in life sciences or biomedical engineering; certifications like ISO 10993 are commonSimilar educational background; often holds certifications in biocompatibility testing
Work EnvironmentOversees teams, manages projects, and ensures compliance across departmentsPerforms testing, data analysis, and reports within labs or R&D settings
Industry UsageUsed in regulatory, quality assurance, and management roles within medical device companiesPrimarily involved in testing and technical analysis within laboratories

The main difference is that the Biocompatibility Manager oversees testing programs and compliance strategies, while the Biocompatibility Specialist focuses on conducting tests and technical analysis. Both roles require similar credentials but differ in scope and responsibilities.

What are popular job titles related to Biocompatibility Manager jobs in Minnesota?

For Biocompatibility Manager jobs in Minnesota, the most frequently searched job titles are:

What job categories do people searching Biocompatibility Manager jobs in Minnesota look for?

The top searched job categories for Biocompatibility Manager jobs in Minnesota are:

What cities in Minnesota are hiring for Biocompatibility Manager jobs?

Cities in Minnesota with the most Biocompatibility Manager job openings:

Biocompatibility Manager jobs near you
Infographic showing various Biocompatibility Manager job openings in Minnesota as of August 2026, with employment types broken down into 87% Full Time, and 13% Contract. Highlights an 84% In-person, and 16% Remote job distribution.

Associate Study Coordinator- ISR & Biocompatibility

NAMSA

Minneapolis, MN • On-site

$24/hr

Full-time

Posted 29 days ago

NAMSA rating

8.3

Company rating: 8.3 out of 10

Based on 16 frontline employees who took The Breakroom Quiz

36th of 120 rated laboratories

Job description

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.

We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.

Come and work for an organization with the:

Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the

Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core

Values:

  • Act with integrity in everything we do.
  • Provide best-in-class customer experiences.
  • Develop superior talent and deliver expertise.
  • Respond with agility and provide timely results.
  • Embrace collaboration, diverse perspectives and ideas.

Compensation Target:


$24.00

Job Description:

Knows and understands the Animal Welfare Requirements and serves as a support to the Study Directors and/Principal Investigator, when applicable.
Assists Study Directors on select projects under the direction and review of the Study Director team.
Assists in collection, documentation and analysis of pre-clinical data.
Assists in the coordination of study tasks from pre-study initiation to study completion.
Performs accurate and timely record keeping consistent with the maintenance of facility SOPs. Utilizes computer systems to enter and reference data as needed.
Assists in study planning and design of studies, under the direction and review of the study director team, to meet desired project endpoints, including coordinating pre-study meetings and data review.
Responsible for study planning activities, assists with generating study protocols when directed, coordinates and monitors activities in support of study conduct.
Communicates effectively with Sponsors, Study Directors, Principal Investigators and Testing Facility Management on the progress of all studies.
Assists with data collection, database entry and generating/tabulating data.
Distributes study related documents, i.e. copies of study data sheets
Creates documentation per SOP to assist with test/control article accountability.
May ship specimens, documents, CDs, DVDs etc. per SOP, maintaining accurate chain of custody documentation.
Assists with generating technical reports as directed and assist in identifying issues and recommend solutions.
Maintains client inventory and is required to be familiar with internal and competitor products.
Types correspondence and various types of documentation in proper format and proofreads/distributes as assigned.
Completes special department projects and duties (i.e., data collection, report creation, information maintenance, contacting personnel for routine updates, etc.) as required to support daily business operations.
Other duties as assigned.

Qualifications & Technical Competencies:

One year experience in an administrative position desirable, preferably with an emphasis in a laboratory setting.
Working knowledge of word processing and spreadsheet software.
Requires a minimum of an Associate degree, preferably in a scientific discipline.

Working Conditions:

While performing the duties of this job, the Associate is regularly exposed to general office conditions, and will be required to regularly work on personal computers and keyboards. The Associate is frequently exposed to a variety of livestock, domestic and laboratory animals and to fluoroscopy and faxitron x-ray imaging. The Associate is occasionally exposed to sharp objects, radioactive isotopes, gasses such as CO2 and isoflurane, toxic or caustic chemicals, and a Bio-Safety-Level 2 (BSL2) environment. On rare occasions, the Associate may be exposed to zoonotic diseases and blood borne pathogens.
The noise level in the work environment is usually moderate.
While performing the duties of this job, the Associate is regularly required to sit, stand, walk, use hands and fingers, reach with hands and arms, talk and hear, use computer keyboard, and view computer monitors. The Associate must occasionally lift and/or move up to 50 pounds.
Specific vision abilities required by this job include close vision, the ability to adjust focus, exceptional spatial acuity and visual-kinesthetic coordination.


The compensation grade range for this position is:

$18.32 - $35.82

-

Hourly

Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.


NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.

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