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Biocompatibility Medical Device Jobs (NOW HIRING)

Tunnell Government Services

Toxicologist

Bethesda, MD · On-site

ISO TS 21726:2019, Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents * ICH M7 ...

millenniumsoft

NC · On-site

Medical Device Company Job Category: Research & Development Level Of Experience: Entry Level ... This position works as a member of the biology group and is responsible for biocompatibility ...

millenniumsoft

NC · On-site

Medical Device Company Job Category: Research & Development Level Of Experience: Mid-Level ... This position works as a member of the biology group and is responsible for biocompatibility ...

Tunnell Government Services

Toxicologist

Bethesda, MD · On-site

ISO TS 21726:2019, Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents * ICH M7 ...

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Biocompatibility Medical Device information

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How much do biocompatibility medical device jobs pay per hour?

As of Jun 10, 2026, the average hourly pay for biocompatibility medical device in the United States is $49.84, according to ZipRecruiter salary data. Most workers in this role earn between $35.10 and $59.62 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Biocompatibility Medical Device Specialist, and why are they important?

To thrive as a Biocompatibility Medical Device Specialist, you need a strong background in biomedical engineering, materials science, or a related field, along with knowledge of regulatory standards like ISO 10993. Familiarity with laboratory testing, risk assessment tools, and regulatory submission systems is typically required, and certifications such as RAC (Regulatory Affairs Certification) can be advantageous. Critical thinking, attention to detail, and effective cross-functional communication are standout soft skills for this role. These skills and qualities are crucial to ensure device safety, regulatory compliance, and successful product development in the medical device industry.

What are the typical challenges faced by professionals working in biocompatibility for medical devices?

Professionals in biocompatibility for medical devices often face the challenge of navigating complex regulatory requirements while ensuring accurate testing and documentation. They must stay updated with evolving standards such as ISO 10993 and communicate effectively with cross-functional teams, including R&D, regulatory affairs, and manufacturing. Balancing thorough risk assessments with project timelines can be demanding, and close attention to detail is crucial when interpreting test results and preparing submission reports. Collaboration and adaptability are key to overcoming these challenges and ensuring patient safety.

What is a biocompatibility specialist for medical devices?

A biocompatibility specialist for medical devices is a professional responsible for evaluating whether a medical device is safe and compatible with human tissue. Their main role is to assess the potential for adverse biological reactions when a device comes into contact with the body. They design and oversee tests to ensure devices meet regulatory standards, such as ISO 10993, and help prepare documentation for regulatory submissions. This role is crucial in ensuring that products are safe for patients and comply with global health regulations.

What is the difference between Biocompatibility Medical Device vs Biocompatibility Specialist?

AspectBiocompatibility Medical DeviceBiocompatibility Specialist
CredentialsRegulatory knowledge, testing certificationsBiocompatibility testing certifications, scientific background
Work EnvironmentManufacturing, testing labs, regulatory agenciesResearch labs, testing facilities, regulatory bodies
Industry UsageDesign, manufacture, and approval of medical devicesConducting biocompatibility assessments and research

The main difference is that a Biocompatibility Medical Device refers to the actual device designed for medical use, while a Biocompatibility Specialist focuses on testing and assessing the device’s biocompatibility to ensure safety and compliance.

Infographic showing various Biocompatibility Medical Device job openings in the United States as of June 2026, with employment types broken down into 99% Full Time, and 1% Part Time. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $103,662 per year, or $49.8 per hour.
Sr. Design Assurance Engineer - Medical Device

Sr. Design Assurance Engineer - Medical Device

RESOLUTION MEDICAL LLC

Fridley, MN

$120K - $150K/yr

Other

Medical, Dental, Vision, Life, Retirement

Posted 4 days ago

Job description

Description

Job Summary:

The Senior Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization working with cross-functional development teams to establish and maintain the design control deliverables, risk management activities, and DHF compliance to ensure delivery of the highest quality product to the customer.


Essential Functions:

  • Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects and leading on-time completion of protocols, reports and assigned project deliverables
  • Accountable for Design Verification and Validation planning and /or, including active cross-functional root-cause analysis investigation & resolution activities
  • Lead Risk Management activities from product Concept through Commercialization
  • Support design test and inspection method development, and lead method validation activities
  • Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps
  • Support and ensure internal & external audit responses and on-time product re-certifications
  • Support and ensure the establishment of objective, measurable, discrete, and verifiable customer, and product requirements
  • Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Provide support for biocompatibility and sterilization qualifications
  • Develop and lead other team members and provide work direction as required
  • May have 2-3 technicians assigned for inspection, testing and project support
  • Performs other functions as required

Requirements

Education, Experience, and Required Skills:

  • BS Industrial Engineering, Engineering or Business Degree
  • 8-15 years of medical device experience in Quality Operations, or equivalent experience
  • 1-3 years of direct or indirect supervisory experience preferred
  • Comprehensive understanding of FDA regulations, ISO 13485, ISO 14971

Preferred Skills:

  • Statistical and data analysis
  • Supervisory, Solid Management and Strong Leadership experience

Physical Requirements:

  • Prolonged periods sitting at a desk and working on a computer
  • Must be able to lift 25 pounds at times
  • Must have manual dexterity
  • Must have excellent hand-eye coordination
  • Must wear gown, gloves, and ear protection if applicable

Summary of Benefits

  • Group health & welfare benefits: Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan), and Flexible Spending Accounts.
  • Company-paid benefits: Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Kavira (requires participation in medical plan).
  • Voluntary, employee-paid benefits: Employee Supplemental Life & AD&D, Spouse and Dependent Life & AD&D, Short Term Disability (STD), Accident, Critical Illness, and Hospital Indemnity, Employee Assistance Program.
  • Flexible Time Off Program
  • Paid Parental Leave
  • Paid Holidays
  • Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.

Compensation

  • The typical base pay range for this role is between $120,000-150,000/year. Compensation will vary based on individual job-related knowledge, skills, expertise, and experience. This position is eligible for a discretionary annual incentive program driven by organization and individual performance.
  • 401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings.



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