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Biocompatibility Jobs (NOW HIRING)

Medtronic

PD Program Manager

Lafayette, CO · On-site

$163K - $204K/yr

Ensure compliance by navigating and adhering to government and industry regulations including FDA QSR 21 CFR 820, ISO 13485 (Medical Device), ISO 10993 (Biocompatibility), IEC 62366 (Usability ...

Medline

Principal Toxicologist

Northfield, IL · On-site +1

$152.88K - $229.32K/yr

Conduct and interpret chemical characterization (e.g., E&L studies, ISO 10993-18, ISO 18562), SAR/QSAR modeling, and guide biocompatibility testing under GLP requirements. * Serve as a subject matter ...

Medtronic

PD Program Manager

Lafayette, CO · On-site

$163K - $204K/yr

Ensure compliance by navigating and adhering to government and industry regulations including FDA QSR 21 CFR 820, ISO 13485 (Medical Device), ISO 10993 (Biocompatibility), IEC 62366 (Usability ...

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Biocompatibility information

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$41K

$115.4K

$214K

How much do biocompatibility jobs pay per year?

As of May 30, 2026, the average yearly pay for biocompatibility in the United States is $115,369.00, according to ZipRecruiter salary data. Most workers in this role earn between $84,000.00 and $135,500.00 per year, depending on experience, location, and employer.

What is a Biocompatibility job?

A Biocompatibility job involves evaluating medical devices, materials, and implants to ensure they are safe and non-toxic for human use. Professionals in this role analyze the interactions between biomaterials and biological systems, conducting risk assessments and regulatory compliance reviews. They work closely with engineers, scientists, and regulatory teams to meet standards like ISO 10993. This job is critical in ensuring patient safety and securing product approvals for medical devices.

What are the key skills and qualifications needed to thrive in the Biocompatibility position, and why are they important?

To thrive in a Biocompatibility role, you typically need a background in biomedical engineering, materials science, or a related life science field, with strong knowledge of biological safety and regulatory requirements for medical devices. Familiarity with ISO 10993 standards, biocompatibility testing methods, and data analysis tools is essential, along with potential certification in regulatory affairs or toxicology. Attention to detail, effective communication, and problem-solving abilities are vital soft skills for collaborating across multidisciplinary teams. These skills ensure accurate safety evaluations and regulatory compliance, which are crucial for bringing safe and effective medical products to market.

What are typical daily responsibilities for someone working in Biocompatibility?

Professionals in Biocompatibility routinely assess the biological safety of new materials or devices, design or coordinate laboratory tests, and analyze results to determine compliance with regulatory standards. Their day-to-day work often involves preparing technical reports, collaborating with R&D and regulatory teams, and communicating findings to project stakeholders. You may also contribute to risk assessments, provide input during product development stages, and stay updated on evolving international regulations. This role requires balancing technical expertise with proactive communication to ensure the safe and timely approval of medical products.
More about Biocompatibility jobs
What cities are hiring for Biocompatibility jobs? Cities with the most Biocompatibility job openings:
What are the most commonly searched types of Biocompatibility jobs? The most popular types of Biocompatibility jobs are:
What states have the most Biocompatibility jobs? States with the most job openings for Biocompatibility jobs include:
What job categories do people searching Biocompatibility jobs look for? The top searched job categories for Biocompatibility jobs are:
Biocompatibility jobs near you
Infographic showing various Biocompatibility job openings in the United States as of May 2026, with employment types broken down into 98% Full Time, and 2% Contract. Highlights an 95% Physical, and 5% Remote job distribution, with an average salary of $115,369 per year, or $55.5 per hour.

Senior Quality Engineer

Willow Innovations

Mountain View, CA • Hybrid

$180K - $200K/yr

Other

Posted 5 days ago

Job description

Job Overview:

The Senior Quality Engineer will participate in the implementation and maintenance of QSR (21 CFR 820) and ISO 13485: 2016 quality systems and qualification activities of Willow Innovations medical breast pump products and non-medical consumer products in support of the Company's development, manufacturing, quality, regulatory, and clinical affairs efforts. In addition, this position will support the development and implementation of quality systems, quality/reliability engineering disciplines, and compliance activities.

Roles & Responsibilities | What you'll do:

1. Drive Design Assurance in Product Development
  • Ensure compliance with design control requirements (ISO 13485, FDA 21 CFR Part 820, EU MDR, and Health Canada regulations) throughout the product lifecycle.
  • Partner with R&D and cross-functional teams to implement risk-based approaches to product design.
  • Develop and maintain Design History Files (DHF) to support regulatory submissions and audits.
2. Conduct Risk Management Activities
  • Lead Failure Modes and Effects Analysis (FMEA) for design, process, and usability risks.
  • Ensure compliance with ISO 14971 risk management requirements.
  • Facilitate risk assessments and collaborate with cross-functional teams to mitigate potential hazards.
3. Develop and Execute Verification & Validation (V&V) Plans
  • Define test strategies, acceptance criteria, and protocols for design verification and validation.
  • Review and approve test reports and data analysis to ensure compliance with regulatory standards.
  • Maintain traceability from user needs to design inputs, outputs, and validation results.
4. Ensure Compliance with Regulatory & Quality Standards
  • Support internal and external audits related to design assurance and regulatory compliance.
  • Ensure documentation aligns with FDA QMSR, EU MDR, ISO 13485, IEC 62304 (Software),  IEC 60601 (Safety), IEC 62366 (Usability),Health Canada MDR (SOR/98-282), and ISO 10993-1 Biocompatibility, FDA/EU/UK Food Safe Regulations, UL WERCSmart, REACH & RoHS.
5. Support Design Transfer & Manufacturing Readiness
  • Collaborate with manufacturing and suppliers to ensure design for manufacturability (DFM) and process validation.
  • Define quality control plans and inspection criteria for new products.
  • Conduct supplier quality assessments and ensure compliance with component specifications.
6. Drive Continuous Improvement in Quality Systems
  • Identify opportunities to enhance design control processes and documentation.
  • Develop and refine standard operating procedures (SOPs) for design assurance activities. 

Experience | What you'll bring:

  • Education: Bachelor's degree in Engineering, Biomedical Engineering, or a related field.
  • Experience: Minimum 10 years in medical device quality engineering with a focus on design assurance.
  • Regulatory Knowledge: Strong understanding of ISO 13485, FDA 21 CFR Part 820 & Part 11, EU MDR, ISO 14971 (Risk Management), ISO 10993-1 Biocompatibility, FDA/EU/UK Food Safe Regulations, WERCSmart, RoHS compliance.
  • Technical Skills: Experience with risk management tools (FMEA, Hazard Analysis), design verification/validation, and statistical methods.
  • Software Skills: Proficiency in MS Office, Quality Management Systems (QMS), and statistical tools (Minitab, Tableau).
  • Soft Skills: Strong analytical, problem-solving, and cross-functional collaboration skills.
  • Physical abilities:
    • Ability to work in an office setting, collaborating with R&D and manufacturing teams.

Occasional travel may be required for supplier audits, manufacturing support, or regulatory interactions. This is a hybrid role based in Mountain View, CA. The salary range for this position is $180,000-$200,000/year depending on experience.

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