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Biocompatibility Medical Device Jobs (NOW HIRING)

AbbVie

Scientist II - Biocompatibility

Branchburg, NJ · On-site

The Scientist II - Biocompatibility is a SME which will provide highly skilled support for ... Maintain knowledge of medical device regulations to assure compliance and conformance of programs ...

AbbVie

Scientist II - Biocompatibility

Branchburg, NJ · On-site

$78K/yr

The Scientist II - Biocompatibility is a SME which will provide highly skilled support for ... Maintain knowledge of medical device regulations to assure compliance and conformance of programs ...

Kelly Services

Biocompatibility Coordinator

Blue Ash, OH · On-site +1

$37/hr

Biocompatibility Coordinator At Kelly ® Science, Engineering, Technology & Telecom (SETT), we're ... Experience with medical device/pharmaceutical industry is preferred. * Familiarity with ISO 10993 ...

Gentueri

Be Seen First

Quality Manager - Medical Device Company

Middleton, WI · On-site

$30 - $35/hr

... ISO 10993 (biocompatibility), and ISO 11607 (sterile packaging). * ISO 13485 Lead Auditor ... based medical device company that designs and manufactures non-invasive biological sample ...

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All JobsBiocompatibility Medical Device Jobs

Biocompatibility Medical Device information

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How much do biocompatibility medical device jobs pay per hour?

As of Jun 9, 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.
Engineer Senior, Drug Delivery Medical Device Biocompatibility (JP12000)

Engineer Senior, Drug Delivery Medical Device Biocompatibility (JP12000)

3 Key Consulting

Thousand Oaks, CA

$45 - $50/hr

Other

Posted 22 days ago

Job description

Job Title: Engineer Senior, Drug Delivery Medical Device (JP12000)
Location: Thousand Oaks, CA. 91320
Business Unit: Design Control
Employment Type: Contract
Duration: 1+ years (with possible extensions)
Rate: $45 - $50/hour W2
Posting Date: 11/30/2023
Notes: Only qualified candidates need apply.
3 Key Consulting is recruiting an Engineer Senior, Medical Device Biocompatibility for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
The ideal candidate for this role is a highly qualified professional with a Bachelor's degree in Science or Engineering and a minimum of 5 years of experience in the medical device industry. They possess a robust understanding of ISO 10993 biocompatibility standards, particularly parts 3, 4, 6, 7, 11, and 18, along with expertise in drug/device combination product design and development. With a solid grasp of Medical Device Regulations such as 21CRF820 and ISO 13485, excels in assessing and ensuring regulatory compliance. Excellent communication skills, both written and verbal, enable effective coordination with diverse stakeholders, and they exhibit strong problem-solving abilities. A team player with meticulous attention to detail, thrives in a deadline-driven environment, managing multiple projects while maintaining cross-functional alignment and presenting detailed information to governance bodies.
Top Must Have Skill Sets:
1) Expertise in ISO 10993 biocompatibility standard, especially parts 3,4,6,7,11, and 18.
2) Familiarity with Medical Device Regulations (21CFR820 and ISO 13485),
3) Good communication skills to coordinate standard assessments.
Day to Day Responsibilities:
Detailed technical assessment of new/revised external requirements.
Coordinate the assessment of changes to external requirements in collaboration with other Subject Matter Experts.
Conduct document management system search for impacted records and disposition documents accordingly.
Communicate outcome of technical decisions to all impacted platform and product teams.
Coordinate with all impacted product teams to complete integration of requirement or justify no action and document it in Product Impact Assessment
Maintain cross-functional, platform and product alignment.
Present summary of details and advice to Product External Requirement governance for a decision on Amgen's position regarding a standard's impact.
Basic Qualifications:
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
- BS in Science or Engineering and previous experience in a medical device industry - 5 years current medical device industry experience .
- Strong Expertise in ISO 10993 biocompatibility standard, especially parts 3,4,6,7,11, and 18
- Experience in drug/device combination product design and development - Familiar with with Medical Device Regulations (21CRF820 and ISO 13485).
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Strong Problem solving and communication skills.
- Must be capable of working on multiple projects in a deadline driven environment.
Red Flags:
Not employed for more than 6 months.
Interview Process:
Phone / Webex interview
We invite qualified candidates to sendyour resume toresumes@3keyconsulting.com. Ifyou decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our websitewww.3keyconsulting.com/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.

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