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Biocompatibility Engineer Jobs (NOW HIRING)

SharkNinja

Compliance Engineer

Needham, MA · On-site

Biomedical/Bioengineering backgrounds are well-suited to ISO 10993 biocompatibility and clinical evaluation; Systems Engineering to ISO 14971 risk management and design controls; Chemical/Materials ...

Innovative Health LLC

Sr. R&D Engineer

Scottsdale, AZ · On-site

$101K - $139K/yr

... biocompatibility requirements. · Develop and maintain relationships with key opinion leaders and ... in engineering discipline (or equivalent experience) · Minimum experience: 6 - 8+ years of ...

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Innovative Health

Sr. R&D Engineer

Scottsdale, AZ · On-site

$105K - $144K/yr

... biocompatibility requirements. · Develop and maintain relationships with key opinion leaders and ... in engineering discipline (or equivalent experience) · Minimum experience: 6 - 8+ years of ...

Innovative Health LLC

Sr. R&D Engineer

Scottsdale, AZ · On-site

$101K - $139K/yr

... biocompatibility requirements. • Develop and maintain relationships with key opinion leaders and ... engineers and technicians Education, Qualifications and Skills: • Bachelor's degree in ...

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Biocompatibility Engineer information

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$33K

$89.2K

$142K

How much do biocompatibility engineer jobs pay per year?

As of Jul 6, 2026, the average yearly pay for biocompatibility engineer in the United States is $89,183.00, according to ZipRecruiter salary data. Most workers in this role earn between $66,500.00 and $109,000.00 per year, depending on experience, location, and employer.

What is the difference between Biocompatibility Engineer vs Materials Scientist?

AspectBiocompatibility EngineerMaterials Scientist
Required CredentialsBachelor's or Master's in biomedical engineering, biology, or related fields; certifications in biocompatibility testingBachelor's or Master's in materials science, chemistry, or engineering; advanced degrees often preferred
Work EnvironmentMedical device companies, research labs, regulatory agenciesResearch institutions, manufacturing, aerospace, automotive industries
Industry UsageDesign and testing of biocompatible medical devices and implantsDevelopment of new materials for various applications, including medical, industrial, and consumer products

While both roles involve materials and testing, a Biocompatibility Engineer specializes in ensuring materials are safe for medical use, focusing on biological interactions. A Materials Scientist has a broader scope, working on developing and analyzing materials across multiple industries. The two roles often collaborate but serve distinct functions within product development and safety assurance.

What is a biocompatibility scientist?

A biocompatibility scientist is a professional who evaluates the safety of medical devices and materials by testing their interactions with biological systems. They often work in laboratories, using assays and standards such as ISO 10993 to assess potential adverse effects and ensure regulatory compliance.

Is there a demand for bioengineers?

There is strong demand for bioengineers, including biocompatibility engineers, due to the growth of the medical device and healthcare industries. These professionals are needed to develop and test biocompatible materials and devices, often requiring knowledge of materials science, biology, and regulatory standards. Job prospects are favorable with opportunities in research, development, and quality assurance roles.

Can a biomedical engineer make 200k?

Biomedical engineers, including biocompatibility engineers, can potentially earn $200,000 or more annually, especially with advanced experience, specialized skills, leadership roles, or working in high-paying industries like medical device manufacturing. Achieving this salary often requires a combination of advanced education, certifications, and years of experience in the field.

What does a Biocompatibility Engineer do?

A Biocompatibility Engineer is responsible for evaluating and ensuring that materials and devices intended for medical use are safe and compatible with biological systems. Their work involves assessing the interactions between medical devices and human tissues to prevent adverse reactions. They conduct laboratory tests, analyze data, and prepare technical documentation to meet regulatory standards. Biocompatibility Engineers play a crucial role in the development and approval of medical devices, working closely with regulatory agencies and product development teams.

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

To thrive as a Biocompatibility Engineer, you need a strong background in biomedical engineering or life sciences, with expertise in toxicology, materials science, and regulatory standards such as ISO 10993. Familiarity with laboratory testing protocols, risk assessment tools, and regulatory submission systems is typically required, and certifications like Certified Biological Safety Professional (CBSP) can be advantageous. Strong analytical thinking, meticulous attention to detail, and effective communication skills help in interpreting data, preparing reports, and collaborating with cross-functional teams. These competencies are crucial for ensuring medical devices are safe for human use and meet global compliance requirements.

What engineers make $500,000?

Senior engineers in specialized fields such as petroleum, aerospace, or software engineering can earn $500,000 or more annually, especially with experience, advanced skills, and bonuses. High-level roles often require advanced degrees, certifications, and leadership responsibilities within their industries.

What are some common challenges faced by Biocompatibility Engineers during the device development process?

Biocompatibility Engineers often encounter challenges in selecting appropriate materials that meet regulatory standards and ensuring compatibility with biological systems. They must navigate complex testing protocols and documentation requirements to demonstrate safety and effectiveness, which can be time-consuming and require cross-functional collaboration with regulatory, quality, and R&D teams. Additionally, staying updated with evolving international regulations and standards is vital, as non-compliance can delay product approvals and market entry.
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Biocompatibility Engineer jobs near you
Principal Quality Engineer - Design Assurance (NPD)

Principal Quality Engineer - Design Assurance (NPD)

Imperative Care

Campbell, CA • On-site

Full-time

Medical, Retirement, PTO

Posted 26 days ago

Job description

Title: Principal Quality Engineer - Design Assurance (NPD)
This position is based in our Campbell, California offices. This position is on-site, full-time.
Why Imperative Care?
Do you want to make a real impact on patients?
As part of our team at Imperative Care, you can help elevate care for patients suffering from stroke and other devastating vascular diseases. Every day, the technologies that we develop at Imperative Care directly impact people at the most vulnerable moments of their lives. Our focus is on the needs of the patient, and they come first in everything we do.
What You'll Do -
The Principal Quality Engineer is the subject matter expert who establishes processes, protocols, methods, and techniques to ensure compliance with quality standards and regulatory requirements during the development, manufacture and distribution of our medical device products. This role will involve leading sterilization and biocompatibility activities and/or overseeing the work of more junior team members or contracted testing laboratories, depending on focus area.
Product Development & Design Assurance
  • Lead development and execution of Design Assurance strategies and quality plans across the product development lifecycle to ensure compliance with applicable regulatory and internal quality requirements.
  • Provide strategic quality input to product development teams and ensure effective implementation of design controls, verification, validation, and transfer activities.
  • Establish and maintain quality engineering methodologies, procedures, and best practices supporting product realization and continuous improvement.
  • Review product requirements, design outputs, test protocols, and development documentation to ensure alignment with quality and regulatory expectations.
  • Utilize quality metrics and data analytics to identify trends, support decision-making, and drive proactive improvements.
Risk Management & Product Quality
  • Lead Risk Management activities in accordance with ISO 14971 and internal procedures.
  • Oversee development and approval of Risk Management Reports and support creation and maintenance of Use Risk, Design Risk, Process Risk, and benefit-risk documentation.
  • Evaluate quality and reliability impacts from design changes, complaints, CAPAs, nonconformances, supplier issues, and process modifications.
  • Conduct ongoing benefit-risk assessments throughout the product lifecycle and escalate unacceptable risks appropriately.
Sterilization, Microbiology & Biocompatibility (Subject Matter Expert)
  • Serve as the technical authority for sterilization, microbiology, contamination control, and biocompatibility activities, as applicable.
  • Develop, review, and approve sterilization validation protocols, reports, requalification strategies, and associated documentation.
  • Provide technical oversight of terminal sterilization modalities with emphasis on Ethylene Oxide (EO) sterilization.
  • Generate and maintain Biological Evaluation Plans (BEPs), assess testing outcomes, perform gap assessments, and determine biocompatibility testing strategies.
  • Interpret laboratory results and translate findings into product and regulatory decisions.
  • Serve as primary technical liaison with contract laboratories, manufacturing sites, suppliers, and development teams.
Supplier & External Partner Quality
  • Establish and maintain quality expectations with suppliers, contract manufacturers, and external laboratories through quality agreements and performance monitoring.
  • Support supplier qualification, audits, technical assessments, and remediation activities.
  • Drive supplier quality improvements through effective CAPA, SCAR, and risk mitigation activities.
Quality Systems & Regulatory Support
  • Support and enhance Quality Management System processes to maintain compliance with applicable regulations and standards.
  • Review and assess DCOs, CAPAs, complaints, NCMRs/NCRs, and change activities for quality and risk impact.
  • Prepare and support technical documentation for regulatory submissions, audits, inspections, and management reviews.
  • Support internal and external audits and serve as a technical representative during regulatory inspections.
Leadership & Organizational Influence
  • Act as a technical mentor and coach to Design Assurance, Quality Engineering, and cross-functional teams.
  • Provide technical leadership without direct authority across multiple functions and levels of the organization.
  • Develop and deliver training on design assurance, sterilization, biocompatibility, and quality system requirements.
  • Promote Quality Policy, Quality Objectives, and continuous improvement initiatives.
  • Ensure applicable personnel are trained on procedures, GMP requirements, and regulatory expectations.

What You'll Bring - minimum requirements for this role:
  • Bachelor's degree in Engineering, Life Sciences, Microbiology, Biomedical Engineering, or related technical discipline with 12+ years of progressive experience in medical devices or regulated industries; or equivalent combination of education and experience.
  • Master's degree preferred.
  • Experience supporting catheter-based, endovascular, neurovascular, or other Class II/III medical devices preferred.
  • Demonstrated technical leadership in Design Assurance and product development quality.

Required Technical Competencies
  • Deep expertise in medical device Design Controls and product development processes.
  • Strong knowledge of FDA Quality System requirements, including 21 CFR Part 820 / QMSR and ISO 13485.
  • Strong working knowledge of ISO 14971 risk management principles.
  • Advanced experience with CAPA, nonconformance management, and supplier quality systems.
  • Demonstrated experience supporting audits and regulatory inspections.

Preferred Specialized Expertise
  • Extensive experience with terminal sterilization methods (EO preferred).
  • Working knowledge of:
    • ISO 11135 - Ethylene Oxide Sterilization
    • ISO 11737 Series - Microbiological Methods
    • ISO 11138 Series - Biological Indicators
    • ISO 10993 Series - Biological Evaluation
    • AAMI TIR52
Professional Skills
  • Exceptional written and verbal communication skills.
  • Ability to influence and drive alignment across all organizational levels.
  • Strong analytical and problem-solving capabilities.
  • Ability to manage multiple priorities in a dynamic environment.
  • Proficiency with Microsoft Office and electronic quality systems.

Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.
Join Us! Imperative Care
Salary Range: $173,000 - 192,000 annually
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources.
The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.
Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.

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