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Full Time Biocompatibility Jobs (NOW HIRING)

Neuralink

Systems & Process Engineer

Austin, TX · On-site

$145K - $165K/yr

Leading development of product characterizations and biocompatibility testing, DOEs, and validation ... What We Offer: Full-time employees are eligible for the following benefits listed below. * An ...

LeMaitre

Manager, Regulatory Affairs

Burlington, MA

$110K - $150K/yr

Familiar with biocompatibility, sterilization, packaging, shelf life and associated ISO standards. * Ability to work full-time onsite at company's facility. * RAC certified is a plus. EEO Statement ...

LeMaitre

Manager, Regulatory Affairs

Burlington, MA

$110K - $150K/yr

Familiar with biocompatibility, sterilization, packaging, shelf life and associated ISO standards. * Ability to work full-time onsite at company's facility. * RAC certified is a plus. In order to ...

Eurofins

GC-MS Scientist

Saint Louis, MO · On-site

Eurofins Medical Device Services is a global leader in analytical chemistry and biocompatibility ... Excellent full time benefits including * Comprehensive medical coverage, dental, and vision options

Eurofins Scientific

GC-MS Scientist

Saint Louis, MO

Eurofins Medical Device Services is a global leader in analytical chemistry and biocompatibility ... Excellent full time benefits including * Comprehensive medical coverage, dental, and vision options

LeMaitre

Manager, Regulatory Affairs

Burlington, MA · On-site

$110K - $150K/yr

Familiar with biocompatibility, sterilization, packaging, shelf life and associated ISO standards. * Ability to work full-time onsite at company's facility. * RAC certified is a plus. EEO Statement ...

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All JobsFull Time Biocompatibility Jobs

Full Time Biocompatibility information

See salary details

$41K

$115.4K

$214K

How much do full time biocompatibility jobs pay per year?

As of Jun 29, 2026, the average yearly pay for full time 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 the difference between Full Time Biocompatibility vs Full Time Regulatory Affairs Specialist?

AspectFull Time BiocompatibilityFull Time Regulatory Affairs Specialist
Required CredentialsBiocompatibility certifications, scientific degreesRegulatory certifications, science or law degrees
Work EnvironmentLaboratories, manufacturing plantsRegulatory agencies, corporate offices
Industry UsageMedical devices, implantsMedical devices, pharmaceuticals
Common Search IntentBiocompatibility testing, safety assessmentRegulatory compliance, submissions

Full Time Biocompatibility roles focus on testing and assessing the safety of medical materials, often requiring scientific certifications and laboratory work. In contrast, Full Time Regulatory Affairs Specialists handle compliance documentation and submissions to regulatory bodies, working more in office settings. Both roles are essential in the medical device industry but serve different functions related to product safety and approval processes.

More about Full Time Biocompatibility jobs
What cities are hiring for Full Time Biocompatibility jobs? Cities with the most Full Time Biocompatibility job openings:
What are the most commonly searched types of Biocompatibility jobs? The most popular types of Biocompatibility jobs are:
What job categories do people searching Full Time Biocompatibility jobs look for? The top searched job categories for Full Time Biocompatibility jobs are:
Full Time Biocompatibility jobs near you
Infographic showing various Full Time Biocompatibility job openings in the United States as of June 2026, with employment types broken down into 100% Full Time. Highlights an 80% In-person, and 20% Remote job distribution, with an average salary of $115,369 per year, or $55.5 per hour.
Principal Quality Engineer - Design Assurance (NPD)

Principal Quality Engineer - Design Assurance (NPD)

Imperative Care

Campbell, CA • On-site

Full-time

Medical, Retirement, PTO

Posted 19 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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