V&V Biocompatibility Specialist

Job Description

Job Description

Job Title: product development specialist

Job Description

Join our team as a V&V Biocompatibility Specialist where you will engage in vital Verification and Validation (V&V) activities for medical devices. Your role will encompass planning, execution, and documentation, ensuring that V&V activities are seamlessly integrated into the product development lifecycle.

Responsibilities

• Develop V&V protocols, test plans, and reports aligned with design control and risk management processes.
• Ensure compliance with applicable standards.
• Manage external labs and contractors performing biocompatibility, environmental, and performance testing.
• Support regulatory submissions by providing V&V documentation and addressing regulatory queries.
• Identify and mitigate risks related to product safety, performance, and usability.
• Maintain traceability between requirements, testing, and risk analysis documentation.
• Participate in design reviews and provide feedback on testability and compliance.
• Support technology transfer from R&D to manufacturing through validated processes.
• Execute biological safety evaluations of medical devices, including gap assessment activities.
• Ensure compliance with product documentation regarding Biocompatibility, Manufacturing Processes, Sterilization, Packaging, and/or Cleaning Validation information.
• Compile, write, and review Biocompatibility Test Plan, Test Report, and Risk Assessment of medical devices in accordance with regulatory requirements.
• Develop Toxicology/Biocompatibility Risk Assessment Strategies and collaborate on the Toxicological Risk Assessment report.
• Collaborate with associates of diverse technical backgrounds and partners with Regulatory Affairs, Quality Engineering, Manufacturing, Packaging, and Project Teams to achieve desired project outcomes.

Essential Skills

• Biocompatibility experience
• Experience in Medical Device Product Development/R&D.
• Proficiency in Sterilization and Technical Writing.
• Knowledge of GMP, Toxicology, and relevant standards.
• Experience with FDA regulatory interactions.

Additional Skills & Qualifications

• BS degree in scientific disciplines such as material science, toxicology, chemistry, biology, or similar.
• 1-2 years of experience in the Medical Device Industry.
• Familiarity with relevant standards.

Work Environment

This role offers a flexible remote/hybrid work environment. We provide a supportive culture that encourages creativity and professional development. Our benefits package includes paid parental leave, in-house training, and professional development opportunities. We are committed to a culture of surgical innovation, focusing on providing the best-in-class treatment for patients through collaborative efforts and cutting-edge technology.

This is a Permanent position based out of Jacksonville, FL.

The pay range for this position is $70000.00 - $85000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Full benefits, medical, dental, 401k

This is a fully onsite position in Jacksonville,FL.

This position is anticipated to close on Sep 22, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.