Job DescriptionPosition Summary We are seeking a Biocompatibility Engineer II to join our team. As a member of the biocompatibility team, you will help ensure patient safety by contributing to the biological and toxicological evaluations of medical devices, materials, and processes. You will work closely with cross-functional teams to comply with global regulatory standards such as ISO 10993.
You will leverage your understanding of the medical device biocompatibility field to provide guidance throughout the product development cycle, interpret regulatory requirements, and support the biocompatibility strategy. Using your analytical skills, you will review scientific data, identify gaps, and recommend risk mitigation strategies.
This position will be pivotal in supporting regulatory compliance, quality engineering strategies, and design history file (DHF) remediation aligned with medical device regulations and standards such as EU MDR, FDA 510(k), ISO 13485, ISO 10993, ISO 18562, and ISO 14971.
Essential Duties & Responsibilities- Conduct biocompatibility assessments and evaluations in accordance with biological evaluation standards and regulatory requirements.
- Collaborate with cross-functional teams to support multiple projects and meet schedules as defined by the larger project team.
- Evaluate and reviews biocompatibility test data, protocols, and results.
- Assist with regulatory submissions and address biological safety concerns in design meetings.
- Stay informed of external standards and industry requirements for medical device biological safety, which is not limited to internal and external gap assessment evaluations for standards that govern both the biocompatibility and medical device reprocessing procedures.
- Contribute to the development and implementation of biocompatibility strategies (Experimental paradigm development).
- Collaborate closely with external test labs to ensure validity and appropriateness of test methodology, conduct, and reporting.
- Write biological evaluation plans, reports, and other biocompatibility-related materials.
- May participate in reviewing and improving policies, processes, and procedures pertinent to Biocompatibility Team.
- Maintain positive, cooperative, and timely communication with all levels of employees, customers, contractors, and vendors.
Knowledge & Skills- Fundamental understanding of ISO 10993 standards, biomaterials, toxicological risk assessment, extractable and leachable analysis, medical device manufacturing processes, and biocompatibility assessment methodology.
- Proficient in MS Office and excellent written and verbal communication skills.
- Ability to work in a fast-paced, changing environment, prioritize tasks, and meet deadlines.
- Communicate results, risks, and rationale with precision and in a timely manner to drive alignment on scope, expectations, and decisions, supporting on-time execution and adherence to project timelines while ensuring defensible biological safety conclusions.
- Organized and detail-oriented with strong follow-up skills and experience in a cross-division business unit.
Minimum Qualifications, Education & Experience - Must be at least 18 years of age.
- Bachelor's degree in chemical or biomedical engineering, or related field, from an accredited college or university is required.
- 2+ years of Industry (Medical Devices) experience with a Bachelor.
- A Master's Degree or PhD in a relevant field may substitute for industry experience.
Work Environment- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
- Typically requires travel less than 5% of the time
This role is based remotely; the incumbent may be remote in any state other than Colorado; California; Connecticut; Montana, Maine or New York.
