Biocomp Engineer

Biocomp Engineer Job#: 3058204

Job Description:

Biocomp Engineer
- Research Senior II

Location:

Onsite Jacksonville, FL

Job Summary We are seeking an experienced Biocomp Engineer
- Research Senior II to support biological safety, product remediation, and research activities for orthopedic medical devices. This role will be heavily involved in the transfer of products from one manufacturing facility to another, with responsibility for biological evaluation planning, biological safety risk assessments, material assessments, and coordination with external laboratories.

The engineer will partner closely with R&D, manufacturing, quality, regulatory, process engineering, and other cross-functional teams to ensure biological safety requirements are appropriately evaluated, documented, and addressed throughout the product transfer and remediation process.

Key Responsibilities Support the transfer of orthopedic products from one facility to another, including biological safety and regulatory documentation.

Develop, review, and maintain Biological Evaluation Plans (BEPs).Develop and support Biological Evaluation Reports (BERs) and biological safety risk assessments.

Conduct biocompatibility assessments in accordance with ISO 10993 and applicable medical device requirements.

Perform material assessments, including evaluation of Substances of Very High Concern (SVHC) and Carcinogenic, Mutagenic, Reprotoxic and Endocrine-Disrupting (CMR-ED) substances.

Develop biological testing strategies and determine appropriate testing requirements for orthopedic products.

Coordinate testing and technical activities with external Contract Research Organizations (CROs) and laboratories.

Develop, review, and approve technical documentation, including study protocols, reports, risk assessments, and supporting scientific rationale.

Identify and support remediation activities for existing orthopedic medical device products.

Provide biological safety content and scientific rationale for technical and regulatory documentation.

Present scientific, preclinical, and technical information to cross-functional stakeholders.

Support project updates, technical reviews, and data presentations.

Collaborate across R&D, design, manufacturing, quality, regulatory, process engineering, and site teams.

Participate in meetings across multiple global time zones, including the U.S. Eastern time zone, China, and Costa Rica.

Required Qualifications Bachelor's degree in a relevant scientific or engineering discipline such as:

Biomedical Science Biology Toxicology Materials  Science Biomedical Engineering Related scientific or engineering discipline

Bachelor's degree with 5+ years of relevant industry experience, or Master's degree with 3+ years of relevant industry experience.
3+ years of medical device R&D experience involving biological safety and/or biocompatibility risk assessment.

Strong working knowledge of ISO 10993 and biological evaluation requirements for medical devices.

Experience developing or supporting BEPs, BERs, and biological safety risk assessments.

Experience evaluating materials and biological safety considerations for regulated medical devices.

Strong scientific and technical writing skills.

Ability to interpret complex scientific information and communicate findings clearly to technical and non-technical stakeholders.

Ability to independently assess technical issues, identify solutions, and execute against project timelines.

Strong cross-functional collaboration and stakeholder-management skills.

Preferred Qualifications Master's degree in a relevant scientific or engineering discipline.

Experience with orthopedic or implantable medical devices.

Experience supporting product transfers, product remediation, or manufacturing site transfers.

Experience conducting SVHC, CMR-ED, or similar chemical/material assessments.

Experience coordinating testing with external CROs and laboratories.

Experience supporting regulated medical device product development and regulatory submissions.

Project management experience involving cross-functional technical teams.

Work Environment & Schedule This position is onsite in Jacksonville, Florida, where the engineer will have direct access to the project team and technical resources. Because the position supports global teams, working hours may occasionally vary to accommodate meetings across U.S. Eastern, China, and Costa Rica time zones.

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