Biocomp Engineer

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Job Description # Biocomp Engineer 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.
* 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.
* 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
* 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.

- ** Bachelor's degree with 5+ years of relevant industry experience**, or
** Master's degree with 3+ years of relevant industry experience**.
* 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.