Senior Mechanical Engineer – Biocompatibility, Packaging, Sterilization

Responsibilities

• Provide end‑to‑end ownership of biological safety, materials evaluation, sterilization strategy, and packaging development across the full product lifecycle
• Author and approve Biological Evaluation Plans (BEPs), Biological Evaluation Reports (BERs), toxicological assessments, and supporting documentation
• Develop and maintain sterilization strategies for implantable devices, including EO, gamma, or other validated modalities
• Lead packaging material selection, sterile barrier system development, and packaging design improvements
• Conduct materials assessments, including evaluation of polymers, metals, adhesives, coatings, and surface treatments
• Work closely with cross‑functional teams to ensure alignment across programs and provide expert input for global regulatory submissions

• Bachelor’s degree or higher in Materials Science, Mechanical Engineering, Biomedical Engineering, or related field
• Strong understanding of biocompatibility, sterilization, materials science, and packaging principles
• Excellent written and verbal communication skills, with the ability to convey complex technical information clearly
• Demonstrated problem‑solving ability and experience conducting detailed engineering investigations
• Experience working within a QA‑controlled, regulated medical device environment
• Collaborative, team‑oriented mindset with the ability to work across global functions