Senior Mechanical Engineer – Biocompatibility, Packaging, Sterilization

Saluda Medical

Senior Mechanical Engineer focusing on biocompatibility, sterilization, and packaging for medical devices. Collaborating with cross-functional teams to meet regulatory standards and ensure patient safety.

Posted 6/14/2026full-timeMinnetonka • Minnesota • 🇺🇸 United StatesSeniorWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

biological safetymaterials evaluationsterilization strategypackaging developmentBiological Evaluation PlansBiological Evaluation Reportstoxicological assessmentsmaterials assessmentsbiocompatibilitypackaging principles

Soft Skills

written communicationverbal communicationproblem-solvingcollaborationteam-oriented mindset

Certifications & Qualifications

Bachelor’s degreeMaster’s degree

Industry Keywords

QA-controlled environmentregulated medical deviceimplantable devicessterile barrier systemglobal regulatory submissions

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

Health insurance
Retirement plans
Flexible work arrangements
Professional development