Senior Mechanical Engineer

A Class III medical device company is seeking a talented Mechanical/Biomedical/Material Engineer to join the Engineering team, leading multiple processes and a complex product through the transition to manufacturability.

Responsibilities

Lead New Product Introduction (NPI) processes, including transfer from R&D to production.

Optimize manufacturing processes, including the design and development of production equipment and jigs.

Writing manufacturing documentation

Provide production floor support through effective problem-solving and root cause analysis.

Collaborate with external suppliers and subcontractors to ensure quality, efficiency, and compliance.

Lead equipment and process qualifications (IQ, OQ, PQ)

Lead and implement engineering changes (ECOs) to improve design and manufacturing outcomes

Writing test protocols and reports.

Mechanical, Biomedical, or Materials Engineering with a strong mechanical orientation.

3-5 years of experience (medical device industry- an advantage).

Acquittance quality assurance and regulatory standards.

Proven hands-on expertise in process development.

Proficiency in SolidWorks (and PDM).

Analytical skills.

Good written/verbal communication skills.

Strong interpersonal skills with the ability to collaborate effectively across multidisciplinary teams