NPI Mechanical Engineer

A leading medical device company is looking for an NPI Mechanical Engineer to lead new product introduction processes and support the transfer of complex medical products from R&D to manufacturing.

The company develops advanced catheter-based mechanical circulatory support technologies, including miniaturized pump systems designed for demanding cardiovascular indications. This is a hands-on engineering role with broad impact on manufacturability, production readiness, process optimization, quality, and regulatory compliance.

Responsibilities

• Lead New Product Introduction processes, including transfer from R&D to manufacturing.

• Optimize manufacturing processes for complex medical device products.

• Design and develop production equipment, fixtures, and jigs.

• Write and maintain manufacturing documentation, work instructions, test protocols, and engineering reports.

• Provide hands-on engineering support to the production floor.

• Collaborate with R&D, Production, Quality, and Operations teams to implement process improvements.

• Work with external suppliers and subcontractors to ensure quality, efficiency, and compliance with requirements.

• Lead equipment and process qualification activities, including IQ, OQ, and PQ.

• Lead and implement Engineering Change Orders to improve design and manufacturing outcomes.

• Write test protocols, execute tests, analyze results, and document conclusions.

• Support continuous improvement initiatives related to yield, quality, reliability, cost, and manufacturability.

Required Qualifications

• B.Sc. in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or a related field with a strong mechanical orientation - must.

• 3–5 years of relevant engineering experience - must.

• Proven hands-on expertise in process development - must.

• Experience with quality assurance and regulatory standards - must.

• Proficiency with SolidWorks and PDM - must.

• Strong analytical skills and ability to solve complex engineering and manufacturing problems.

• Strong written and verbal communication skills.

• Strong interpersonal skills and ability to collaborate effectively in multidisciplinary teams.

JOB NO. 500386