Description
We are looking for an experienced, hands-on Mechanical Engineer to join our growing Engineering team.
In this role, you will lead engineering and manufacturing processes, support New Product Introduction (NPI) and technology transfer activities, and contribute to the transition of complex medical devices from development to manufacturing.
This is an opportunity to take an active role in scaling up manufacturing operations, working closely with multidisciplinary teams to improve product quality, manufacturability, and production efficiency.
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.
Reports to
Team Leader
Requirements
- B.Sc. in Mechanical, Biomedical, or Materials Engineering, with a strong mechanical engineering background – Must.
- 3–5 years of experience in the medical device industry – Must.
- Proven hands-on experience in manufacturing process development – Must.
- Proficiency in SolidWorks and PDM systems – Must.
- Familiarity with quality management systems and regulatory requirements applicable to the medical device industry.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- Strong interpersonal skills and ability to collaborate effectively across multidisciplinary teams.
Advantages
- Experience in technology transfer from R&D to manufacturing (Tech Transfer).
- Experience in New Product Introduction (NPI) processes and manufacturing scale-up.