Key Role: Senior Manufacturing Engineer
We are seeking a highly skilled Senior Manufacturing Engineer to join our team. This is an integral hire as we expand our business into new projects.
Main Responsibilities:
* Develop, optimize, and validate manufacturing processes to ensure high-quality products.
* Lead the implementation of NPI and product transfers into production.
* Collaborate with teams to refine machining processes and improve results using innovative solutions.
* Apply SPC tools for process monitoring and improvement.
* Implement process validation (IQ, OQ, PQ) to meet ISO 13485 and customer requirements.
* Use root cause analysis (8D, DMAIC, FMEA) to solve process inefficiencies and quality issues.
* Mentor junior engineers and foster a culture of innovation and continuous improvement.
* Drive improvements through Lean, Six Sigma, Kaizen, and OEE methodologies.
Requirements:
* 7+ years of experience in manufacturing engineering, preferably in the medical device industry.
* Expertise in process validation (IQ, OQ, PQ), SPC, and Lean Six Sigma.
* Leadership experience with cross-functional teams.
* Bachelor's degree in Mechanical, Manufacturing, Biomedical, or related field.
Preferrable Skills:
* CNC machining, precision manufacturing, metrology, and automation expertise.
* Lean Six Sigma certification (Green/Black Belt).