Process Engineer II – Medical Device Manufacturing

About the role

Biomerics is seeking a Process Engineer II to drive process stability, yield improvement, and defect reduction in a regulated medical device manufacturing environment focused on complex catheter assembly and testing.

Key responsibilities

• Provide technical support for catheter mechanical assembly and electrical testing processes.
• Lead initiatives to improve yield and reduce scrap.
• Perform data analysis on yield, defects, work‑in‑process, operators, and stations.
• Implement process control, standardization, and systematic improvements.
• Support validation activities including IQ, OQ, PQ, TMV, and SV.
• Collaborate cross‑functionally with production, quality, and engineering teams.

Required profile

• Bachelor’s degree in Mechanical, Biomedical, Electrical Engineering or a related field.
• 3–5+ years of experience in medical device or regulated manufacturing.
• Experience with catheter or precision assembly processes (preferred).
• Strong data‑analysis capability using Excel and Power BI.
• Knowledge of FDA and ISO 13485 validation and regulatory requirements.

Required skills

• Excel
• Power BI

What we offer

• A collaborative, growth‑oriented environment focused on innovation and manufacturing excellence.
• Opportunities to make a tangible impact on patient lives through advanced medical technologies.
• Commitment to core values such as integrity, teamwork, and empowerment.