Process Engineer – Medical Device

The Process Engineer is responsible for the development, improvement, control, and implementation of efficient, high-quality, and stable manufacturing processes for medical products, while adhering to strict quality and regulatory standards (such as ISO 13485, FDA).

Key Responsibilities:

- Develop new manufacturing processes – including writing specifications and creating work instructions.

- Continuously improve existing processes to reduce costs, enhance quality, and optimize time.

- Conduct root cause analysis for quality issues or line failures.

- Evaluate and implement new technologies (equipment, materials, automation).

- Write and maintain engineering documentation (SOPs, WIs, PFMEA, validation protocols).

- Conduct process validations (IQ/OQ/PQ) according to stringent quality standards.

- Support DMR/DHF preparation for products.

- Define KPIs and continuously monitor operational parameters.

- Perform statistical process analysis (SPC, DOE).

- Support quality and process improvement projects (Lean, Six Sigma).

Requirements:

- B.Sc. in Mechanical / Materials / Industrial / Biomedical Engineering.

- 2–5 years of experience as a process engineer in the medical device industry – mandatory (preference for experience with integrated mechanical-electronic-optical products).

- Proven experience in validations and familiarity with FDA and ISO 13485 regulations.

- Proficiency in statistical tools, data analysis, Excel, JMP, or Minitab.

- Experience with ERP systems (Priority / SAP) and document control systems (PLM).