We are seeking an experienced Senior Process Development Engineer to join our team.
This critical role will focus on designing, developing, and optimizing manufacturing processes for innovative medical devices, ensuring compliance with industry regulations
The ideal candidate will drive process improvements, lead technical projects, and act as a mentor to junior team members, contributing to the delivery of repeatable manufacturing process and in turn products at the highest quality and efficiency standards.

QUALIFICATIONS

• Bachelor’s degree in engineering (e.g., Mechanical, Biomedical, or related field).
• 5+ years of experience in process development in the medical device industry.
• Demonstrated expertise in developing and scaling manufacturing processes for regulated environments.
• Hands-on experience with process validation (IQ, OQ, PQ) and statistical process control (SPC).

SKILLS

• Strong technical background and capabilities.
• Working knowledge of six sigma and/or lean engineering principles with a proven track record in use and delivery of results.
• In-depth knowledge of medical device regulations and standards, including ISO 13485 and FDA cGMP.
• Strong proficiency in data analysis tools and techniques (DOE, Minitab, etc.).
• Experience in manufacturing technologies such as injection moulding, laser processing, automation, or additive manufacturing.
• Strong project management skills with a proven ability to lead cross-functional teams.
• Excellent verbal and written communication skills, including technical documentation.
• Certification in Lean Six Sigma (Green Belt, Black Belt) or equivalent.
• Experience with Design for Manufacturability (DFM) and Design for Assembly (DFA).
• Familiarity with cleanroom operations and sterilization processes (e.g., EtO, gamma).