Senior Process Engineer – Medical Devices

Job Title: Senior Process Engineer – Medical Devices

Location:

Employment type:

Job Summary:

Process Engineer Trainer

Key Responsibilities:

• Lead the design, development, and validation of manufacturing processes for medical devices in

  compliance with FDA, ISO 13485, and GMP regulations

  .
• Drive process improvements to enhance product quality, reduce cost, and improve efficiency using Lean and Six Sigma methodologies.
• Support

  New Product Introduction (NPI)

  by developing scalable and validated manufacturing processes from concept through commercialization.
• Collaborate with R&D, Quality, and Operations teams to ensure seamless technology transfer.
• Lead root cause investigations, implement CAPAs, and ensure corrective actions are effective and sustainable.
• Develop and maintain process documentation, including work instructions, PFMEA, process flow diagrams, and control plans.
• Provide technical mentorship to junior engineers and manufacturing teams.
• Manage and support equipment selection, installation, qualification

  (IQ/OQ/PQ)

  , and maintenance strategies.
• Ensure compliance with industry standards, safety regulations, and regulatory requirements across all processes.
• Lead cross-functional projects focusing on yield improvement, scrap reduction, and cycle time optimization.

Qualifications & Experience:

• Bachelor’s or Master’s degree in Mechanical, Biomedical, Industrial, Chemical, or related Engineering field.

• 10+ years of proven process engineering experience

  in the

  medical device industry

  .
• Strong knowledge of

  ISO 13485, FDA 21 CFR Part 11/Part 820, and GMP requirements

  .
• Hands-on experience with

  process validation (IQ, OQ, PQ), equipment qualification, and test method validation

  .
• Expertise in Lean Manufacturing, Six Sigma, DOE, and statistical analysis tools.
• Proven track record in

  new product introduction, process scale-up, and technology transfer

  .
• Strong problem-solving skills with experience in root cause analysis and risk management.
• Excellent communication, leadership, and cross-functional collaboration skills.

Preferred Skills:

• Six Sigma Green/Black Belt certification.
• Experience with automated manufacturing systems, robotics, or advanced manufacturing technologies.
• Knowledge of polymer processing, assembly techniques, or packaging processes for medical devices.
• Familiarity with software tools such as Minitab, SolidWorks, or similar engineering applications.