Process Engineer

An innovative, pioneering MedTech company specializing in the design, development, and clinical manufacturing of life-saving implantable medical devices. The company is a global leader in advanced, minimally invasive stent-graft delivery systems engineered to treat complex aortic arch pathologies.

Operating under rigorous global regulatory and quality standards, the organization delivers cutting-edge medical technologies deployed across premier healthcare institutions worldwide.

Located in the Sharon / Central region (approx. 10 minutes walk from the train station), operating on a hybrid work model with 1 day WFH per week.

Role Description-

• Serving as a Senior Process & Manufacturing Engineer, driving production process engineering, manufacturing support, process optimization, and line industrialization for complex implantable medical devices.

• Dedicating ~80% of the role to manufacturing engineering: troubleshooting, root cause analysis (RCA), implementing corrective/preventative actions (CAPA), and optimizing yield and cycle times on the production floor.

• Allocating ~20% of the role to hands-on mechanical CAD design: designing custom jigs, fixtures, tooling, and dedicated manufacturing equipment.

• Leading process development, implementation, and formal process validation activities (IQ / OQ / PQ) in compliance with medical device standards.

• Authoring clear, controlled technical documentation, including standard operating procedures (SOPs), manufacturing batch records, engineering drawings, and validation reports.

• Collaborating cross-functionally and hands-on with Cleanroom Production Operators, R&D Engineers, Quality Assurance, and Regulatory Affairs.

Requirements-

• B.Sc. in Mechanical Engineering, Biomedical Engineering, or an equivalent technical discipline – Mandatory

• 10+ years of hands-on experience in Process Engineering, Manufacturing Engineering, Industrialization, or Mechanical Design – Mandatory

• 3+ years of experience in Mechanical CAD Design and detailed technical drafting (preferably SolidWorks) – Mandatory

• Proven background in designing Fixtures, Jigs, Custom Tooling, or Production Assembly Equipment – Mandatory

• Extensive experience with Process Development, Transfer to Production, and Process Validation (IQ/OQ/PQ) – Mandatory

• Strong hands-on background in Manufacturing Floor Support, Troubleshooting, and Root Cause Analysis (RCA) – Mandatory

• Proven capability in authoring controlled technical and manufacturing documentation – Mandatory

• Highly hands-on approach with strong motivation to work directly on the production line with operators, tools, and hardware – Mandatory

• Fluent, high-level English (both written and verbal) – Mandatory

• Experience within the Medical Device (Class II / Class III / Implantables / Catheters / Stents) industry – Significant Advantage