New Product Introduction (NPI) & Process Development

• Support new product industrialization from concept through production launch.
• Collaborate with R&D teams to incorporate Design for Manufacturing (DFM) and Design for Assembly (DFA) principles into product designs.
• Develop and optimize manufacturing processes to achieve quality, efficiency, and cost targets.
• Define critical process parameters and establish process controls.

Tooling, Fixtures & Equipment Development

• Design, develop, and evaluate manufacturing jigs, fixtures, and process aids for prototype and production builds.
• Apply Poka-Yoke (error-proofing) concepts to reduce process variation and prevent defects.
• Work with the Equipment and Automation team to define Process Input Requirements (PIR) and manufacturing equipment specifications.

Process Validation & Qualification

• Support IQ, OQ, and PQ execution for manufacturing equipment and processes.
• Establish robust process windows to ensure consistent product quality and regulatory compliance.

Risk Management & Continuous Improvement

• Conduct process risk assessments and FMEA activities to identify and mitigate manufacturing risks.
• Investigate process issues and implement effective corrective and preventive actions.
• Drive continuous improvement initiatives to improve yield, efficiency, ergonomics, and product quality.

Cross-Functional Collaboration

• Work closely with Quality, Manufacturing, Supply Chain, Technical, Process and Global Project Teams throughout NPI projects.
• Provide technical support during pilot builds, process transfers, and production ramp-up activities.
• Support Life Cycle changes activities between global sites.

• Bachelor's or Master's Degree in Mechanical Engineering, Mechatronics Engineering, Biomedical Engineering, or a related discipline.
• Experience in NPI, Process Engineering, Manufacturing Engineering, or Product Industrialization.
• Experience in medical device manufacturing is an advantage.

Technical Skills

• Strong understanding of manufacturing processes such as:
  • Assembly processes
  • Ultrasonic welding
  • UV bonding and curing
  • Testing and inspection systems
  • Semi-automated manufacturing equipment
• Familiar with:
  • DFM/DFA
  • FMEA
  • DOE
  • Process Capability Studies
  • Statistical analysis tools
  • Lean Manufacturing principles

Personal Competencies

• Strong problem solving and analytical skills
• Able to manage multiple projects in a fast-paced NPI environment.
• Effective communication and stakeholder management skills.
• Team-oriented with a proactive and hands-on approach.