Manager, Advanced Manufacturing Engineer - MedTech

Are you ready to play a key role in shaping the future of advanced manufacturing in the Med Tech space? We are seeking a Manager, Advanced Manufacturing Engineering (AME) to drive product and process development for critical medical device components. This is a unique opportunity to work in a contract manufacturing environment where innovation meets execution—supporting world-class OEMs and scaling best-in‑class solutions.

• Lead the design, development, and optimization of manufacturing processes for precision medical device components (Class I, II, III).
• Drive Design for Manufacturability (DFM) and ensure smooth design transfer from customer R&D to our production floor.
• Develop advanced tooling, fixtures, and automation strategies to enhance process capability and efficiency.
• Partner with customers on process validation, capability studies, and technical discussions to align manufacturing solutions with device requirements.
• Perform cost analysis, capital planning, and support make/buy recommendations to ensure scalability and profitability.

• Serve as the technical SME for internal teams and customer-facing discussions, presenting process capabilities and validation strategies.
• Collaborate closely with Quality, Operations, and Regulatory teams to ensure compliance with medical device standards.
• Lead root cause analysis, corrective actions (CAPAs), and continuous improvement initiatives to exceed customer expectations.
• Contribute to long-term strategy for advanced manufacturing technologies and future team development.

• Author and execute IQ/OQ/PQ protocols for equipment and process validation.
• Ensure all activities align with FDA 21 CFR Part 820, ISO 13485, and other applicable regulations.
• Maintain detailed documentation to support design controls and customer audits.

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related technical field (Master’s preferred).
• 8–10+ years in medical device manufacturing or process development, ideally within a contract manufacturing or component-level environment.
• Expertise in:
  • Medical device regulatory standards (FDA, ISO 13485, EU MDR)
  • Validation (IQ/OQ/PQ) and process capability analysis
  • CAD tools (Solid Works, Creo)
  • Statistical tools and methodologies (DOE, Minitab, Six Sigma)

• Experience working with OEMs on component-level manufacturing for Class II/III devices.
• Hands‑on knowledge of processes such as precision machining, injection molding, laser welding, or cleanroom assembly.
• Familiarity with design controls and PLM systems (Agile, Windchill).
• Six Sigma Green/Black Belt or CQE certification preferred.
• Exceptional communication skills and ability to influence internal and external stakeholders.

• Opportunity to impact Med Tech innovation at a component level, supporting top global OEMs.
• Startup‑like agility within a growing organization backed by strong industry presence.
• Future leadership potential:
  Build and lead an engineering team as the business scales.
• Competitive compensation and benefits package.

EOE/M/F/D/V