Manager, Applications Engineering, R&d - Medtech

Johnson & Johnson Johnson & Johnson · Pharma · Cincinnati, OH +1

Manager, Applications Engineering, R&D – MedTech to support handheld medical devices business. Role is focused on creating and validating manufacturing processes, leading a team of engineers, and ensuring deliverables meet performance, quality, financial, and regulatory requirements.

What you'd actually do

  1. Serve as the functional manager for the Application Development Engineering Team, providing technical leadership and oversight across a diverse set of manufacturing and assembly techniques.
  2. Establish and reinforce engineering best practices, standards, and development methodologies related to scale up of medical device manufacturing processes.
  3. Drive technical excellence and efficiency with associated validation activities such as IQ/OQ/PQ, Gage R&Rs, Control Plans, PMFEAs, Process Characterization (DOEs) and Process Capability analysis (Ppk/Cpk).
  4. Provide technical guidance, creative strategies and problem-solving support for complex application development challenges for the business.
  5. Act as a technical escalation point for development issues impacting financials, quality, safety, or performance.

Skills

Required

  • People leadership
  • Technical leadership
  • Manufacturing process development
  • Validation activities (IQ/OQ/PQ, Gage R&Rs, Control Plans, PMFEAs, Process Characterization, Process Capability analysis)
  • Risk management (FMEA)
  • Verification/validation support
  • Statistical analysis
  • Design controls
  • Quality and regulatory system requirements
  • Continuous improvement
  • Modeling and simulation techniques

Nice to have

  • Experience with handheld medical devices
  • Experience with surgical staplers, clip appliers, trocars, and sealing devices
  • Experience with minimally invasive and open surgical procedures
  • Experience with Design to Value principles

What the JD emphasized

  • medical device manufacturing processes
  • NPD development activities
  • design controls and quality / regulatory system requirements