R&d Engineer

Johnson & Johnson Johnson & Johnson · Pharma · Zuchwil, Switzerland

R&D Engineer role focused on the design, development, and lifecycle support of orthopedic implants and instrumentation. Responsibilities include collaborating with cross-functional teams, developing product concepts, creating documentation for regulatory compliance (MDR, FDA), supporting manufacturing and testing, and ensuring adherence to quality and compliance standards within the medical device industry.

What you'd actually do

  1. Assists in the design and development of new implants and instrumentation and supports in-market products throughout their life cycle.
  2. Collaborates with design engineering, marketing, quality, supply chain, manufacturing, regulatory affairs, and Health Care Professionals (HCPs) to develop functional and design requirements and product concepts for new and existing products.
  3. Supports lead R&D engineers in developing conceptual models and drawing layouts, prototypes, verification and validation methods and reports, and required Design Control documentation.
  4. Contributes to documentation and Design Control activities to ensure compliance with MDR and FDA Design Control regulations and to support 510(k) submissions and/or IDE clinical studies.
  5. Contributes to designs with consideration for manufacturing and inspection processes.

Skills

Required

  • Bachelor’s degree in Engineering or a related discipline
  • Minimum 6 months of experience in the design and development of mechanical products

Nice to have

  • Mechanical Engineering
  • biomechanics
  • biology
  • anatomy
  • medical device regulations
  • GMP (Good Manufacturing Practices)
  • QSR (Quality System Regulation)
  • ISO quality requirements
  • GDP (Good Documentation Practice)
  • CAD software
  • manufacturing methods (especially machining)
  • mechanisms
  • materials
  • tolerancing
  • drafting standards
  • geometric dimensioning and tolerancing (GD&T)
  • designing medical devices
  • working in a machine shop environment
  • plastic injection molding design and manufacturing
  • Project management experience
  • Demonstrated creative design ability
  • Demonstrated ability to prioritize tasks and manage a varied workload
  • Demonstrated strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience
  • Good communication skills