Demo

Project Engineer, Product Development

Tephra Inc.
Warsaw, IN Full Time
POSTED ON 1/20/2025
AVAILABLE BEFORE 4/7/2025

Description :

This profile will require the candidate identified to take up role within R&D department of Orthopaedic Medical Device major and provide consulting services in Product Development Engineering with some level of Project Management. The candidate should be experience in end-to-end product development and must have Project Management background.

Responsibilities :

  • Conceptualize new design and develop new products for Joints Reconstruction Surgery
  • Develop improvements and modifications to current products
  • Understand and follows the New Product Development process accurately
  • Coordinate with surgeons and cross functional groups of client organization to gather VOC for new product development. Define and develop product requirements and concepts from VOC
  • Generate product models, concept layouts and drawings using CAD software. Apply GD&T appropriately.
  • conceive, plan, and implement solutions to technical problems requiring unconventional approaches, new designs, and equipment and process development
  • Ensure Design Verification and Validation is performed to demonstrate safety and efficacy of new design
  • Directly interact with surgeons and all levels of client's management, external experts and vendors
  • Provide updates to company management regarding work performed & deliverables
  • Primarily work hands-on with instruction or supervision of others secondary to own technical work when needed.
  • May need to lead sub-projects and assignments
  • Assume responsibility for own and team's commitments & delivering to agreed timescales per project deadlines
  • Create and manage Engineering Change Orders if required
  • Use expertise to improve operational efficiencies and meet compliance requirements and operate within their budget
  • Make use of the offshore team, based in various locations, with prior approval of the concerned line manager(s)

Qualifications :

Must have qualifications :

  • Bachelor's Degree in engineering (Biomedical Engineering or Mechanical Engineering) or related discipline
  • A minimum of 4 years of experience in product development or design control of mechanical products
  • A minimum of 1-year Project Management experience and / or leading technical projects
  • Demonstrated understanding of various types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and GD&T
  • Experience working in Medical Device regulations, including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations) and ISO (International Organization for Standardization) quality requirements
  • Strong design quality experience with a proven track record in design verification / validation, process verification / validation, and design / process failure modes and effects analyses
  • Willing to work with cadavers and within an Operating Room setting
  • Proficiency utilizing the MS Office Suite (Word, Excel, and PowerPoint)
  • Preferred Qualifications :

  • Knowledge of CAD software (NX, Creo or Solidworks)
  • Experience with implantable medical devices
  • Experience with Plastic Injection Molding
  • Knowledge with 510(k) submission process and regulation control
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