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
Warsaw, Indiana