Project Engineer, Product Development
: Job Details :

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