Project Engineer, Product Development

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

Permanent