Project Engineer, Product Development
Apply NowCompany: Tephra Inc.
Location: Warsaw, IN 46580
Description:
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
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