- 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)
- 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)
- 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
District Mgr, Petsense - Warsaw, United States - Tractor Supply
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.
Responsibilities:
Must have qualifications:
Preferred Qualifications: