- Support the development and introduction of new orthopedic products. Work extensively with Product Development, Quality and Operations to take a product from design concept through production ramp up.
- Participate in multifunctional teams, led by a Project Manager and be responsible for defined project deliverables.
- Manage new equipment installation activities with the facilities team to deliver the work on schedule and budget.
- Work closely with the project team to gather equipment installation requirements and act as the point of contact for the facilities team.
- eview bids from contractors to ensure project is on budget.
- Maintain equipment installation schedule by monitoring project progress; coordinating activities; resolving problems in collaboration with the facilities team and Project Manager.
- Act as a point of contact for the facilities team for the Customs, R&D Prototypes, Process Engineering, Advanced Operations, Advanced Technology, and Scorpio cell relocation activities.
- Work closely with the Continuous improvement team to develop the cell layout and process flow for the Triathlon Globalization Femur utilizing lean six sigma tools.
- Create documentation in Company’s validation system for Master Validation Plan, Process Qualification, Factory Acceptance Test, Site Acceptance Tests, Equipment Qualification, and Measuring System Analysis (GR&R)
- Manage Engineering Change Notices for new products from creation to final approval
- Operate within Company’s quality system to produce documentation such as process validations, equipment qualifications, dynamic control plans, inspection plans and standard operating procedures
- Operate within Company’s ‘New Product Development Process’ [NPDP], to build robust processes through involvement in ‘Design for Manufacturability’ and ‘Lean Manufacturing’ initiatives
- Utilize Six Sigma process tools such as ‘Define, Measure, Analyze, Improve, Control’ (DMAIC), ‘Failure Modes & Effects Analysis’ (FMEA), ‘Design of Experiments’ (DOE), Gage Repeatability & Reproducibility’ (Gage R&R), ‘Statistical Process Control’ (SPC), capability analysis as required
- Provide input to Capital Equipment Requests (CERs)
- Create and execute Process Qualification protocols as required.
- 5+ years of engineering experience in the Medical Device, or similar, quality regulated industries
- Demonstrated fundamental understanding of manufacturing processes, e.g. casting, forging, CNC machining, coating, etc.
- Demonstrated familiarity with theory and practical application of ‘Geometric Dimensioning & Tolerancing’ (GD&T)
- Demonstrated experience with a parametric CAD design package, with a strong preference for ProE.
- Demonstrated proficiency in Microsoft Outlook, Microsoft Project, Microsoft Visio and Microsoft Office applications
- Demonstrated interpersonal, communication and presentation skills. Must be comfortable presenting at department level meetings
- Demonstrated experience dealing with suppliers and resolving supplier issues, particularly for Supplier Innovation role
- Must be challenged by a team-based environment which places a high degree of emphasis on accountability for customer satisfaction, cost reduction and quality/GMP compliance
- Education and Special Training Required:
- Bachelors degree in a science, preferably Engineering.
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