- 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 Continuous improvement team to develop the cell layout and process flow for the Triathlon Globalization Femur utilizing lean six sigma tools.
- Create and release QMS documentation and Preventive Maintenance schedule for multiple manufacturing equipment including CNC milling, Bead Blast, Laser engraving, Coordinate Measuring Machine (CMM), robotic tending equipment, etc.
- Create documentation in Client’s validation system for Master Validation Plan, Process Qualification, Factory Acceptance Test, Site Acceptance Tests, Equipment Qualification, and Measuring System Analysis (GR&R)
- Execute equipment validations, process qualification, and GR&R studies.
- 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
- Manage suppliers and resolve supplier issues, particularly for Supplier Innovation role.
- Manage small to medium project timelines.
- 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
- Perform dimensional and visual inspection to blueprint and guide sheets using CMM, standard gages, customized gages, if required.
- 3+ 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 experience managing suppliers and resolving supplier issues, particularly for Supplier Innovation role.
- Demonstrated experience managing small to medium project timelines.
- Ability to work independently with low supervision.
- Ability to meet project milestones and deadlines on time.
- Demonstrated familiarity with theory and practical application of ‘Geometric Dimensioning & Tolerancing’ (GD&T)
- 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
- 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: Bachelor’s degree in a science degree, preferably Engineering.
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