Opportunity to work with leading Medical Device Company- Contract opportunity with benefits,
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 multi-functional 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 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 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 ‘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.
Qualifications and Work Experience 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.
World's leading medical technology companies and offer a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine, which help improve patient and hospital outcomes.
Role: Manufacturing Process Engineer
Apply for this job now.