Senior Engineer, Process Engineering
TOP medical device company- Contract opportunity benefits offered- may go permanent
Position Summary & Responsibilities
• 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 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 Stryker’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 gauges and comparators
• Demonstrated interpersonal, communication and presentation skills. Must be comfortable presenting at department level meetings
Qualifications and Work Experience Required: The Intermediate Project/Validation Engineer role is a challenging position that will employ a variety of tools and techniques to analyze information collected by the system itself and by products used to monitor the system. The Intermediate Project Engineer works closely with Project leads and Technical SME’s, other key cross-functional groups to identify key system performance indicators, assist in product analysis, and report up to the Project Manager Ideal candidates will also possess the following skills/experience:
• Qualifications and Work Experience Required: 5+ years of engineering experience in a manufacturing environment (Medical device preferred). - Quality Background - Validation Engineer - Sustaining Engineer - Mechanical Engineer • Demonstrated fundamental understanding and or strategy of creating equipment validation documentation. - Equipment Qualification - IQ/OQ/PQ • Demonstrated fundamental understanding of manufacturing processes. - Injection molding - Forging - CNC machining - Coating - CMM inspection • Demonstrated experience managing suppliers and resolving supplier issues, particularly for Supplier Innovation role. - Supply Chain Engineer - Sourcing Engineer - Manufacturing Engineer • Demonstrated experience managing small to medium project timelines. - Ability to work independently with low supervision. • Ability to meet project milestones and deadlines on time. - Identify Risk, issues - Resolve using Mitigation tools • Demonstrated familiarity with theory and practical application of ‘Geometric Dimensioning & Tolerancing’ (GD&T) - Must demonstrate basic knowledge • 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.
Global Medical Device Manufacturing Company
Why Work Here?Company is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. Offering a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neuro-technology & spine products to help people lead more active and more satisfying lives
Company offers Meaningful innovation, Growth and Opportunity. It's most Admired Company in Medical Products and Equipment since 2005