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The Restorative Therapies Group (RTG) is looking for a Senior Manufacturing Engineer to join the Contract Manufacturing (CM) Operations engineering team. The contract manufacturing engineering organization is responsible to source finished medical products from over 200 Contract Manufacturing and OEM manufacturing partners throughout the world. This position will be located at the Medtronic Littleton MA office and provide engineering support for O-arm X Ray imaging equipment. The Principal Manufacturing Engineer will be responsible to support Contract Manufacturing (CM) operations by leading manufacturing product improvements including cost, manufacturability, quality, and reliability goals. Responsible for planning, designing, developing, and maintaining assembly and test procedures, tools, programs, and training. Provide direction and support for existing products including product and/or feature enhancements as well as resolve issues with electro/mechanical assemblies that may arise on the manufacturing floor throughout the lifecycle of product.
Day in the life:
• Develops, maintains and improves procedures, documentation, tools, fixtures, and programs on existing printed circuit boards, electro-mechanical assemblies, and final products.
• Identify the root cause of manufacturing process and product nonconformities. Identify and implement the necessary actions to correct and prevent recurrence though the corrective and preventative action process.
• Collaborate with supplier(s) to design, characterize and qualify high capability processes producing consistent finished device medical products. This may include supporting process risk assessments (pFMEA), establishing process flows, developing control plans, conducting process validations (IQ, OQ, PQ), and setting product acceptance criteria.
• Strong understanding of Master Validation, including Validation Master Planning, Installation Qualification, Operational Qualification, and Performance Qualification.
• Provide technical oversight for manufacturing production performance, including product yield and cycle time management, and driving continuous improvements. Promote working in a data-driven environment. Provide focus and clarity for continuous improvements using Key Performance Indicator (KPI) metrics. Participate in supplier Monthly Operations Reviews (MOR) as-required.
• Lead and implement data-driven quality and manufacturing improvement for product design, assembly process, and supply chain management.
• Works in conjunction with Product Development engineering in the creation of processes and procedures, including test programs to verify the performance to specification of new assemblies, peripherals, and products.
• Responsible for the maintenance of production test programs upon release to production. Investigates and introduces new technologies into production (i.e TQM, Automated Test).
• Initiates and/or approves all necessary changes in design, drafting, tooling, methods, processes and any documentation that affects the manufacturability of an item or process including Process Validation protocols and continuously improves manufacturing practices.
• Understand Work Flow Maturity and promote an expectation that our supply partners are driving toward maturity, with a continuous improvement mind set, to provide predictable supply that meets quality and cost targets.
• Reviews supplier change notices and leads cross-functional team to determine proper part and assembly procurement actions and executes ECO’s to process changes and phase into production.
• Trains technicians on production methods, equipment, and procedures for new and existing assemblies and products.
• Ensures all engineering activity is in full compliance with applicable Medtronic quality system requirements, regulatory approvals, and other agency requirements as-identified.
• Develop and Improve Operations Quality System Processes to meet local and Corporate Quality initiative goals.
• Implements and maintains safe operating procedures, tools and equipment which comply with safety standards.
• Support for cost reduction activities, including outsourcing for cost savings.
• Local and International travel is required. Ability to travel up to 25% of the time.
• All activities must be performed in compliance with the Quality System
• Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations
• Maintain a standard for technical rigor in engineering consistent with Medtronic performance expectations, including but not limited to advanced statistics, design of experiments, hypothesis testing, variables-data distribution analysis, attribute-data success testing, sample size calculation, process capability analysis, statistical process control.
• Promote Value Analysis/Value Engineering as a systematic process to creatively assess and generate alternatives to identify essential functions at the greatest value. Value engineering through the systematic method to improve output by using rigorous examination of function.
• Support the strategic operations cost reduction initiative to deliver a minimum of 6% cost savings across a portfolio of finished product, components, and materials.
• All other duties as assigned.
Must Have: Minimum Qualifications
- Bachelor's Degree in Electrical Engineering, Mechanical Engineering or similar engineering discipline or related technical field
- 4+ years of relevant experience with Bachelors Degree OR 2+ years of relevant experience with Masters Degree
Nice to Have
• Advanced Degree - M.S. or Ph.D. in Engineering, or similar relevant discipline.
• Understanding of Lean Manufacturing, and Six Sigma, certification preferred (Green Belt, Black Belt)
• Experience in medical device manufacturing or technology preferred.
• Project Management Certification (PMP) or at least working knowledge of project management techniques.
• Knowledge of x-ray equipment and/or other capital equipment.
• Previous work experience within Advanced Robotics, Imaging Equipment, X-Ray equipment, medical device manufacturing, contract manufacturing, manufacturing of electronic products.
• Demonstrated working knowledge of ISO 9001.
• Experience in FDA 21 CFR Part 820 Medical Device Manufacturing, or ISO 13485.
• Experience in Statistical methodologies; DOE, SPC, etc.
• Experience with CAD systems: SolidWorks (or equivalent), Electrical Simulation Tools.
• Demonstrated experience leading projects in engineering or program management environment.
• Experience with process development, process characterization, process verification and validation, or component / material qualification, and acceptance testing.
• Experience with risk management, including but not limited to Process Failure Mode Effects Analysis (pFMEA), Design Failure Mode Effects Analysis (dFMEA), fault tree analysis, or other risk management tools.
• Understanding of advanced structured problem-solving methodology such as Kepner-Tregoe, Kaizen, Lean Six Sigma, or other methods.
• A self-motivated team player with excellent verbal and written communications skills. Must be able to convey business and technical concepts to diverse stake-holders and technical teams in a clear and concise manner.
• Ability to set work direction, work independently, and communicate with a vast network of global stakeholders.
• Experience in Windows applications including Microsoft Office.