Senior Manufacturing Process Engineer

Position Summary:

This position requires a dynamic, energetic, self driven, engineer with a broad technical background.  The Senior Manufacturing Process Engineer will support manufacturing operations for the production of complex electro-mechanical handheld instruments through the New Product Introduction process. This individual will be responsible for management of the contract manufacturer as well as the implementation and validation of manufacturing lines for Intuity products. Work closely with product development engineering, quality, materials planning and sourcing in order to ensure manufacturability, achievement of cost targets, and develop processes for optimum manufacturability.  Develop manufacturing documentation (specification, drawings) to support build and testing, and directly work with manufacturing/Contract manufacturers to build prototypes, pilot, and production instruments as appropriate.  Troubleshoot and implement changes that improve manufacturing quality and product performance via activities such as historical data and failure analysis, test design, documentation, and the implementation/validation of equipment and process changes.

Senior Manufacturing Process Engineer

Position Summary:

This position requires a dynamic, energetic, self driven, engineer with a broad technical background.  The Senior Manufacturing Process Engineer will support manufacturing operations for the production of complex electro-mechanical handheld instruments through the New Product Introduction process. This individual will be responsible for management of the contract manufacturer as well as the implementation and validation of manufacturing lines for Intuity products. Work closely with product development engineering, quality, materials planning and sourcing in order to ensure manufacturability, achievement of cost targets, and develop processes for optimum manufacturability.  Develop manufacturing documentation (specification, drawings) to support build and testing, and directly work with manufacturing/Contract manufacturers to build prototypes, pilot, and production instruments as appropriate.  Troubleshoot and implement changes that improve manufacturing quality and product performance via activities such as historical data and failure analysis, test design, documentation, and the implementation/validation of equipment and process changes.

Position Description and Responsibilities:

  • Act as the primary technical point of contact; work with our Contract Manufacturer to transfer and scale the POGO meter manufacturing process.
  • Responsible for preparation and execution of validation protocols and completion of validation reports.
  • Provide expertise in project planning and timeline development & management and maintain project schedules and timelines
  • Work with local and international suppliers and manufacturing sites to generate capacity/capability models and make vs. buy assessments used as an input to site planning
  • Implement and manage process improvement and cost reduction programs.  Monitor product quality and production rates.  Ensure capacity is appropriate for the manufacturing plan.
  • Effectively utilize lean manufacturing tools for continuously improve the flow of material and information in the factory including factory layouts, visual management, 5S, JIT, Kanban
  • Assist in product failure investigations and design changes required to improve product reliability and performance.
  • As a member of the design team, evaluate and challenge mechanism designs for technical merit, reliability, and manufacturability.
  • Propose, review and approve design changes and change orders form a manufacturing and field perspective
  • Manage development transfer activities between R&D, Product development and operations to contract manufacturers
  • Approve design releases to manufacturing, review engineering documentation, and provide vendor and in-house DFM inputs.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.

Position Qualifications:

  • Experience managing teams and leading large complex cross functional projects involving, electrical, electro-mechanical, optical and software elements.
  • Strong problem solving and analytical skills; experience with use of statistical analysis and design of experiments for product optimization and validation activities
  • Experience with lean manufacturing, design for manufacturing, design for test and test implementation
  • Proficient in 3D mechanical modeling with SolidWorks
  • Excellent organizational, verbal and written communication skills as well as attention to details
  • Ability to coach and develop employees and develop effective cross functional relationships
  • Able to interface with all levels and functions of the organization; requires a cooperative team-balanced perspective for appropriate output and task outcome
  • Experience working in regulated product and manufacturing environments (ISO, FDA, cGMP)

Minimum Education:

  • Minimum of a BS in a related science discipline

Minimum Experience:

  • 6+ years’ experience in all phases of Process/Manufacturing development to launch for high volume commercial or medical devices
  • 3+ years in a senior engineering role either leading a team or acting as the primary technical interface to a CM

Working Conditions:

  • Travel required 20%