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Manager, Sustaining Engineering

Job Summary:

The Sustaining Engineering Manager is responsible for leading the Instrument and Cartridge Sustaining engineering function within the Operations Organization. The Sustaining Engineering Manager is responsible for providing the engineering leadership for the Operations organization and management of the Sustaining Engineering team.  Primary support includes ongoing improvements to cost, quality, and Manufacturing efficiency through new and existing OEM partnerships for our Instrument and Cartridge product lines.

Essential Functions:

  • Manages the Sustaining Engineering staff in the support of programs to assure that existing and new Instrument and Cartridge designs can be manufactured cost effectively.
  • Reviews new Instrument and Cartridge product designs for manufacturability, provides oversight of pilot production for new products and assists with the development of manufacturing-related inputs to new product teams.
  • Leads Sustaining Engineering staff in the preparation and maintenance of procedures and instructions in an ISO-13485/GMP environment;
  • Responsible for research, development, and documentation of practices, processes, manufacturing flow, facilities and tooling development necessary to support the manufacture of Instrument and Cartridge products in an efficient and cost effective manner.
  • Leads the development of manufacturing test systems for both hardware and software.
  • In partnership with the Quality Organization, provide technical solutions for Manufacturing or customer issues.
  • Develops schedules and ensures milestones are met, work is prioritized and that adequate resources are made available to support such schedules.
  • Provides technical assistance and training to production work teams.
  • Leads overall technical strategy with assistance of the Operations leadership team with the development of department direction and plans to carry out overall operations plans and functions. Actively participates in strategic and tactical planning.
  • Establishes annual "smart" goals for personnel in support of growth and meeting departmental objectives.
  • Coaches and mentors staff towards overall development and growth
  • Assures that departmental training tools are in place and that periodic training is scheduled and held as appropriate.

Requirements:

  • Bachelor's degree (B.S.) in Industrial, Manufacturing or Mechanical Engineering required.
  • Minimum of 5 years related experience in an operational environment in Manufacturing Engineering, Industrial Engineering, Mechanical Engineering. Prior design, molding, or automation experience a plus. Experience in high volume manufacturing as well as manual assembly operations.
  • Manufacturing experience in an ISO=13485 (Medical Device)/GMP environment
  • Minimum 3 years engineering management experience
  • Specific Skills
  • Ability to coordinate and facilitate discussions between Operations, Quality, R&D, Service and/or Customers regarding the design and manufacture of Instrument and Cartridge products
  • Ability to understand and apply Risk Analysis and FMEA concepts.
  • Have a proven track record working with SolidWorks CAD software and Enterprise Product Data Management (EPDM)
  • Knowledge of microfluidics systems and micro fabrication techniques.
  • Understanding of metal stamping, progressive dies, injection molding, and high cavitation tooling preferred
  • Ability to utilize Microsoft Office Suite
  • Outstanding verbal and written communication skills
  • Process-oriented mentality
  • Strong problem solving capabilities
  • Strong project management skills

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