Sr Operations Engineering

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Sr Operations Engineering

  • Specialty:

  • Title:

    Sr Operations Engineering
    • City:

      Eden Prairie
    • State:

    • Zip Code:

  • Start date:

  • Status:

  • Assignment Type:

    Direct Hire
  • Job Id:



Position Summary:

This is a technical, hands-on engineering position that works as an integral member of product development teams (sustaining and NPD), utilizes data to identify opportunities, leads projects and implements changes focused on improving product performance and reliability, product enhancements, component obsolescence, increasing capacity, process capability and meeting our commitments.

Primary Duties and Responsibilities:

80% Product Development & Operations Support

  • Performs work in accordance with Regulatory Requirements (i.e. FDA, MDR, UL, CE and other governing bodies) and Quality Management System (QMS), including development and maintenance of documentation
  • Supports compliance to Regulatory Requirements
  • Enhances and utilizes metrics to identify opportunities, prioritize, lead projects and implement necessary changes focused on; supporting daily production; improving product performance and reliability; product enhancements; component obsolescence, increasing capacity and process capability; reducing lead-times, scrap, rework and operating costs; enhancing customer experiences; and meeting our commitments
  • Uses data, product application (use-cases), internal and external information, knowledge of healthcare and sound engineering judgment to make decisions
  • Develops, maintains & communicates project plans, coordinates project activities, sets / adheres to milestones and action list
  • Partners with cross-functional team to actively manage contract manufacturers and suppliers in support of business strategiesWorks as an integral member of new product development teams, helps to define requirements, creates processes and test systems, identifies suppliers and ensures products meet customer and market expectations

People Leadership

  • Works collaboratively with other departments (product development, supply chain, manufacturing, quality, customer support, field services, finance, sales and marketing)
  • Provides transparent communications and encourages active exchange of ideas and information
  • Provides work direction to less-senior operations engineers and technicians
  • Collaborates with others who have supplemental knowledge and skills required to complete projects
  • May perform some personnel functions, including identifying resource needs, hiring, on-boarding, performance evaluations, terminations, promotions and salary decisions
  • Utilizes motivational techniques / tools to drive high levels of employee engagement and performance

Qualifications: Min:

  • B.S in Engineering or equivalent degree (i.e. Physics)
  • 4 – 7 years relevant experience
  • 2+ years medical device experience
  • Demonstrated continuous improvement experience
  • Understand system requirements (i.e. GMP, QSR, GLP, CE, CSA, ISO, etc.)
  • Passion and commitment to learn and improve to achieve personal and company goals
  • Experience in project leadership (including writing and executing project plans) with flexible approach and ability to influence others
  • Assertive self-starter with excellent organizational, interpersonal, critical thinking, verbal and written communication skills
  • Ability to identify required data, collect, consolidate and analyze for assessment, decision making and reporting utilizing problem solving and continuous improvement methodologies (i.e. PDCA, DMAIC, A3, 8D)
  • Knowledge of how to properly analyze data sets using statistical software (i.e. Minitab, JMP, LabVIEW, etc.)
  • Understand some statistical methods, problem solving and continuous improvement tools (i.e. regression analysis, ANOVA, reliability, equivalence tests, histograms, pareto charts, trend charts, control charts, process capability, Process Flow Diagrams, Process Maps, Value Stream Maps, RCA {5-why, fish bone diagram, cause mapping}, fault tree analysis, cause and effect matrix, prioritization matrix, FMEA, DOE, MSA, MTTR / MTBF, Poka-Yoke, control plans)


  • Proven ability to mentor and develop technical team
  • Agile / SAP (or similar documentation control / MRP systems)
  • Experience supporting capital and / or consumable medical device products
  • Experience working with medical device contract manufacturers
  • Experience working with different global cultures
  • Technical project management skills / Project Management Professional (PMP)
  • Knowledge of how to use test instruments (i.e. multi-meter, oscilloscope, spectrum analyzer, logic analyzer, etc.)
  • Ability to model in SolidWorks or Altium (or similar)


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