Senior Staff Engineer, Advanced Operations

8 - 10 years experience  •  Pharmaceuticals & Biotech

Salary depends on experience
Posted on 06/28/18
Portage, MI
8 - 10 years experience
Pharmaceuticals & Biotech
Salary depends on experience
Posted on 06/28/18

25542BR

Job Description

"Responsible for creating a work practice and environment that pushes the boundaries of conventional manufacturing & metrology.  Role success will be gauged by this individual’s contribution in coaching the engineering team to effectively meet and/or exceed new product metrics including product cost, process performance and time to market.  

  • Determines the technical objectives of engineering assignments and makes decisions regarding the direction and the results of the assignment.
  • Will monitor and control progress of work ensuring sound application of engineering principles and the appropriate use of policies and procedures.
  • Lead capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
  • Will analyze equipment to establish operating data, conduct experimental test and result analysis. May lead or act as independent reviewer in process review meetings.
  • Will coach and mentor others on functionally related topics.
  • Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures.
  • Ensure quality of process and product as defined in the appropriate operation and material specifications.
  • Will select components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.
  • Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.
  • Ensure adherence to GMP and safety procedures.
  • Review and approval of validation documentation.
  • All other duties as assigned.
  • B.S in Mechanical Engineering or related engineering discipline
  • 7 or more years’ experience; Related mastersdegree with 2 or more years of experience or PhD may be desirable
  • General Knowledge of AGMA gear standards.
  • Proficient in gear design theory (spurs, helicals, spiral bevels)
  • Proficient with Gear processing: Heat treat, shot peening, Hobbing, grinding, shaping, etc.
  • Proven track record of working in a team based environment.
  • Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams. Be open minded with the ability to recognize good ideas.
  • Innovative thinker - should be able to envisage new and better ways of doing things.
  • Experience in executing complex problem solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design.
  • Good understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques.
  • Excellent analytical skills, ability to plan, organize and implement concurrent tasks.
  • Good knowledge of manufacturing processes, materials, product and process design.
  • Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimension and tolerance.
  • Certified in validation activities.
  • Experience in an FDA regulated or regulated industry beneficial.
  • High level of PC Skills required.
  • Excellent attention to detail.

Work From Home: NoTravel Percentage: Up to 25%

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