Staff Engineer, Advanced Operations in Carrigtohill at Stryker Corporation

发布日期: 9/23/2019

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职位描述

Position Summary

This role requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 4 or more years experience.

Designs, validates and brings new products to market. Specifies precise new product functional requirements; designs, tests and integrates components to produce final designs; and evaluates the design's overall effectiveness, cost, reliability and safety. Designs, develops, executes and evaluates fitness-for-use testing, product specifications and process validation plans; creates and reviews material part specifications and bills of materials. Collaborates with internal manufacturing partners, contract manufacturers, designers and product specialists to optimize designs for manufacturability. Utilizes CAD (Computer Aided Design) or CAE (Computer Aided Engineering) systems to model new designs and produce detailed engineering drawings.

Main Duties & Responsibilities:

  • Independently determines and develops approaches to a variety of technical problems of moderate scope and complexity.
  • Uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs.
  • Builds productive internal and external working relationships and may periodically provide guidance and train other team members.
  • 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.
  • May lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
  • Will analyse equipment to establish operating data, conduct experimental test and result analysis.
  • Lead and/or participate in process review meetings. •
  • Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.
  • Complete capability studies for in process inspection and generate subsequent Inspection documentation.
  • Conduct MSA studies for new products and new processes.
  • Provide training for manufacturing team members.
  • Ensure adherence to GMP and safety procedures.
  • Review and approval of validation documentation.
  • All other duties as assigned.

Qualifications

  • B.S in Mechanical Engineering or related engineering discipline with 4 or more years’ experience or a related masters degree. •

Experience Required

  • 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 recognise 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, organise 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 dimensioning and tolerancing.
  • 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: No

Travel Percentage: Up to 25%

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