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Job

Sr. Mechanical Engineer

  • Job ref:

    8946

  • Location:

    Peterborough, United States

  • Sector:

    Mechanical Engineers

  • Contact:

    Bob Giusti

  • Published:

    6 months ago

Senior Mechanical Engineer

Must have a broad range of engineering skills ranging from R&D concepts thru product development and sustaining engineering with a demonstrated history of developing products with mechanical, electrical and software components. 

Responsibilities

  • Conceptualization: design, prototype, and test concepts for medical devices, components, and other products and technology based on customer needs and user requirements.
  • Development: move a product from concept to a production design.
  • Testing: ensure the design meets functional and safety requirements, is compliant with regulatory standards and meets user needs.
  • Design Transfer: transition designs into volume production, typically with a contract manufacturer.
  • Sustaining: resolve issues for legacy products that are in active production.
  • Design Controls: support the documentation requirements of the medical quality system process, including requirements, design descriptions, drawings, testing, design review, risk management and ECO.
  • Intellectual Property Generation: contribute to and review patents related to current and new products.
  • Communication: provide timeline, budget inputs and status to engineering and project management.

Competencies

  • Analytical and Product Skills: Good analytical and problem-solving skills, with a drive toward innovation. Working knowledge of tooling and manufacturing processes, with the ability to work in a fast-paced, multidisciplinary environment. Demonstrates familiarity with rapid prototyping processes and quick product iteration. Takes a hands-on, sleeves-up approach to engineering.
  • Quality Systems: Understanding of the design control deliverables required of 21CFR Part 820 FDA Quality Systems Regulations and ISO 13485

Experience and Qualifications

  • Minimum of a Bachelors degree in Engineering
  • Minimum of 7 years direct product development experience
  • Experience with device development from concept to commercialization
  • Mechanical engineering background with experience in cross-disciplinary work with electronics and software.
  • Consumer and medical product experience preferred
  • Minimum of 2 years of experience with SolidWorks. Complex surface modeling is a plus.
  • First-hand experience with machining and part fabrication preferred
  • Strong computer skills
  • Strong engineering, design, and analysis skills