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Product Development Engineer

Job description

Our Client is seeking a Product Development Engineer to join their dynamic team. The Product Development Engineer will be responsible for supporting both new and sustaining R&D product development activities. This role includes providing project management and design control support for new product development projects, as well as all sustaining engineering activities. The ideal candidate will have experience in medical device component and material processing, design, and manufacturing. Successful candidates will be reliable, collaborative team players with excellent multitasking, communication, and time management skills.
Duties and Responsibilities:
  • Collaborate with marketing to translate customer requirements into actionable specifications.
  • Assist with the design of novel product concepts based on customer needs.
  • Support the design and development of new and existing products and associated assembly and manufacturing processes.
  • Work directly with Regulatory and Quality consultants to complete/satisfy all design control deliverables required for the communicated regulatory strategy and submissions.
  • Work directly with manufacturing to complete/satisfy all manufacturing deliverables for each new and sustaining engineering objective.
  • Manage Design FMEA(s) and drive cross-functional participation for these documents.
  • Coordinate/write protocols as required to develop/document all testing protocols for V&V and customer input.
  • Coordinate and complete the following as needed for all new development and sustaining engineering objectives:
    • Project Schedule
    • Quality and Regulatory documents
    • Labeling and IFU changes
    • Design Requirements - Trace Matrix
    • Design Specifications - Trace Matrix
    • Real Time Aging retention, testing
    • V&V testing, documentation
    • Testing protocols and reports
  • Support Engineering Evaluation of returned product when needed.
  • Competitive product evaluation including standard testing.
  • Support change Orders, technical review, implementation when needed.
  • Remain current with all internal and appropriate external developments and policies in related areas of activity.
  • Provide other department support as requested by immediate supervisor or senior management.
  • Interface with vendors and manufacturing as required when implementing new designs and/or completing sustaining engineering changes.
  • Provide input as required related to the intellectual property strategy for new and existing designs.
Desired Knowledge, Skills and Abilities:
  • Bachelor's level degree in Engineering / Technology preferred.
  • At least 2-3 years of design control and/or quality system experience in a regulated industry, preferably medical devices.
  • Experience in medical device component and material processing, design, and manufacturing.
  • A comprehensive understanding of ISO, GMP and FDA regulations for development.
  • Experience in the commercialization of medical devices in the U.S. and globally is preferred.
  • Strong analytical and problem-solving skills and comprehensive understanding of design control processes and validation of processes and designs.
  • Proven project management skills.
  • Effective verbal, presentation and written communication skills.
  • Proficient in Microsoft Office, and MS project.
  • Working experience in Solidworks.
  • Working knowledge of medical device development, sterilization requirements and techniques, and medical device regulations.
  • Ability to travel up to 10-20%.