The Lead system engineer is responsible for leading the design and development activities of multidisciplinary complex medical In Vitro Diagnostic products (inclusive of software) from concept proofing until the implementation process. The individual will collaborate, perform and serve as a professional authority and a key interface to diverse team of engineers, project teams, vendors, compliance agencies and regulatory bodies. This is a senior leadership role which requires an in depth understanding of the influences on medical device development from sources such as regulatory, compliance and ISO 13485 registered quality systems.

Detailed Job Expectations

  • Develop detailed specifications, construction of prototypes for current and new products.
  • Manage requirements, interface specifications, systems models and tests relative to development milestones and help define and refine Systems Engineering & Design Control processes and practices
  • Work closely with engineering teams to plan / de-risk remaining development work, taking into account key interactions and interfaces
  • Serve as key interface point with external development partners
  • Contribute to design and define product testing plans and protocols. Perform testing, analyze results, suggest recommendations and/or conclusions and document clearly and completely in technical reports.
  • Ensure that product documentation is in accordance with Quality System requirements design control, quality, and company regulations and national and international regulatory body requirements.
  • Maintain and manage activities towards the overall project schedule, and ensure that critical timelines are established and met.
  • Ensure that new products are designed to facilitate manufacturability.

Requirements

  • BS/MS in Biomedical, Electrical, Mechanical Engineering, physics or Systems Engineering
  • Minimum 10 years overall engineering experience in an interdisciplinary product development environment
  • 5 years of this experience in a SE role while operating under a registered QS and the FDA QSR
  • Demonstrated competency in program planning, e.g. developing work breakdown structures, resource planning, program risk management
  • Thorough understanding of and leading requirements management; from development through verification and validation; experience with requirements management tools
  • Thorough understanding and working knowledge of ISO 14971:2007; experience in leading safety risk management activities, e.g. Hazard Analyses, FTA, and FMEA
  • Experience in leading the development of product/system architectures
  • Thorough understanding of safety compliance process (product safety marks)
  • Thorough understanding of and leading Design Verification activities
  • Experience in conduct and support of Design Validation activities
  • Experience in conduct and support of device clinical trials
  • Experience in supporting marketed products
  • Familiarity of applicable EU New Approach Directives, e.g. MDD, IVDD
  • Familiarity of regulatory submissions, e.g. FDA 510(k), CE Marking
  • Working knowledge of available industry reference resources, e.g. AAMI, RAPS, INCOSE

Desired Qualifications

  • Experience in obtaining a device safety mark (e.g. CSA, UL)
  • Experience in conduct and support of pre-clinical studies
  • Membership in professional organizations, e.g. AAMI, RAPS, IEEE, INCOSE
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