Systems Engineering Manager

Company: BioTalent
Location: Marlborough
Posted on: April 26, 2024

Job Description:

The role:Our client, a medical device company developing laser-based products, is looking to add a manager of systems engineering to their growing team in Marlborough, MA. Must have Requirements:

• 10+ years' experience in research and development a focused on opto-mechanical or laser-based devices.
• 10+ years' experience in in engineering management in ISO 13485 and FDA regulated environments.
• Background in lab experiments involving optical, electrical, mechanical, and electronic components.
• Experience integrating laser, opto-mechanical, electrical, and industrial design elements, as well as embedded and application software, in the development of laser medical products.
• Experience in rapidly prototyping solutions for pre-clinical and clinical studies.
• Experience with Design Controls and Risk Management practices, regulations, and standards, including FDA QSRs, ISO 13485, EU MDR, ISO 14971, IEC 60601, 60825, and 62366.Responsibilities:
  • Lead product development from design through to verification and validation.
  • Collaborate with marketing, customers, and internal stakeholders on specifications.
  • Coordinate the technical aspects of product transfer to customers or distributors.
  • Implement cost reduction programs for medical products.
  • Develop documentation, including the design history file, to support product regulatory approval and manufacturing processes.
  • Manage cross-functional projects involving external resources and contracted companies, formulating and obtaining approval for project plans in consultation with senior management and stakeholders.
  • Manage program budgets, generate forecasts, and track actuals against forecasts.

Keywords: BioTalent, Lynn , Systems Engineering Manager, Executive , Marlborough, Massachusetts