- 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.
- 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.
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Systems Engineering Manager - Marlborough, United States - BioTalent
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:
Responsibilities:
