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, Chelsea , Systems Engineering Manager, Executive , Marlborough, Massachusetts
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