Systems Engineering Manager
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.
Recommended Skills Clinical Works Consulting Electronics Manufacturing Experimentation Financial Management Forecasting Apply to this job.
Think you're the perfect candidate? Apply on company site Estimated Salary: $20 to $28 per hour based on qualifications.
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.
Recommended Skills Clinical Works Consulting Electronics Manufacturing Experimentation Financial Management Forecasting Apply to this job.
Think you're the perfect candidate? Apply on company site Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
