NPI and Sustaining Systems Engineer, Senior
About The Position
The Senior New Product Introduction and Sustaining Systems Engineer serves as a technical leader within the R&D organization, driving innovation and lifecycle support for multiple new product introduction and commercial medical device products. This position applies Forj Medical Standard Operating Procedures and cross-functional knowledge of electronics, software, and mechanical technologies to support integration and continued manufacturing of embedded medical devices. This role combines deep systems engineering expertise with strategic leadership to ensure product reliability, compliance, and performance throughout the product lifecycle. Assignments may be broad in nature and require creativity and ingenuity.
Requirements
- Bachelor’s or Master’s degree in Systems, Software, Electrical, Mechanical, or Biomedical Engineering or similar
- 4-6 years of experience in medical device development or sustaining engineering
- Experience with Class II and/or Class III products
- Demonstrated understanding and wide application of technical principles, theories, and concepts in the field of medical devices, general knowledge of other engineering disciplines
- Proficient at quickly solving medium-complexity system-level problems
- In depth knowledge of FDA QSR’s, ISO 13485, and IEC 60601 for medical devices
- Experience in interpreting and applying technical regulatory requirements to medical devices
- Excellent interpersonal skills with multiple disciplines & clients
- Ability to work independently and self-driven
- Must be authorized to work in the United States.
Nice To Haves
- Experience in Contract Development & Manufacturing preferred
Responsibilities
- Define, understand and maintain system-level architecture for transfer and commercial products
- Frequent customer interaction
- Lead analysis and trade-off decisions across multiple engineering disciplines
- Scope and drive implementation of design change activities
- Support customer needs for ongoing production of complex electromechanical equipment
- Provide task estimates (scope/schedule/budget) in support of projects, including participation with formal statements of work
- Assess customer design files and related documentation for manufacturing readiness and technical risk
- Lead manufacturing transfer activities, including planning, coordination, and production handoff
- Support pilot builds and early production
- Lead the development of missing documentation as needed
- Drive commercial engineering projects focused on product enhancements, cost optimization, and obsolescence
- Serve as the primary R&D technical authority for manufacturing
- Identify, document, and address concerns related to proposed design changes to established product lines (e.g. flag changes that may impact product safety compliance).
- Ensure adherence to FDA QSR, ISO 13485, IEC 60601 standards and Forj Medical SOPs
- Lead and support process improvement initiatives
- Represent the organization in providing solutions to technical challenges with specific projects
- Provide mentorship of junior engineers
Benefits
- health, dental, vision, 401K plans, and time off programs
- annual bonus program
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What This Job Offers
Job Type
Full-time
Career Level
Senior
