Job Summary:
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.
Essential Duties and Responsibilities:
Technical Leadership & Architecture
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
NPI Support
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
Lifecycle Management & Commercial Product Engineering
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).
Compliance & Quality
Ensure adherence to FDA QSR, ISO 13485, IEC 60601 standards and Forj Medical SOPs
Lead and support process improvement initiatives
Cross-Functional Collaboration & Mentorship
Represent the organization in providing solutions to technical challenges with specific projects
Provide mentorship of junior engineers
Qualifications:
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
Experience in Contract Development & Manufacturing preferred
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
