NPI and Sustaining Systems Engineer, Senior

Forj Medical; Minnesota; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

401K plans

Annual bonus program

Job summary

Forj Medical in St Paul, MN is searching for a Senior NPI and Sustaining Systems Engineer to provide technical leadership in the development of medical devices. This role involves defining system architecture, leading engineering trade-off analysis, and ensuring compliance with regulatory standards.

Ideal candidates will have 4-6 years of experience in medical device development and a strong understanding of FDA regulations. A competitive Total Rewards Package is offered.

Qualifications

• 4-6 years of experience in medical device development or sustaining engineering.
• Experience with Class II and/or Class III products.
• In-depth knowledge of FDA QSR’s, ISO 13485, and IEC 60601 standards.

Responsibilities

• Define system-level architecture for products.
• Lead analysis and trade-off decisions across engineering disciplines.
• Ensure adherence to regulatory standards for medical devices.

Skills

Interpersonal skills

Problem-solving ability

Systems architecture knowledge

Compliance knowledge

Education

Bachelor’s or Master’s in Engineering

Job description

NPI and Sustaining Systems Engineer, Senior

1635 Energy Park Dr, St Paul, MN 55108, USA

Job Description

Posted Saturday, June 27, 2026 at 6:00 AM

Exceptional People. Hard Problems. Meaningful Careers. Big Impact.

Nowhere else can you touch as many life-changing medical technologies. At Forj Medical, we work side by side with more than 100 medical device companies from startups to global giants to bring life-enhancing technologies to market. Working with us means solving hard problems with extraordinary people in a collaborative work environment. Join us.

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
• 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
• 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

EEO Statement

Forj Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Employment Requirement

Must be authorized to work in the United States.

Compensation and Total Rewards Package

The salary range for this position is outlined below under “Job Details” and is dependent upon the individual's skills, experience, qualifications, and applicable employment laws. Beyond base salary, Forj offers a competitive Total Rewards Package. We offer health, dental, vision, 401K plans, and time off programs. You may also be eligible to participate in an annual bonus program which depends on various factors, including, individual and organizational performance.

1635 Energy Park Dr, St Paul, MN 55108, USA