Senior Medical Device NPI & Sustaining Systems Engineer

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

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.