Engineering Director - Manufacturing & NPD (Medtech)

Inspire Medical Systems, Inc.; Minneapolis, Northern (MN, KY); Hybrid; USD 170,000 - 240,000; Full time

Benefits offered by this job

Health insurance

401k matching

ESPP

Flexible time off

Tuition reimbursement

Job summary

Inspire Medical Systems, Inc. is seeking an Engineering Director to shape the future of Manufacturing Operations.

Reporting to the Vice President of Operations & Supply Chain, this leader will guide engineering functions, scale the organization, and implement scalable processes for product quality and innovation. The role partners with R&D to bring next-generation devices to market, drives continuous improvement, and ensures compliance with FDA/ISO design controls.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Biomedical Engineering or related field.
• 10+ years of engineering experience in the medical device industry.
• 5+ years in technical leadership roles managing cross-functional teams.
• Proven success leading Sustaining Engineering and/or NPD programs under regulated design controls.
• Experience working with contract manufacturers and leading design transfer activities.
• Strong understanding of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and V&V methodologies.

Responsibilities

• Develop and execute the engineering strategy in alignment with the company’s goals and manufacturing roadmap.
• Lead, mentor, and grow a high-performing cross-functional engineering team.
• Build scalable engineering systems, processes, and documentation for a future manufacturing footprint.
• Serve as the technical voice on the leadership team for risk assessment and scale‑up readiness.
• Oversee engineering activities across the product lifecycle, including design controls and post‑market support.
• Lead NPD programs from concept to commercialization under regulatory requirements (FDA/ISO).
• Manage sustaining engineering, enhancements, and cost reductions.
• Collaborate with Quality, Regulatory, Program Management, and Clinical teams to ensure safety and compliance.

Skills

Technical leadership

Sustaining engineering

New Product Development

Regulatory knowledge

Cross-functional collaboration

Risk management

Root cause analysis

Systems engineering

Education

Bachelor's degree in engineering

Master's degree preferred

Job description

Inspire Medical Systems, Inc. is seeking an Engineering Director to shape the future of Manufacturing Operations.

Reporting to the Vice President of Operations & Supply Chain, this leader will guide engineering functions, scale the organization, and implement scalable processes for product quality and innovation. The role partners with R&D to bring next-generation devices to market, drives continuous improvement, and ensures compliance with FDA/ISO design controls.