Engineering Director, MedTech Ops & Scale-Up

Inspire Medical Systems; Minneapolis (MN); On-site; USD 170,000 - 240,000; Full time

Benefits offered by this job

Health insurance

401k with employer match

Tuition reimbursement

Employee Stock Purchase Program

Job summary

Inspire Medical Systems in Minneapolis, MN is seeking an experienced Engineering Director to shape our Manufacturing Operations and scale the organization for next growth.

You will lead product development, sustaining engineering, and manufacturing readiness, partnering closely with R&D to bring next‑generation devices to market while ensuring FDA/ISO compliance and high product quality.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Biomedical Engineering or related field; Master’s preferred.
• 10+ years of engineering experience in the medical device industry.
• 5+ years in technical leadership roles, managing cross‑functional engineering 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, risk management (ISO 14971), and V&V methodologies.

Responsibilities

• Develop and execute the engineering strategy in alignment with the company’s business goals and long‑term manufacturing roadmap.
• Lead, mentor, and grow a high‑performing team across product development, sustaining engineering, test engineering, and technical operations.
• Build scalable engineering systems, processes, documentation, and organizational structure suitable for a future manufacturing footprint.
• Serve as the key technical voice on the leadership team, contributing to long‑range planning, risk assessment, and organizational readiness for operational scale‑up.

Skills

Leadership

Cross-functional collaboration

Regulatory knowledge

Design transfer

V&V methodologies

Program management

Education

Bachelor’s degree in Mechanical, Electrical, Biomedical Engineering or related field

Master’s degree preferred

Job description

Inspire Medical Systems in Minneapolis, MN is seeking an experienced Engineering Director to shape our Manufacturing Operations and scale the organization for next growth.

You will lead product development, sustaining engineering, and manufacturing readiness, partnering closely with R&D to bring next‑generation devices to market while ensuring FDA/ISO compliance and high product quality.