Senior Medical Device Process & Ops Engineer

hims & hers; Minnetonka (MN); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Competitive salary & equity

Unlimited PTO, holidays

Comprehensive health benefits

ESPP

Employee discounts on hims & hers

401k with employer matching

Offsite team retreats

Job summary

Hims & Hers, a health and wellness platform, seeks a Senior Process / Operations Engineer – Regulated Devices to oversee contract manufacturing for a Class II medical device. You’ll interface with CMOs, ensure FDA/ISO compliance, and drive process improvements across R&D, QA, and supply chain.

You will manage process validation, CAPAs, and line readiness while partnering with cross-functional teams to scale production and ensure quality from development to commercialization.

Qualifications

• Bachelor’s degree in engineering and 8+ years in medical device manufacturing.
• Experience with Class II FDA-regulated devices in GMP environments.
• Direct experience managing or partnering with CMOs.
• Strong understanding of design controls and IQ/OQ/PQ validation.

Responsibilities

• Serve as the primary technical operations lead for external CMOs and key suppliers.
• Oversee daily manufacturing performance, quality metrics, and execution at CMOs.
• Ensure processes meet specifications, quality standards, and targets.
• Drive accountability with partners on timelines, deviations, CAPAs, and improvements.
• Develop, optimize, sustain manufacturing processes for Class II devices.
• Collaborate with R&D during product development and design transfer.
• Support validation activities, process characterization, equipment qualification.
• Establish KPIs for quality, throughput, scrap, and supplier performance.

Skills

Process engineering

Regulated manufacturing

CMO management

Cross-functional collab

Education

Bachelor's degree in Engineering

Job description

Hims & Hers, a health and wellness platform, seeks a Senior Process / Operations Engineer – Regulated Devices to oversee contract manufacturing for a Class II medical device. You’ll interface with CMOs, ensure FDA/ISO compliance, and drive process improvements across R&D, QA, and supply chain.

You will manage process validation, CAPAs, and line readiness while partnering with cross-functional teams to scale production and ensure quality from development to commercialization.