Senior Process & Operations Engineer - Regulated Devices (Remote)

Hims; Minnetonka (MN); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Competitive salary

Equity compensation

Unlimited PTO

Health benefits

ESPP

401k with match

Offsite retreats

Job summary

Hims is seeking a Senior Process / Operations Engineer – Regulated Devices to oversee contract manufacturing for a Class II FDA-regulated medical device. You will act as the primary operations liaison with CMOs, ensuring processes, quality, and performance meet regulatory and business requirements.

Cross-functional collaboration with R&D, Quality, Regulatory Affairs, and Supply Chain is essential. The ideal candidate brings extensive experience in medical device process engineering, supplier/CMO

Qualifications

• Bachelor’s degree in Engineering or related field required.
• 8+ years in process/operations/manufacturing engineering in medical device or diagnostics.
• Experience with Class II FDA-regulated devices in GMP environment.

Responsibilities

• Oversee external CMOs, ensure manufacturing performance and quality metrics.
• Coordinate with R&D for manufacturability and scale-up.
• Lead CAPAs and root-cause investigations in production.
• Ensure documentation, DHRs, and validation records meet regulatory standards.
• Collaborate with Quality, Regulatory, and Supply Chain for audits and continuous improvement.

Skills

Regulatory compliance

CMO management

Process engineering

GMP experience

Cross-functional collaboration

Education

Bachelor’s degree in Engineering

Tools

IQ/OQ/PQ validation

CAPA systems

Design controls

Job description

Hims is seeking a Senior Process / Operations Engineer – Regulated Devices to oversee contract manufacturing for a Class II FDA-regulated medical device. You will act as the primary operations liaison with CMOs, ensuring processes, quality, and performance meet regulatory and business requirements.

Cross-functional collaboration with R&D, Quality, Regulatory Affairs, and Supply Chain is essential. The ideal candidate brings extensive experience in medical device process engineering, supplier/CMO