Hims & Hers
Sr. Process & Operations Engineer — Menlo Park, CA
$130K–$170K
Menlo Park, California · On-site · Senior · Full-time · Posted Oct 15, 2026
- Experience
- 8+ years of experience in process engineering, operations engineering, or manufacturing engineering within the medical device or diagnostics industry.
- Education
- Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, Manufacturing, or related field).
About the job
Oversee contract manufacturing and process engineering for a Class II FDA-regulated medical device, ensuring compliant, scalable production and continuous improvement.
What you'll do
- Lead CMO operations, monitoring manufacturing performance, quality, timelines, and supplier accountability.
- Develop and improve manufacturing processes; support design transfer, process validation, equipment qualification, and corrective actions.
- Maintain regulatory and quality compliance, support audits and documentation, and coordinate with cross-functional teams on commercialization and production.
What they ask for
- Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, Manufacturing, or related field).
- Experience supporting Class II FDA-regulated medical devices in a GMP manufacturing environment.
- Direct experience managing or working closely with Contract Manufacturing Organizations (CMOs).
- Strong understanding of design controls, process validation (IQ/OQ/PQ), FDA Quality System Regulations (21 CFR Part 820), ISO 13485, CAPA, and change control systems.
Pay
$130K – $170K USD base salary
Tools
FDA Quality System Regulations (21 CFR Part 820), ISO 13485, GMP, IQ/OQ/PQ, CAPA, Lean, Six Sigma
Model-written summary · the original posting is authoritative