# Sr. Process & Operations Engineer — Menlo Park, CA

**Company**: Hims & Hers
**Location**: Menlo Park, California
**Work arrangement**: onsite
**Experience**: senior
**Job type**: Full time
**Salary**: $130K - $170K
**Category**: Engineering
**Industry**: Healthcare

**Apply**: https://jobs.ashbyhq.com/hims-and-hers/bf0f2e0d-2139-406c-87e2-ee595bb233dd?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_3a80a8f1-a5c

## Description

## Compensation

The salary range for this role is $130K – $170K for Zone A (California) and $130K – $150K for Zone B (Minnesota & Massachusetts).

## About the Role:

The Senior Process / Operations Engineer – Regulated Devices oversees contract manufacturing operations for a Class II FDA-regulated medical device.

## Responsibilities:

### Contract Manufacturing Oversight

- Serve as primary technical operations lead for external contract manufacturers and critical suppliers.

- Oversee day-to-day manufacturing performance, quality metrics, and operational execution at CMOs.

- Ensure manufacturing processes consistently meet product specifications, quality standards, and production targets.

- Drive accountability with manufacturing partners regarding timelines, deviations, CAPAs, and continuous improvement initiatives.

### Process Engineering & Manufacturing Support

- Develop, optimize, and sustain manufacturing processes for Class II medical devices and consumables.

- Partner with R&D during product development and design transfer activities to ensure manufacturability and scalability.

- Support process characterization, validation, and verification activities, including IQ/OQ/PQ validation, process capability studies, equipment qualification, and manufacturing line readiness.

- Lead root cause investigations and implementation of corrective and preventive actions (CAPAs) related to manufacturing or process issues.

- Monitor process performance and identify opportunities for yield improvement, cost reduction, and operational efficiency.

### Quality & Regulatory Compliance

- Ensure all manufacturing activities comply with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, GMP requirements, and internal quality system procedures.

- Collaborate closely with Quality Assurance to address nonconformances, deviations, change controls, and audit findings.

- Support supplier qualification, supplier audits, and ongoing supplier quality management activities.

- Ensure manufacturing documentation, Device History Records (DHRs), and validation records are complete and compliant.

### Cross-Functional Collaboration

- Work closely with R&D teams to transition new products from development into commercial manufacturing.

- Partner with Supply Chain and Planning teams to support production schedules, inventory management, and demand planning.

- Support Regulatory Affairs with manufacturing-related documentation for regulatory submissions and inspections.

- Coordinate with Packaging, Sterilization, and Logistics teams to ensure seamless product release and shipment readiness.

### Operational Excellence

- Establish and monitor KPIs related to manufacturing quality, throughput, scrap, and supplier performance.

- Drive continuous improvement initiatives using Lean, Six Sigma, or similar methodologies.

- Support implementation of scalable operational processes as the company grows.

- Assist in risk assessments and mitigation activities related to manufacturing and supply continuity.

## Requirements:

- Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, Manufacturing, or related field).

- 8+ years of experience in process engineering, operations engineering, or manufacturing engineering within the medical device or diagnostics industry.

- Experience supporting Class II FDA-regulated medical devices in a GMP manufacturing environment.

- Direct experience managing or working closely with Contract Manufacturing Organizations (CMOs).

## Nice to Have:

- 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.

- Experience collaborating with Quality, Regulatory, and R&D teams in a regulated environment.

## Benefits:

- Competitive salary & equity compensation for full-time roles.

- Unlimited PTO, company holidays, and quarterly mental health days.

- Comprehensive health benefits including medical, dental & vision, and parental leave.

- Employee Stock Purchase Program (ESPP).

- Employee discounts on hims & hers & Apostrophe online products.

- 401k benefits with employer matching contribution.

- Offsite team retreats.

## Skills

### Required
- Process Engineering
- Operations Engineering
- Medical Device Manufacturing
- FDA Quality System Regulations
- ISO 13485
- CAPA and Change Control Systems

### Nice to have
- Lean
- Six Sigma
- Design Controls
- Process Validation

---

Source: [Apply at jobs.ashbyhq.com](https://jobs.ashbyhq.com/hims-and-hers/bf0f2e0d-2139-406c-87e2-ee595bb233dd?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)