Description

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

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

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.

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.

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.

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.

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.

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).

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.

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.

This listing is enriched and indexed by YubHub. To apply, use the employer's original posting: https://jobs.ashbyhq.com/hims-and-hers/bf0f2e0d-2139-406c-87e2-ee595bb233dd