Sr. Process & Operations Engineer

Hims & Hers•Minnetonka, MN

6d•$130,000 - $150,000•Remote

About The Position

The Senior Process / Operations Engineer – Regulated Devices is responsible for overseeing contract manufacturing operations for a Class II FDA-regulated medical device used for capillary blood collection from a patient’s upper arm into a collection tube for laboratory diagnostic analysis. This role serves as the primary operational and technical liaison between internal teams and Contract Manufacturing Organizations (CMOs), ensuring manufacturing processes, product quality, and operational performance meet all regulatory, quality, and business requirements. The senior engineer will work cross-functionally with R&D, Quality, Regulatory Affairs, Supply Chain, and external manufacturing partners to support product commercialization, process scalability, validation, and continuous improvement initiatives. The ideal candidate has strong experience in medical device process engineering, supplier/CMO management, and regulated manufacturing environments with a deep understanding of FDA and ISO quality system requirements.

Requirements

Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, Manufacturing, or related field)
5+ 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
Strong understanding of process validation (IQ/OQ/PQ)
Strong understanding of FDA Quality System Regulations (21 CFR Part 820)
Strong understanding of ISO 13485
Strong understanding of CAPA and change control systems
Experience collaborating with Quality, Regulatory, and R&D teams in a regulated environment

Responsibilities

Serve as the 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, 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