Sr. Process & Operations Engineer

Hims & Hers•Boston, MA

1d•$130,000 - $150,000

About The Position

The Senior Process / Operations Engineer – Regulated Devices oversees contract manufacturing operations for a Class II FDA-regulated medical device used for capillary blood collection for laboratory diagnostic analysis. The role is the primary operational and technical liaison between internal teams and Contract Manufacturing Organizations (CMOs), ensuring manufacturing processes, product quality, and operational performance meet regulatory, quality, and business requirements. The engineer works cross-functionally with R&D, Quality, Regulatory Affairs, Supply Chain, and external manufacturing partners to support commercialization, scalability, validation, and continuous improvement. The position covers CMO performance and supplier oversight, manufacturing process development and support, validation and verification, quality and regulatory compliance, cross-functional production coordination, and operational excellence. It includes work with hazardous drugs and requires wearing appropriate PPE, including respiratory protection where required. Medical approval is required to wear respiratory protection. The role also involves specified physical exertion, including standing, walking, bending, squatting, and lifting up to 50 pounds.

Requirements

Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, Manufacturing, or a related field).
At least 8 years of experience in process engineering, operations engineering, or manufacturing engineering in 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.
Medical approval to wear respiratory protection, including negative- or positive-pressure respirators, is required.
Must be able to wear required PPE when working with hazardous drugs.
Must be able to lift up to 50 pounds and perform the stated physical activities.
Must be willing to confirm understanding of potential teratogenic, carcinogenic, and reproductive risks from handling or compounding certain hazardous drugs.

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 meet product specifications, quality standards, and production targets.
Drive manufacturing partner accountability for timelines, deviations, CAPAs, and continuous improvement initiatives.
Develop, optimize, and sustain manufacturing processes for Class II medical devices and consumables.
Partner with R&D on product development and design transfer to ensure manufacturability and scalability.
Support process characterization, validation, and verification, including IQ/OQ/PQ validation, process capability studies, equipment qualification, and manufacturing line readiness.
Lead root cause investigations and implement corrective and preventive actions related to manufacturing or process issues.
Monitor process performance and identify opportunities for yield improvement, cost reduction, and operational efficiency.
Ensure manufacturing activities comply with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, GMP requirements, and internal quality system procedures.
Collaborate with Quality Assurance on nonconformances, deviations, change controls, and audit findings.
Support supplier qualification, supplier audits, and ongoing supplier quality management.
Ensure manufacturing documentation, Device History Records (DHRs), and validation records are complete and compliant.
Coordinate with R&D to transition products from development into commercial manufacturing.
Partner with Supply Chain and Planning on production schedules, inventory management, and demand planning.
Support Regulatory Affairs with manufacturing documentation for regulatory submissions and inspections.
Coordinate with Packaging, Sterilization, and Logistics teams on product release and shipment readiness.
Establish and monitor KPIs related to manufacturing quality, throughput, scrap, and supplier performance.
Drive continuous improvement using Lean, Six Sigma, or similar methodologies.
Support scalable operational processes and assist with manufacturing and supply continuity risk assessments and mitigation.
Wear required PPE when working with hazardous drugs and meet the stated respiratory-protection and physical requirements.