Sr. Process & Operations Engineer

About the role

This role involves overseeing the manufacturing of a Class II FDA-regulated medical device. You will act as the main operational and technical link between internal teams and external contract manufacturers. Your work will ensure that production processes, product quality, and operational efficiency meet all necessary regulatory, quality, and business standards.

Key facts

What you'll do

• Lead technical operations for external contract manufacturers and key suppliers.
• Monitor daily manufacturing performance, quality metrics, and operational execution at Contract Manufacturing Organizations (CMOs).
• Confirm manufacturing processes consistently meet product specifications, quality standards, and production goals.
• Hold manufacturing partners accountable for timelines, deviations, corrective and preventive actions (CAPAs), and continuous improvement efforts.
• Create, refine, and maintain manufacturing processes for Class II medical devices and related consumables.
• Collaborate with Research & Development during 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.
• Investigate root causes and implement CAPAs for manufacturing or process issues.
• Track process performance to find opportunities for yield improvement, cost reduction, and operational efficiency.
• Ensure all manufacturing activities adhere to FDA Quality System Regulations (21 CFR Part 820), ISO 13485, GMP requirements, and internal quality system procedures.
• Work closely with Quality Assurance to resolve nonconformances, deviations, change controls, and audit findings.
• Assist with supplier qualification, audits, and ongoing supplier quality management.
• Verify that manufacturing documentation, Device History Records (DHRs), and validation records are complete and compliant.
• Partner with Research & Development to transition new products into commercial manufacturing.
• Work with Supply Chain and Planning teams to support production schedules, inventory, and demand forecasting.
• Support Regulatory Affairs with manufacturing documentation for submissions and inspections.
• Coordinate with Packaging, Sterilization, and Logistics teams for smooth product release and shipment.
• Establish and monitor Key Performance Indicators (KPIs) for manufacturing quality, throughput, scrap, and supplier performance.
• Drive continuous improvement using methodologies like Lean or Six Sigma.
• Help implement scalable operational processes as the company expands.
• Assist with risk assessments and mitigation for manufacturing and supply continuity.

Requirements

• Bachelor's degree in Engineering (Mechanical, Biomedical, Industrial, Manufacturing, or a related field).
• 8 or more years of experience in process, operations, 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 closely collaborating 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, and CAPA and change control systems.
• Experience collaborating with Quality, Regulatory, and Research & Development teams in a regulated environment.

Practical notes

This position requires working with Hazardous Drugs (HD), necessitating the use of Personal Protective Equipment (PPE) such as gloves, respiratory protection, and gowns. Medical approval to wear various respirators (N95, full face, SCBA, PAPR) is required. The role involves physical exertion, including walking up to 50% of the time, standing up to 100%, squatting and bending up to 20%, and lifting up to 80% of the time for a twelve-hour shift, with the ability to lift up to 50lbs. Associates must confirm understanding of potential risks (teratogenicity, carcinogenicity, reproductive effects) of handling hazardous drugs. Benefits include competitive salary and equity, unlimited PTO, comprehensive health benefits, an Employee Stock Purchase Program (ESPP), employee discounts, 401k with employer matching, and offsite team retreats.