Senior Process & Operations Engineer

The Senior Process / Operations Engineer is responsible for overseeing contract manufacturing operations for a Class II FDA-regulated medical device. 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.

What You Will Do

The ideal candidate will oversee day-to-day manufacturing performance, quality metrics, and operational execution at CMOs, develop and optimize manufacturing processes, and drive accountability with manufacturing partners.

Why It Might Be a Fit

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)
• 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, and 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