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Sr. Process & Operations Engineer
Hims & HersTelemedicine company
Minnetonka, United StatesSenior
Thrive Capital
Forerunner Ventures
8VC
About the role
TL;DR
Oversee contract manufacturing for regulated medical devices, ensuring quality and operational performance.
- •The Senior Process / Operations Engineer
- •Regulated Devices 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).
- •Key Responsibilities Oversee day-to-day manufacturing performance, quality metrics, and operational execution at CMOs.
- •Develop, optimize, and sustain manufacturing processes for Class II medical devices and consumables.
- •Ensure all manufacturing activities comply with FDA Quality System Regulations, ISO 13485, and GMP requirements.
- •Drive continuous improvement initiatives using Lean, Six Sigma, or similar methodologies.
- •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).
Required skills
JiraConfluenceGit
Domain expertise
healthtech
Benefits & perks
Competitive salary & equity compensation, Unlimited PTO, Company holidays, Quarterly mental health days, Comprehensive health benefits, Medical, dental & vision, Parental leave, Employee Stock Purchase Program (ESPP), Employee discounts, 401k benefits with employer matching contribution, Offsite team retreats
Tech stack
PythonSQLJiraConfluenceGit