# Sr. Process & Operations Engineer

Hiring organization: [Hims and Hers](https://career.thegoodapps.co/organizations/hims-and-hers)

Canonical page: https://career.thegoodapps.co/jobs/62de5956-c79d-486a-8e02-aad6e4eb15aa

Listed on Hims and Hers's own careers site. Applications go to them directly.

- Employment type: full time
- Seniority: Senior
- Location: Minnetonka, MN
- Salary: 130000 – 150000 USD per year

## Summary

This role oversees contract manufacturing operations for FDA-regulated medical devices, serving as the technical liaison between internal teams and external manufacturers. It suits experienced process engineers with deep medical device manufacturing expertise who can manage complex regulatory compliance and drive operational excellence across suppliers.

_Our summary, not Hims and Hers's wording._

## Skills named

Change Control, Corrective And Preventive Action (CAPA), ISO 13485, Lean, Process Validation, Six Sigma

## Required

- Bachelor's degree in Engineering (Mechanical, Biomedical, Industrial, Manufacturing, or related field)
- 8+ years in process engineering, operations engineering, or manufacturing engineering in medical device or diagnostics industry
- Experience supporting Class II FDA-regulated medical devices in GMP manufacturing environment
- Direct experience managing or working with Contract Manufacturing Organizations (CMOs)
- Strong understanding of design controls, process validation, FDA regulations, ISO 13485, CAPA and change control systems
- Ability to collaborate with Quality, Regulatory, and R&D teams in regulated environments
- Medical clearance to wear respiratory protection
- Ability to work with hazardous drugs and wear required PPE
- Physical capability to walk up to 50%, stand up to 100%, squat and bend up to 20%, and lift up to 50 lbs for up to 12-hour shifts

Apply on Hims and Hers's site: https://jobs.ashbyhq.com/hims-and-hers/8842e5bb-4556-46e1-a39b-64bc294c977a/application