Senior Design QA Engineer - Medical Devices (Remote/Hybrid)

hims & hers; Minnetonka (MN); Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

Competitive salary & equity

Unlimited PTO and holidays

Comprehensive health benefits

ESPP

Employee discounts on products

401k with matching

Offsite team retreats

Job summary

Hims & Hers is seeking a Sr. Design Assurance Engineer to support sustaining and new product development activities, ensuring smooth transfer to manufacturing.

You will work in a fast-paced, growth-focused environment where initiative and cross-functional collaboration are key. You will apply problem-solving methods to identify and resolve quality issues, support Design Controls and Risk Management, and contribute to post-market activities.

Qualifications

• Bachelor's degree in mechanical or biomedical engineering or related technical discipline.
• 5–8+ years of design assurance, new product development, or related medical device experience.
• Self-motivated with a passion for solving problems and a bias for action.
• Strong communication skills (verbal & written).
• Demonstrated use of Quality tools/methodologies.
• Ability to effectively work and collaborate in a mixed onsite + remote environment.
• Demonstrated experience creating detailed technical documents.

Responsibilities

• Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Support quality disciplines, decisions, and practices within cross-functional teams.
• Identify and implement controls for Class II medical devices.
• Write technical documentation for procedures, rationale, and development evidence.
• Support Risk Management, Design Controls, and other DA priorities.
• Participate in Post Market activities based on risk signals.
• Contribute to Design Change analyses to assess proposed product changes.
• Apply validation techniques to meet regulatory and internal standards.
• Support verification, validation, and usability testing to meet requirements.
• Develop and maintain Design History File and related documentation.
• Maintain product risk management tools (Hazard Analysis, FMEAs).
• Collaborate with R&D to implement Design Controls based on risk and customer needs.

Skills

Design Assurance

Quality Tools

Cross-functional teamwork

Documentation

Risk Management

Education

Bachelor's degree in mechanical or biomedical engineering

Tools

FMEA

Job description

Hims & Hers is seeking a Sr. Design Assurance Engineer to support sustaining and new product development activities, ensuring smooth transfer to manufacturing.

You will work in a fast-paced, growth-focused environment where initiative and cross-functional collaboration are key. You will apply problem-solving methods to identify and resolve quality issues, support Design Controls and Risk Management, and contribute to post-market activities.