Senior Design Assurance Engineer, Medical Devices

Hims, Inc.; Minnetonka (MN); Hybrid; USD 120,000 - 155,000; Full time

Benefits offered by this job

Competitive salary & equity

Unlimited PTO & holidays

Comprehensive health benefits

401k with employer matching

Employee stock purchase program

Offsite team retreats

Job summary

Hims, Inc. is seeking a Sr. Design Assurance Engineer to join the Device Quality team. You will support sustaining and new product development, ensuring smooth transfer to manufacturing and compliant design controls for Class II medical devices.

You will partner with R&D and cross-functional teams to manage risk, document development processes, and drive usability and validation testing to meet regulatory standards.

Qualifications

• Bachelor’s degree in mechanical or biomedical engineering or related technical discipline.
• 5-8+ years in design assurance, new product development or medical device/regulatory industry.
• Self-motivated with bias for action and problem solving.
• Strong verbal and written communication skills.
• Experience using quality tools/methodologies.
• Ability to work effectively in mixed onsite + remote environment.
• Experience creating detailed technical documents.

Responsibilities

• Apply systematic problem-solving to identify, prioritize, communicate, and resolve quality issues.
• Support quality disciplines and cross-functional decisions.
• Identify and implement controls for Class II medical devices across a cross-functional team.
• Write technical documentation for procedures, rationale, and development evidence.
• Support Design Assurance activities related to Risk Management and Design Controls.
• Support Post Market activities based on post-market signals.
• Participate in the Design Change process for thorough analysis of product changes.
• Demonstrate use of validation and statistical techniques per regulatory requirements and internal standards.
• Support verification, validation, and usability testing to meet internal and external requirements.
• Develop, update, and maintain Design History File and related documentation.
• Generate and maintain product risk management tools (Hazard Analysis, Fault Tree, FMEAs).
• Partner with R&D to implement Design Controls based on Risk Management and Customer needs.
• Collaborate cross-functionally to support value improvement initiatives.

Skills

Problem solving

Quality tools

Cross-functional collaboration

Documentation skills

Hybrid/onsite collaboration

Education

Bachelor's degree in mechanical or biomedical engineering

Tools

Design Controls

FMEAs

Risk Analysis

Job description

Hims, Inc. is seeking a Sr. Design Assurance Engineer to join the Device Quality team. You will support sustaining and new product development, ensuring smooth transfer to manufacturing and compliant design controls for Class II medical devices.

You will partner with R&D and cross-functional teams to manage risk, document development processes, and drive usability and validation testing to meet regulatory standards.