Senior Design Assurance Engineer – Med Device (Remote)

Socket.dev; Minnetonka (MN); Hybrid; USD 120,000 - 150,000; Full time

Benefits offered by this job

Competitive salary & equity

Unlimited PTO

Health benefits

ESPP

Employee discounts

401k benefits

Offsite team retreats

Job summary

Hims & Hers is seeking a Sr. Design Assurance Engineer to support sustaining and new product design, ensuring smooth transfer to manufacturing. The role runs in a fast-paced, growth-focused environment with cross-functional collaboration.

You will apply problem-solving methodologies, contribute to risk management and design controls, and develop technical documentation while supporting post-market activities and design changes. A strong quality mindset and communication skills are essential.

Qualifications

• Bachelor's degree in mechanical or biomedical engineering (or related technical discipline).
• 5-8+ years of experience in design assurance or related medical device industry.
• Self-motivated with 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 sound problem-solving methodologies to identify and resolve quality issues.
• Support quality disciplines, decisions, and practices in cross-functional settings.
• Work with cross-functional teams to implement controls for Class II medical devices.
• 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 to analyze and assess changes.
• Apply validation and statistical techniques per regulatory requirements and internal standards.
• Support verification, validation, and usability testing to meet requirements.
• Develop and maintain Design History File and Design Input/Output documentation.
• Generate and maintain product risk management tools (Hazard Analysis, FMEAs).
• Partner with R&D to determine and implement Design Controls based on Risk Management and Manufacturing Input.
• Collaborate cross-functionally to support value-improvement initiatives.

Skills

Problem solving

Cross-functional collaboration

Communication skills

Design controls

Education

Bachelor's degree in mechanical or biomedical engineering

Tools

Quality tools/methodologies

Job description

Hims & Hers is seeking a Sr. Design Assurance Engineer to support sustaining and new product design, ensuring smooth transfer to manufacturing. The role runs in a fast-paced, growth-focused environment with cross-functional collaboration.

You will apply problem-solving methodologies, contribute to risk management and design controls, and develop technical documentation while supporting post-market activities and design changes. A strong quality mindset and communication skills are essential.