Sr. Engineer, Design Quality Assurance

Hims & Hers • Minnetonka, MN

22h • $140,000 - $160,000 • Hybrid

About The Position

The Sr. Design Assurance Engineer, reporting to the Director of Device Quality, supports sustaining and new product design and development activities and ensures the effective transfer of new products into manufacturing. We are looking for a strong engineer who enjoys working in a fast paced and rapidly growing environment where taking initiative and collaborating cross-functionally are critical for success.

Requirements

• Minimum of a bachelor’s degree in mechanical or biomedical engineering (or other related technical discipline).
• 5 - 8+ years of experience in design assurance, new product development or related medical device / regulated industry 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.

Nice To Haves

• Experience in development and/or manufacturing of Class II medical devices
• ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis.
• Experienced problem solver, capable of facilitating the problem-solving process.
• Adaptable and effective collaborator in a team environment or in self-directed work.
• Experience with design changes, complaint management, and corrective action.

Responsibilities

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Acts as an effective team member in supporting quality disciplines, decisions, and practices.
• Work within a cross-functional team to identify and implement effective controls for realization of Class II medical devices.
• Write various technical documentation for procedure execution, technical rationale, and evidence of the development process.
• Support Design Assurance activities as related to Risk Management, Design Controls, and other DA related priorities.
• Support Post Market activities, as necessary, of risk based on post-market signals.
• Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed.
• Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatory requirements and internal standards.
• Support the verification, validation, and usability testing to meet or exceed internal and external requirements.
• Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
• Generate, update, and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs).
• Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
• Partner cross-functionally to identify and support value improvement efforts to support business goals.

Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• Employee discounts on hims & hers & Apostrophe online products
• 401k benefits with employer matching contribution
• Offsite team retreats

What This Job Offers

• Job Type: Full-time
• Career Level: Senior