Full-Time

Staff Design Quality Assurance Engineer

Updated on 6/5/2024

Hinge Health

Hinge Health

1,001-5,000 employees

Digital clinic for joint and muscle pain


Senior

San Francisco, CA, USA

Requirements
  • 6+ years of leading QMS initiatives and Design Controls with Risk Management within a medical device organization
  • Experience with creating processes compliant with 21 CFR 820, ISO 13485, ISO 14971
  • Experience in the design and development of software as medical device (SaMD) to IEC 62304 and medical electrical devices to IEC 60601
  • Experience in leading product initiatives from project team formation to product launch ready
  • Ability to engage, coach, and teach cross-functional team members regarding Quality System and medical device requirements
  • Travel 5-15%
Responsibilities
  • Lead Design Quality Engineering on cross-functional teams
  • Execute the product development process to design, verify and transfer high quality products to commercial launch
  • Recommend test methods and identify statistical methods for achieving required level of product quality and reliability
  • Proactively identify opportunities for improvements in areas of system compliance and product development
  • Drive compliance in risk management and usability engineering activities
  • Provide expertise and guidance to ensure compliance within designated projects and product lines
  • Serve as quality reviewer and approver for design control changes
  • Ensure compliance with the quality system and may own corrective actions (CAPA)

Hinge Health operates a digital clinic that specializes in treating joint and muscle pain, combining advanced motion technology with wearable pain relief solutions. The company’s unique HingeConnect platform connects with over a million in-person providers, promoting earlier interventions to potentially prevent unnecessary musculoskeletal surgeries. This emphasis on technological integration and proactive healthcare solutions provides a dynamic work environment that is at the forefront of digital health, making it an attractive workplace for innovators and healthcare professionals alike.

Company Stage

Series E

Total Funding

$1.2B

Headquarters

San Francisco, California

Founded

2014

Growth & Insights
Headcount

6 month growth

6%

1 year growth

15%

2 year growth

36%

Benefits

Competitive compensation with meaningful equity

Medical, Dental, Vision, Disability and Life Insurance (We cover 100% of your premium and 75% for your dependents)

Flexible PTO

FSA/HSA accounts

Family & fertility benefit through Maven Clinic

401(k) match

3 months paid parental leave

Professional Development budget

Quarterly lifestyle benefit to use towards WFH equipment & fitness

Generous mental health stipend

Work from home policy

Opportunity to join a fantastically talented, diverse, and passionate team at a pivotal time in the company's lifecycle