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Hinge Health · 2 days ago
Staff Design Quality Assurance Engineer
San Francisco, CA
Full-time
Onsite
Senior Level
$144K/yr - $216K/yr
6+ years exp
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Responsibilities
Lead Design Quality Engineering on cross-functional teams, interfacing among multiple departments and teams such as Software/Hardware/Firmware Engineering, Regulatory Affairs, Operations, Supply Chain, and Project Management.
Execute the product development process to design, verify and transfer high quality products to commercial launch.
Ensure product compliance to regulations, standards, and quality system by driving functional excellence in Design Assurance and championing activities to implement changes and improvements.
Recommend test methods and identity 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 all aspects of risk management and usability engineering activities throughout the product life cycle.
Provide expertise and guidance, within the scope of the quality system, 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).
Qualification
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Required
6+ years of leading QMS initiatives and Design Controls with Risk Management within a medical device organization
Experience with creating processes, from scratch or significantly updated, 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 project planning, execution and to product launch ready.
Ability to engage, coach, and teach cross-functional team members regarding Quality System and medical device requirements
Preferred
Familiarity with international regulations and new market entry
Bachelor’s or master’s degree in an engineering or other STEM discipline
Travel 5-15%
Benefits
Comprehensive medical, dental, and vision coverage
Help with gender-affirming care
Tools for family and fertility planning
Travel reimbursements for healthcare
Traditional or Roth 401k retirement plan with a 2% company match
Modern life stipends for learning and development
Company
Hinge Health
Hinge Health is a digital clinic for joint, and muscle care, pelvic pain, bowel, and bladder control.
1,001-5,000 employees
H1B Sponsorship
Hinge Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (8)
2022 (24)
2021 (17)
2020 (5)
Funding
Current Stage
Late StageTotal Funding
$826.13MKey Investors
Bessemer Venture PartnersInsight PartnersAtomico
2021-10-28Series E· $400M
2021-10-28Secondary Market· Undisclosed
2021-01-07Series D· $300M
Leadership Team
Daniel Perez
Co-Founder, CEO
Gabriel Mecklenburg
Co-founder, Executive Chairman
Recent News
2024-05-28
Company data provided by crunchbase
