Overview:
About the Role
In this role as a Design Quality Assurance Engineer, you will have responsibility for leading Quality Management System (QMS), Design Controls, and Risk Management initiatives that are intended to expand Hinge Health’s medical device portfolio. The Design Quality Assurance Engineer is considered a subject matter expert in all aspects of product development and sustaining engineering processes while applying comprehensive knowledge of design controls and risk management to ensure the highest level of quality in new products, and their compliance to applicable regulatory standards.
What You'll Accomplish
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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.
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Execute the product development process to design, verify and transfer high quality products to commercial launch.
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Ensure product compliance to regulations, standards, and quality system by driving functional excellence in Design Assurance and championing activities to implement changes and improvements.
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Recommend test methods and identity statistical methods for achieving required level of product quality and reliability.
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Proactively identify opportunities for improvements in areas of system compliance and product development.
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Drive compliance in all aspects of risk management and usability engineering activities throughout the product life cycle.
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Provide expertise and guidance, within the scope of the quality system, to ensure compliance within designated projects and product lines.
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Serve as quality reviewer and approver for design control changes.
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Ensure compliance with the quality system and may own corrective actions (CAPA).
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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).
Hinge Health Hybrid Model
We believe that remote work and in-person work have their own advantages and disadvantages, and we want to be able to leverage the best of both worlds. Employees in hybrid roles are required to be in the office 3 days/week.
Qualificatons:
Basic Qualifications
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6+ years of leading QMS initiatives and Design Controls with Risk Management within a medical device organization
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Experience with creating processes, from scratch or significantly updated, compliant with 21 CFR 820, ISO 13485, ISO 14971
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Experience in the design and development of software as medical device (SaMD) to IEC 62304 and medical electrical devices to IEC 60601
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Experience in leading product initiatives from project team formation to project planning, execution and to product launch ready.
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Ability to engage, coach, and teach cross-functional team members regarding Quality System and medical device requirements
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Travel 5-15%
Preferred Qualifications
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Familiarity with international regulations and new market entry
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Bachelor’s or master’s degree in an engineering or other STEM discipline
Compensation
This position will have an annual salary, plus equity and benefits. Please note the annual salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. The annual salary range for this position is $144,000 - $216,000.
Company Information:
About Hinge Health
Hinge Health is moving people beyond pain by transforming the way it is treated and prevented. Connecting people digitally and in-person with expert clinical care, we combine advanced technology, AI and a care team of experts to guide people through personalized care directly from their phone. Our approach is proven to reduce pain by 68%, prevent 42% of new opioid prescriptions, and avoid more than half of joint replacement surgeries. Available to 18M people, Hinge Health is trusted by leading health plans and employers, including Land O’Lakes, L.L. Bean, Salesforce, Self-Insured Schools of California, Southern Company, City of Boston, US Foods, and Verizon.
Learn more at http://www.hingehealth.com
What You'll Love About Us
Inclusive healthcare and benefits: On top of comprehensive medical, dental, and vision coverage, we offer employees and their family members help with gender-affirming care, tools for family and fertility planning, and travel reimbursements if healthcare isn’t available where you live.
Planning for the future: Start saving for the future with our traditional or Roth 401k retirement plan options which include a 2% company match.
Modern life stipends: Manage your own learning and development
Diversity and Inclusion
We’re committed to building diverse teams that reflect the communities we serve. Visit hingehealth.com/diversity-equity-and-inclusion to learn more about what moves us.
Hinge Health is an equal opportunity employer and prohibits discrimination and harassment of any kind. We make employment decisions without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran status, disability status, pregnancy, or any other basis protected by federal, state or local law. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
We provide reasonable accommodations for candidates with disabilities. If you feel you need assistance or an accommodation due to a disability, let us know by reaching out to your recruiter.