Lead Software Design Quality Engineer @ Whoop

INACTIVE

Full-Time

Lead Software Design Quality Engineer

Whoop

501-1,000 employees

Wearable performance & optimization technology

Hardware

Consumer Goods

Senior

Cambridge, MA, USA

Requirements

Bachelor's Degree in Engineering, Biomedical Engineering, Computer Science, or related technical field, or equivalent practical experience
5+ years of experience in software design quality engineering in the medical device industry
Deep experience with the application of IEC 62304 (Medical Device Software Lifecycle Processes), AAMI TIR45, ISO 14791 (Risk Management), and IEC 62366 Usability Engineering principles and requirements
Leads by doing and demonstrates leadership and teamwork in a collaborative cross-functional environment
Excellent organizational, interpersonal, verbal, and written communication skills
Passion for delivering impactful and high-quality products to people
Nice to Have: Experience with Consumer Wearable Products, General Wellness Products, Digital Health, mobile medical applications, or Medical Device Data Systems (MDDS)
Nice to Have: Experience with Machine Learning medical device technologies in an ambiguous, fast-paced, and innovative environment

Responsibilities

Lead ongoing implementation and execution of the SDLC process in conformance with US FDA Quality System Regulations, IEC 62304, and ISO 13485 Design Controls
Act as a Design Quality team member for Software as a Medical Device (SaMD) projects
Support the Medical Device Team in the creation and approval of Design History Files (DHFs), including design and development plans, verification and validation plans, software requirements specification, software architecture, design reviews, Risk Management File (RMF), and traceability matrices
Lead and conduct risk management activities, including system risk analysis and software FMEAs
Provide medical device software development expertise for SaMD projects in the areas of Regulatory Compliance, Design Control, Usability Engineering, and Risk Management as needed
Foster organizational compliance to the quality system, including ongoing training and education on software QMS and SDLC frameworks
Drive integration of ISO 14971 risk management and IEC 62366 usability engineering activities with SDLC processes
Support QMS improvements and internal/external regulatory inspections

At WHOOP, we’re on a mission to unlock human performance. WHOOP empowers members to perform at a higher level through a deeper understanding of their bodies and daily lives.

WHOOP is seeking a Lead Software Design Quality Engineer (Medical Devices) to navigate and manage regulatory and quality processes in support of product development for Medical Device Software, including the implementation and execution of a Software Development Lifecycle (SDLC) process in alignment with US FDA Quality System Regulations and Design Controls. In this role, you will work with the WHOOP Medical Device Team to act as a champion of Quality Assurance and Regulatory activities throughout the SDLC process.

As a Lead Software Design Quality Engineer, you will be responsible for various quality functions in support of product development for Medical Software, such as leading Risk Management activities, collaborating with the WHOOP Medical Device Team throughout the SDLC, mentoring team members through Design controls, and ensuring compliance with the Quality Management System (QMS). You will hold yourself and the team accountable for developing best-in-class, safe, and effective medical devices that address customer and regulatory requirements. Additionally, you will need to bring best practices and creative problem-solving abilities to support high-speed medical development in a consumer wearable company.

This role reports to the Director of Quality and Regulatory Affairs.

RESPONSIBILITIES:

Lead ongoing implementation and execution of the SDLC process in conformance with US FDA Quality System Regulations, IEC 62304, and ISO 13485 Design Controls
Act as a Design Quality team member for Software as a Medical Device (SaMD) projects
Support the Medical Device Team in the creation and approval of Design History Files (DHFs), including design and development plans, verification and validation plans, software requirements specification, software architecture, design reviews, Risk Management File (RMF), and traceability matrices
Lead and conduct risk management activities, including system risk analysis and software FMEAs
Provide medical device software development expertise for SaMD projects in the areas of Regulatory Compliance, Design Control, Usability Engineering, and Risk Management as needed.
Foster organizational compliance to the quality system, including ongoing training and education on software QMS and SDLC frameworks.
Drive integration of ISO 14971 risk management and IEC 62366 usability engineering activities with SDLC processes.
Support QMS improvements and internal/external regulatory inspections

QUALIFICATIONS:

Bachelor’s Degree in Engineering, Biomedical Engineering, Computer Science, or related technical field, or equivalent practical experience
5+ years of experience in software design quality engineering in the medical device industry
Deep experience with the application of IEC 62304 (Medical Device Software Lifecycle Processes), AAMI TIR45, ISO 14791 (Risk Management), and IEC 62366 Usability Engineering principles and requirements
Leads by doing and demonstrates leadership and teamwork in a collaborative cross-functional environment
Excellent organizational, interpersonal, verbal, and written communication skills
Passion for delivering impactful and high-quality products to people
Nice to Have: Experience with Consumer Wearable Products, General Wellness Products, Digital Health, mobile medical applications, or Medical Device Data Systems (MDDS)
Nice to Have: Experience with Machine Learning medical device technologies in an ambiguous, fast-paced, and innovative environment

Interested in the role, but don’t meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply.

WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility.

Whoop

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Website

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Whoop’s mission is to unlock human performance though tapping into every individual owner's potential which can be enhanced through continuous monitoring. The company has built a system across hardware, software, and analytics designed to collect and analyze the most important data on the human data.

Company Stage

Series F

Total Funding

$406.1M

Headquarters

Boston, Massachusetts

Founded

2012

Growth & Insights

Headcount

6 month growth

↑ 15%

1 year growth

↑ 39%

2 year growth

↑ 12%

Benefits

Take Time Off: Time outside of the office is important for sleep, strain and recovery! Our PTO plan encourages members to take time off in order to come back refreshed.

Live a Healthy Lifestyle: Our competitive benefits package includes premium medical, dental, and vision coverage for employees and their dependents. Life and disability insurance are also available.

Feel Invested: In addition to a competitive base salary and 401k, you're eligible to receive stock options to share in the future of WHOOP. Work means more when you have personal stake. You have ownership in what we are building.

Eat Well: Keep hunger at bay with endless snacks in our fully stocked kitchen. Enjoy catered team lunches on Friday, and even a cold brew keg.

Know The Product: We want you to understand and experience the product firsthand. We offer you a WHOOP strap and membership at no cost.

Be Active: Take advantage of our office gym and on-site showers! WHOOP also offers a $500 yearly wellness perk for fitness classes and memberships.

Be Present: It’s important to be present when bringing home a new family member. Take care of your loved ones with 12 weeks paid parental leave, plus an additional 2 weeks to gradually return to work.

Love Where You Work: Sitting in the heart of Fenway, our beautiful office overlooks Fenway Park. A prime location for great food, not to mention catching a Sox game, too!

Work Hard, Play Harder: If we don't already have a club here that fits your lifestyle and interests, you're encouraged to start one. Share your passions with others at work, or discover new ones!

INACTIVE