Senior Design Quality Engineer

Company Description

Founded by Dr. Jonathan Rothberg in 2011, Butterfly Network is a digital health company with a mission is to democratize medical imaging by making high-quality ultrasound affordable, easy-to-use, globally accessible, and intelligently connected, including for the 4.7 billion people around the world lacking access to ultrasound. Butterfly created the world's first handheld single-probe, whole-body ultrasound system using semiconductor technology, Butterfly iQ.

The company has continued to innovate, leveraging the benefits of Moore’s Law, to launch its second generation Butterfly iQ+ in 2020, and third generation iQ3 in 2024 – each with increased processing power and performance enhancements.

The disruptive technology has been recognized by TIME’s Best Inventions, Fast Company’s World Changing Ideas, CNBC Disruptor 50, and MedTech Breakthrough Awards, among other accolades. With its proprietary Ultrasound-on-Chip™ technology, intelligent software, and educational offerings, Butterfly is paving the way to mass adoption of ultrasound for earlier detection and remote management of health conditions around the world.

Joining Butterfly is the opportunity to redesign the future of healthcare through the power of technology. Embark on a journey with us to maximize global impact, motivated by the idea that our products will change the lives of millions, along with the people you love.

Job Description

The Senior Design Quality Engineer will be responsible for supporting new hardware and software medical device product development and sustaining product line activities as the Design Quality Project Lead for cross-functional teams . This position reports to [Senior Manager, Quality Engineering]. This individual will interact on a daily basis with R&D, Program Management, Manufacturing Operations/Engineering, Quality Management Systems, Regulatory, Clinical, and Marketing to drive quality into the product design, advise cross-functional teams on design controls, risks and mitigations, and communicate quality metrics to continually improve and promote compliance to Butterfly’s QMS procedures as well as applicable laws, regulations and standards.This position contributes to the development, establishment and maintenance of design controls, quality engineering methodologies, systems and practices which meet Butterfly Network’s and Regulatory Agency’s requirements.

As part of our team, your core responsibilities will be:

• Execute, analyze and suggest improvements to Quality Management System processes, especially in relation to the Design Controls Lifecycle Process
• Create and maintain Product Risk File
• Guiding cross functional teams on how to create and modify design quality characteristics, including manufacturability, architecture,serviceability, testability, reliability, and product require
• Leading Risk Management Meetings with cross-functional team to understand product hazards and develop mitigations.
• Partnering with the post-market surveillance team to drive improvements for sustaining products and to establish a risk management process throughout a product’s lifecycle
• Assess risk of identified product defects and triage remediation
• Ability to comprehend principles of engineering,cybersecurity, physiology and medical device use
• Review Product Design Documentation
• Proactively communicates quality issues to cross functional teams and leadership.
• Participates in Quality Review Board and Change Control Review Board meetings
• Provide guidance and direction for sample size and statistical analysis of Verification and Validation testing
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving product and quality issues
• Support Internal and External Audits of Product Design Documentation
• Provide training to project teams on all Quality Policies / Procedures (including verification, validation, statistical methods,design controls), when necessary
• Ensuring all Butterfly products meet and exceed customer needs as well as complies with FDA regulations, other regulatory requirements, Company operating procedures, processes, and task assignments
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers/vendors
• Contributes to the development, maintenance, and improvement of Butterfly Network’s design control process, system, and procedures
• Performs other related duties and responsibilities, as assigned

Qualifications

Baseline skills/experiences/attributes:

• BS degree in Engineering or Technical Field or equivalent experience
• Min 5 years of Medical Device Design Quality experience
• Ability to work in a geographically diverse business environment
• Ability to operate in an electronic Quality Management System
• Ability to leverage and/or engage others to accomplish projects
• Ability to work independently as a Design Quality Project Lead for Products
• Experience with root cause identification and problem solving
• Strong organizational and follow-up skills, as well as attention to detail
• Ability to work in a timeline driven environment
• Excellent interpersonal and communication skills, both written and oral to effectively communicate at multiple levels in the organization
• Working Knowledge of current Regulations and Guidelines such as: GMP, ISO 13485; ISO 14971, FDA 21 CFR Part 820; (EU) 2017/745 (MDR), IEC 62304, IEC 62366-1, IEC 60601, TIR-57
• Knowledge of Waterfall and Agile methodology best practices
• Strong Knowledge of Statistical Methods
• Strong Understanding of SW Development and release lifecycle, SW Architecture, and Configuration Management
• Proficient with software development and collaboration tools (e.g., Jira, JAMA, GitHub)
• Experience with SaMD, AI/ML, cloud-hosted, digital health, or mobile app medical devices
• ASQ (or equivalent) CQA, CQE or other certifications preferred
• Participate or Lead Medical Device Product or Process Audits (May require Travel)

Location

Our offices offer kitchens stocked with snacks and beverages, comfortable work stations, and multiple opportunities to collaborate with your colleagues to build community.

This is an in-office position and will be based out of our office in Taiwan.

Benefits and Perks

We offer great perks:

• Basic insurance through the Taiwan government - as a health-tech company, we place great worth on our teams’ well-being
• Kitchen stocked with snacks
• Beautiful office in the tech hub of Taiwan
• Competitive salaried compensation - we value our employees and show it
• Equity - we want every employee to be a stakeholder
• Generous holiday calendar - we encourage employees to celebrate throughout the year
• Team-building social events throughout the year (e.g. New Year, Mid-Autumn Festival, etc.)
• The opportunity to build a revolutionary healthcare product and save millions of lives!

For this role, we are only considering candidates who are legally authorized to work in Taiwan and who do not now or in the future require sponsorship for employment visa status.

Butterfly network does not accept agency resumes.

Butterfly Network Inc. is an E-Verify Company.

Butterfly Network is an equal opportunity employer. Regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.

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