Staff Supplier & Manufacturing Quality Engineer

Company Description

At Butterfly Network, we're leading a digital revolution in medical imaging, transforming an industry that has long relied on bulky, analog systems. With our proprietary Ultrasound-on-Chip technology, we're democratizing healthcare by shifting ultrasound from the expensive, stationary systems of the past to the connected, mobile, and software-enabled platforms of today. In 2018, we launched the world's first handheld, whole-body ultrasound, Butterfly iQ - followed by iQ+ in 2020 and iQ3 in 2024, each more powerful than the last.

Our innovation doesn't stop at hardware. Butterfly combines our advanced device with intelligent software, AI, services, and education to drive adoption of affordable, accessible imaging. Our technology is proving to help clinicians, clinics, and hospitals enhance care, cut costs, and expand imaging access. We've been recognized by Prix Galien USA, Fierce 50, TIME's Best Inventions, Fast Company's World Changing Ideas, among other awards.

We're a team of bold thinkers, problem-solvers, and innovators ready to shape the future of medical imaging. Let's build something extraordinary together!

Job Description

The Supplier & Manufacturing Quality Manager will be responsible for owning all activities related to supplier re-evaluation, onsite auditing, and remediation/resolution of quality-related issues, and process improvements. This position is also responsible for supporting supplier selection, evaluation & qualification, monitoring & management of supplier performance and relationship. This position is a process manager role with no direct reports that contributes to the development, establishment and maintenance of supplier controls, supplier quality engineering methodologies, systems and practices which meet Butterfly Network's and Regulatory Agency's requirements.

This position reports to the Senior Manager of Quality Engineering and collaborates closely with Manufacturing Operations/Engineering, Design Quality, Quality Management Systems.

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

• Reviews and approves all supplied product drawings and component quality plans
• Manages the development of supplied product inspection procedures and first article requirements
• Assesses supplier capabilities through quality system audits
• Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests, and technical discussions
• Participates in Quality Review Board and Change Control Review Board meetings
• Monitors supplier performance
• Applies sound engineering analysis and judgment to reduce the need for inspection in accordance with program policies
• Works with Manufacturing engineering to assess and address product issues
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Process optimization and/or improvement
• Mitigates risk by working with the Suppliers to document Process Flow Charts, PFMEAs, Control Plans, and IQ/OQ/PQ documentation
• Complies with FDA regulations, other regulatory requirements, Company policies, 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 supplier quality program, 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 Supplier 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
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Ability to work independently and manage the electronic Supplier Quality Management System in Trackwise Digital QMS.
• Experience with root cause identification and problem solving
• Strong organizational and follow-up skills, as well as attention to detail
• Excellent interpersonal skills with the ability to mentor
• Ability to work in a timeline driven environment
• Excellent communication skills, both written and oral
• Working Knowledge of current Regulations and Guidelines such as: GMP, ISO 13485; ISO 14971, FDA 21 CFR Part 820; (EU) 2017/745 (MDR)
• ASQ (or equivalent) CQA, CQE or other certifications preferred
• Ability to travel internationally
• Ability to obtain a Visa for travel to China

Values

Innovation is what we do. Our values are how we make it happen. Butterflies are and believe in...

• Patient-Centric Innovators: Our mission is THE mission.
• Empowered to Impact: Every voice matters.
• One Team, One Goal: Unity fuels progress.
• Growth Champions: We embrace challenges.
• Action-Oriented Achievers: We follow through, every time.

Location

Butterfly offers a hybrid work model for most positions, with team members spending two or more days a week in the office. While flexibility is key, we value in-person connections that spark creativity and teamwork. Our offices are designed for collaboration, with comfortable workspaces, stocked kitchens, and opportunities to connect with peers.

This is a hybrid position and will be based out of our office in New York City, NY or our office in Burlington, MA.
Benefits and Perks

• Comprehensive health insurance, encompassing dental and vision coverage, is provided to all our employees. As a health-tech company, we prioritize the well-being of our teams. Additionally, employees have the option to buy up for enhanced health insurance coverage. We also contribute to Health Savings Account (HSA) accounts for all enrolled employees on an annual basis.
• Comprehensive Employee Assistance Program - we provide access to tools and resources to support your emotional health and day-to-day needs.
• 401k plan and match - we facilitate your retirement goals.
• Eligible employees will have the opportunity to participate in Employee Stock Purchase Plan (ESPP)
• Unlimited Paid Time Off + 10 Holiday Days a Year - recharge and come back ready to make an impact
• Parental Leave - we aim to provide our employees with time to bond with their growing family, along with additional support for primary caregivers to help transition back to work
• Competitive salaried compensation - we value our employees and show it
• Equity - we want every employee to be a stakeholder
• The opportunity to build a revolutionary healthcare product and save millions of lives!

Compensation

Our estimated salary for this role is between $125,000 - $145,000 + bonus + equity + benefits. Actual pay is determined by multiple factors such as skills, qualifications, experience and market demand.

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

Butterfly Network does not accept agency resumes

Butterfly Network is an E-Verify Company.

Butterfly Network is an equal opportunity employer. Regardless of race, traits associated with 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.

Butterfly requires security adherence responsibilities from all employees. These include: adhering to all company security policies and procedures, utilize provided company assets securely, and complete all required security awareness training programs. Safeguarding company data and systems from unauthorized access, modification, or destruction, contributing to the overall security posture of the organization. Immediately reporting any suspected or actual security incidents, including phishing attempts, malware infections, or unauthorized access, following the established incident response procedures.

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