Quality Engineer Jobs

Description

The Company

Better Therapeutics is a prescription digital therapeutics (PDT) company developing a novel form of cognitive behavioral therapy to address the root causes of cardiometabolic diseases and has developed a proprietary platform for the development of FDA-regulated, software-based solutions. In July 2023, the company received FDA authorization for its first asset, AspyreRx™. Scheduled to launch commercially in Q4, 2023, AspyreRx™ is a PDT indicated to treat adults with Type 2 Diabetes (T2D) and is backed by robust data demonstrating clinically meaningful and statistically significant durable reduction in A1c.

The cognitive behavioral therapy delivered by Better Therapeutics’ PDT is designed to enable changes in neural pathways of the brain so lasting changes in behavior become possible. Addressing the underlying causes of these diseases has the potential to dramatically improve patient health while lowering healthcare costs. Better Therapeutics’ clinically validated mobile application must be prescribed by physicians and reimbursed like traditional medicines.

Better Therapeutics operates as a fully distributed company combining remote work with periodic team and company wide in-person meetings. We have employees located in 15 states across the country.

The Role

The Quality Engineer is a newly created position that plays a key role in the successful development and deployment of our DTx software applications. The QE is responsible for overseeing quality system processes related to ongoing software development and post-market surveillance, including change control and incident management, and working cross-functionally to help resolve reported issues and provide accurate feedback to the product development teams.

The QE will work cross-functionally with the product development, support, and clinical teams to help deploy critical quality processes focused on technical product development. This includes helping to ensure that customer complaints are followed-up, software problems and CAPA’s are resolved, and software changes are thoroughly analyzed.

To be successful in this role, the candidate will have a deep knowledge of FDA medical device quality system regulations, good technical aptitude, be a self-starter and comfortable working within new software systems. The QE will provide knowledge and guidance on best software development practices so that teams can successfully navigate through highly fluid and Agile processes.

Requirements

In this role, you will:

• Lead the the complaint investigation processes, failure and root cause analyses, and provide closed-loop feedback to the Product Development and Engineering Teams
• Oversee and monitor the CAPA process and ensure closed loop-feedback and resolution as it applies to both products and QMS processes
• Oversee the product development change control process so that implementation of software improvements and new features is complete, compliant, and documented according to our QMS
• Support the Product Development Team in the creation, investigation, resolution, and other details related to quality incidents within the QMS software
• Partner with the Product Quality, the Product Development Team, Engineering, Product Support, Patient Services and others ensure that our software products are developed and sustained in an efficient and compliant manner
• Trend and report complaint and CAPA metrics on a monthly basis to ensure sufficient management oversight; support the Management Review process with data-based performance analysis for complaints and CAPAs
• Oversee the Medical Device Reporting (MDR) decision-making process to ensure timely reporting and resolution of MDRs in compliance with FDA requirements

What You Bring

• Excellent verbal and written communication and collaboration skills with proficiency in technical writing
• Ability to adapt to the changing and fast-paced environment of Agile software development
• 5+ years experience working under medical device quality systems
• Ability to understand and clearly articulate FDA Quality System Requirements and guidance related to medical device and software development
• 2+ years working with SaMD or other medical software preferred
• Bachelor's degree
• Digital therapeutics and startup experience is a big plus
• Competency working with software systems and an ability to learn, configure, and troubleshoot with little guidance

Who You Are

• You are a critical thinker, but not critical of others
• You are driven by a sense of purpose, and possess a confidence, competence, and willingness to be accountable
• You have the intellect to grasp complex ideas, a thirst for learning, and the creative approach to problem solving
• You are not intimidated by the fast-paced, dynamic characteristics of startups
• You are comfortable working in a fully remote setting
• You give credit and take responsibility, always defaulting to “we” over “me”
• You know what a growth mindset is, and it embodies the way you live your life
• You are fascinated by technology and the way it transforms the way people live and work
• You are always up for a new challenge, not afraid to fail, and insatiably curious

Benefits

What we offer

We Also Offer

We will provide the opportunity to do purposeful work in an ego-free and collaborative team environment. Our culture is infused with passion and purpose, where curiosity is encouraged, conversation is lively, and differing opinions are treated with respect. We expect you to make a significant impact.

• Flexible vacation and parental leave
• Competitive salary, bonus, and equity compensation
• Health, dental, and vision benefits
• Participation in employee stock purchase plans
• Health, wellness, and work-from-home allowance
• 401k retirement savings plan

We carefully hire the best talent we can find, which means actively seeking diversity of backgrounds, education, and ways of thinking. We strive to build an inclusive culture where differences are celebrated and leveraged to inform better design and business decisions. Better is proud to be an equal opportunity workplace and affirmative action employer. We are committed to equal opportunity regardless of race, color, religion, sex, gender identity, national origin, ancestry, citizenship, age, physical or mental disability, legally protected medical condition, family care status, military or veteran status, marital status, domestic partner status, sexual orientation, or any other basis protected by local, state, or federal laws.

Pay Transparency

At Better Therapeutics, the base salary is one part of our total compensation offering. The annual salary range for this position at commencement of employment is estimated to be between $140,000 and $190,000. Further, final pay determinations will depend on various factors, including, but not limited to, experience level, skills, knowledge, and professional qualifications. Our total compensation offering for this position may include other elements, including equity-based awards, benefits, developmental opportunities and being part of a mission driven culture. Employees are covered by medical, dental, vision, and basic life insurance. Employees are able to enroll in our Company’s 401k plan, as well as a deferred compensation plan, and flexible paid time off will be available in accordance with the Company’s leave policy. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time for any lawful reason, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Vaccination Policy

As part of Better Therapeutics' continued commitment to maintaining a safe and healthy workplace, we encourage employees to be fully vaccinated against COVID-19. This measure is intended to protect you, your coworkers, your families, and our customers from contracting and spreading COVID-19.

Better Therapeutics will comply with customer requirements regarding vaccinations for on-site visitors. Therefore, in certain customer-facing roles that require on-site visits to health systems, hospitals, clinics, and/or physician offices, etc. as part of the essential job functions, proof of current COVID-19 vaccination status may be required. Please contact our Manager of People Operations, Irina Zakharchenko, at [email protected], for information about reasonable accommodations and exemption requests.

Information Security, Privacy & Compliance Policy

As an employee of Better Therapeutics, you may have access to Protected Health Information (PHI) or other information regulated by state and federal law. You will be required to complete all company assigned training within the allotted time and adhere to all company policies, standards and guidelines.

Apply to join our team

Qualified candidates, please apply on our careers page.