About Pear Therapeutics:
Pear Therapeutics is the leader in prescription digital therapeutics. We aim to redefine medicine by discovering, developing, and delivering clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has a pipeline of products and product candidates across therapeutic areas, including severe psychiatric and neurological conditions. Our first product, reSET®, treats Substance Use Disorder and was the first prescription digital therapeutic to receive marketing authorization from the FDA to treat disease. Pear’s second product, reSET-O™, for the treatment of Opioid Use Disorder, received marketing clearance from the FDA in December 2018. Pear’s third PDT, SomrystTM, is the first FDA-authorized prescription digital therapeutic (PDT) for patients with chronic insomnia and the first product submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed through FDA’s Software Precertification Pilot Program.
About the Team
Our Quality team is an exciting, fast-paced group of medical device and software experts who implement Quality and Regulatory strategies in a software development organization. We treat each other well, believe in building a diverse culture of collaboration, and are serious about making Pear a place that’s good for both those who work here and the patients we serve.
The Design Assurance Engineer reports to the Director of Quality Operations within the Clinical, Regulatory, Quality and Medical (CRQM) Organization.
About the Role:
In this role, you will serve as a design assurance engineer for Pear product to actively manage design controls and design history file (DHF) development for software products, including software as a medical device (SaMD). You will be expected to apply your knowledge of medical device product development in a regulated environment creating health-related software products for digital applications.
- Proficiency in medical device Quality Management System regulations and standards including ISO 13485 and 21 CFR 820, with a focus on 21 CFR 820.30 Design Controls
- Thorough knowledge and understanding of EN ISO 14971 and other risk management practices
- Familiarity with software development, including Agile methodologies
- Strong interpersonal, communication (verbal and written), organizational and project management skills
- Ability to motivate and influence people to achieve compliance to requirements
- Self-motivated but committed to a team oriented approach
- Candidate must be able to think in an Agile framework and know how to extract useful design outputs/ artifacts in collaboration with software development engineers. It is critical to understand how design controls can be implemented at a software company.
- Represent the Quality and Design Assurance function in software development core teams and other cross-functional teams
- Own Design History Files (DHF) and related records for software development projects for medical device software products (SaMD) for legacy and new products
- In conjunction with the technical team, develop and provide feedback on design documentation including user needs, software requirements specifications, design specifications, and verification/ validation plans and reports.
- Lead and perform risk management activities for software products
- Assure design reviews are compliant to standards and procedures
- Lead design change assessment and configuration management with Product teams
- Support updates to QMS documentation and other QMS areas including NC, CAPA, complaints, management reviews and others, as needed