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 lead 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.

About the Team

Our Quality team (QA) is an exciting, fast-paced group of medical device, software, and pharma 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 Associate Director of Quality Operations within the Clinical, Regulatory, Quality (CRQ) 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.

Required Qualifications:

• • Expertise 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 is implemented in an Agile company.

Responsibilities:

• • Represent the Quality function in all software development core teams and other cross-functional teams
  • Own Design History Files for (DHF) for software development projects for medical device software products (SaMD) for legacy and new products
  • In conjunction with the technical team, develop and organize design documentation including user needs, software requirements specifications, design specifications, verification/ validation plans and protocols, and risk management
  • 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

Preferred Qualifications:

• • Familiarity with Agile-based development methodologies desirable (ex: AAMI TIR 45)
  • Expertise in IEC 62304 or other software development methodologies desirable

Education:

• • Bachelor’s degree or equivalent experience (engineering or technical discipline degree desirable)
  • 5+ years’ experience in a quality role (quality engineer, design quality engineer)
  • 3+ years working with software devices and products
  • Demonstrated involvement in medical device quality systems management
  • Combination product and software development work experience desirable

Equal Employment Opportunity:

Pear Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion or religious creed, ancestry, age, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), sexual orientation, gender identity or gender expression, national origin, genetic information, qualified physical or mental disability or handicap, medical condition, qualified military or veteran status, or any other basis protected by applicable law. Pear Therapeutics also follows all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. This policy applies to all terms and conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfers, leave of absences, compensation and training.

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