Principal Engineer - Digital Health Quality

Primarily responsible for representing QA on cross-functional Software as a medical device (SaMD) product development teams and executing Quality System requirements to ensure products are developed, tested, and released in compliance with worldwide Medical Device Regulations. Responsible for authoring, reviewing, and approving project documentation associated with the SDLC and design control requirements to support Corporate, Division, FDA, and other regulatory requirements. In addition to these primary areas of focus, quality assurance will also be responsible for creating and maintaining QMS documents for the development of SaMD’s in compliance with IEC 62304, 21 CFR 820.30, EU MDR and other applicable regulations.

•Perform QA activities related to Software as a Medical Device (SaMD) Development.
•Ensure compliance with AbbVie’s software lifecycle policies and procedures. Perform design control and risk management activities according to AbbVie's Quality System and applicable standards.
•Mentor/lead product team members through the design process providing guidance to assure optimal approach. Work closely with technical team to ensure potential product issues are identified and addressed in the design.  Assure robust product vs. customer requirements.
•Ensure design control documentation (Traceability/Linkages) & design change control requirements are met. Assess the impact of a change on the safety, efficacy of the software medical device. Analyze and justify the impact on cumulative changes.
•Support the creation of regulatory submission documentation.
•Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.
•Initiate assignments independently.  Actively lead and participate on development and process improvement teams.  Anticipate/resolve quality issues and take preventative actions. Lead cross-functional teams for solution development and implementation
•Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements.
•Write/review policies/processes/procedures and related documents for the development of SaMD’s in compliance with IEC 62304, 21 CFR 820.30, EU MDR and other applicable regulation.
•Guide project development as team member in global and local product development teams to proactively and appropriately address quality-related issues. Advise internal business partners with regard to software medical device product regulations.

•Bachelor's degree is required; preferably in sciences, engineering or other technical/scientific area.
•Minimum 7 years of industry experience in Quality Assurance, Development or healthcare related field. Medical device experience required. Less experience considered with advanced degree.
•Strong understanding of regulations and standards affecting SaMD such as IEC 62304, 21 CFR 820.30 and EU MDR.
•Experience with creation and maintenance of QMS documents for development of medical devices.
•Experience in coordination and planning of complex activities and ability to identify and resolve complex problems through effective use of technical and interpersonal skills.
•Product development experience (e.g. approaches for definition of requirements and specification setting for verification and validation).   Practical experience in design control and risk management.
•Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues.
•Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities.
•Able to take the initiative to identify and implement new approaches to resolve problems, able to challenge scientific arguments - strong analytical approach to identify problem areas and effective solutions.
•Work independently and in a global team environment, and with all levels of personnel within the organization.

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.