Medical Device Design Quality Assurance Engineer
Framingham, MA

Job Description

Job Description The Medical Device Design Quality Assurance Engineer (MD-DAE) is responsible for working closely with the Design and Development Teams for medical device hardware and software projects. The MD-DAE will provide guidance to the Design and Development Team to ensure all deliverables satisfy the Medical Development Process (MDP) and applicable regulations and standards. The MD-DAE will also ensure design transfer is accomplished working closely with the MGSC Quality Team. The MD-DAE also provides guidance and support to the MGSC Quality and CED Sustaining Engineering Teams in addressing sustaining quality issues. RESPONSIBILITIES Participate in medical device hardware and software Design and Development Team meetings and activities as a member of the Team. Provide guidance in the interpretation of regulations and standards. Create applicable design and development deliverables associated with the MD-DAE function. Review all Design and Development deliverables ensuring compliance with the MDP and applicable regulations and standards. Provide leadership and understanding for Risk Management activities, ensuring Risk Management Files are kept up to date. Assist product development teams in defining requirements, specification documents and test plans in adherence to applicable standards IEC 62304 Medical Device Software as well as other regulations and guidance as applicable to Cybersecurity and mobile apps. Assist engineering in the compilation of design history files in accordance with ISO 13485, ISO14971 Risk Management and IEC 60601, IEC 62304, or other applicable USFDA and EUMDD regulations Assure all applicable quality decisions utilize risk management documentation as appropriate. Support on-boarding and collaboration with Joint Development Partners (JDM) for quality and regulatory matters. Support JDM supplier evaluation and audit activities. Provide leadership, guidance and approve JDM qualification and validation activities. Support Internal audits of Bose as a qualified auditor/lead auditor. Participate in change assessment activities through to Design Transfer and product launch. Participate in medical device software issue management activities throughout the product lifecycle. Performs other duties as assigned. QUALIFICATIONS BS/BA Degree in a Scientific Discipline or combination of education and relevant work experience. 5 years of Medical Device Design Assurance experience or 2 Years of Medical Device Design Assurance experience supplemented by 3 years of Medical Device Quality Engineering experience. Hands-on experience with medical device software lifecycle processes and change assessments Hands-on experience with medical device software verification and validation activites Experience using Jira or equivalent issue tracking product. Experience with Agile Application Development and Scrum methodologies. Ability to clearly communicate regulatory guidance to development and commercial teams. Key abilities include problem-solving ability, flexibility, and teamwork Exercises good judgement in elevating and communicating actual or potential issues to management. Excellent written and oral communication skills required. Active participation in Agency/Industry groups/forums expected. Knowledge of FDA Quality System Regulation (21 CFR 820), ISO 13485, MDD/MDR. Experience in software development Design Controls regulated under 21 CFR 830 related to Embedded (firmware). Bose is an equal opportunity employer that is committed to inclusion and diversity. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or any other legally protected characteristics. For additional information, please review: (1) the EEO is the Law Poster (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf); and (2) its Supplements (http://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm). Please note, the company's pay transparency is available at http://www.dol.gov/ofccp/pdf/EO13665_PrescribedNondiscriminationPostingLanguage_JRFQA508c.pdf. Bose is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the application or employment process, please send an e-mail to Wellbeing@bose.com and let us know the nature of your request and your contact information.