SaMD Design Quality Engineer (remote position)
Though Elsevier is best known for a storied history in scholarly publishing, we have evolved our business into a decision support and analytics powerhouse that serves the needs of clinicians and scientists. Among our leading products are clinical pathways tools that guide clinicians in the dissemination of evidence based care. These sophisticated software solutions, which aim to "improve every patient outcome," are increasingly likely to be classified as "Software as a Medical Device" (SaMD). Thus, Elsevier is seeking quality and regulatory professionals to join the team.
Job Function:
Serves as quality liaison to design teams to ensure that products are tested against their intended use with consideration of the risk profile; that the testing is documented properly and auditable; and that proper corrective and preventive actions can be undertaken.
Performs design quality engineering tasks related to developing and implementing systems to ensure software products are designed and produced to meet customer and regulatory requirements.
Supports the establishment and implementation of design controls and software development quality processes across multiple products.
Supports new product development and design change activities ensuring execution of the Quality Plan, Product Risk Management activities and other design related activities throughout the product lifecycle.
Works closely with Technology to develop and implement appropriate risk management, qualification, verification, and validation testing plans.
Provides quality engineering support to engineering and regulatory team for technical files, Medical Devices Regulation certification and declarations of conformity in support of EU product registrations/CE mark.
Provides independent oversight and review of the project deliverables throughout the product lifecycle including Feasibility, Development, Design Verification testing, Design Validation testing, Design Transfer, and Commercialization reviews and activities.
Provides quality system guidance and participates where appropriate in Feasibility, Development, Design Verification, Design Validation, Design Transfer and Commercialization reviews and activities from a quality and documentation perspective.
Performs independent technical assessment on product quality performance and post-market product quality analysis.
Participates in quality system audits in accordance with documented procedures.
Interacts with notified bodies and regulatory officials as required during external audits and regulatory reviews.
Skills and Abilities:
Responsible and accountable to the organization for own decisions and actions, while also holding others accountable for the same.
Knowledge and exposure to Medical Device Regulations (FDA 21 CFR Part 820, MDD/MDR, MDSAP etc.) and related ISO/IEC standards (ISO 13485, IEC 62304, ISO 14971, MDDS, TIRs etc.), related to design and development processes.
Ability to work cross functionally to develop and maintain product device files in accordance with quality system requirements and good documentation practices.
Excellent reporting and documentation skills.
Strong project management skills as well as an ability to multitask.
Excellent communication skills, a team player with the ability to connect with business stakeholders.
Be able to apply design control concepts in an Agile Development Environment.
Ability to travel, approximately 10% expected.
V2 Qualifications:
Recent graduates of an engineering or science program (slight preference for Biomedical Engineers) with an interest in on-the-job medical device training are encouraged to apply.
