Sr. Software Quality Engineer

PURPOSE AND SCOPE Act as a Quality Business Partner for Software as a Medical Device and Non-medical software device engineering teams to ensure compliant products, engineering teams are supported with a value-added mindset, and Post Market Surveillance activities are performed, and actions derived PRINCIPAL DUTIES AND RESPONSIBILITIES u00b7 Works as part of software development team on new product development or on design changes to ensure product quality and minimize risk to users and patients as well as regulatory and corporate SOP compliance. u00b7 Reviews and approves design control deliverables along the product development process as well as design changes u00b7 Partners with and/or guide software project teams to ensure that software systems are compliant with procedures and Regulations such as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. u00b7 Responsible for the planning and implementation of risk management, the creation and updating of the risk analysis while complying with the relevant standards u00b7 Responsible for the specification of risk reduction measures (requirement management) u00b7 Ensuring that all activities relating to risk management are carried out in accordance with the risk management plan. u00b7 This position is also a cybersecurity and data privacy Subject Matter Expert for global PD products u00b7 Assessing the acceptability of cybersecurity residual risks u00b7 Involvement in the planning of the product roadmap for the implementation of appropriate cybersecurity measures u00b7 Evaluation of events (post-market surveillance) within the scope of complaints/incidents and vulnerability management coordination of product related cybersecurity activities u00b7 Involvement in the definition of policies, SOPs and guidelines for cybersecurity and data privacy u00b7 Compiles, maintains, and evolves approved project deliverables. u00b7 Communicates project and compliance issues to Quality Systems management and provide solutions to potential risks. u00b7 Develops and project manages internal and external regulatory audits/inspections by presenting and defending software projects and documentation during audits and inspections as the Subject Matter Expert. u00b7 Follows all policies, guidelines, and SOPs as required. u00b7 Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. u00b7 Networks with senior internal and external personnel in own area of expertise. u00b7 May escalate issues to supervisor/manager for resolution, as deemed necessary. u00b7 Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations. u00b7 Assists with various duties and projects as assigned by a direct supervisor. u00b7 Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions. PHYSICAL DEMANDS AND WORKING CONDITIONS u00b7 The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. u00b7 Extended computer-based work in an office environment. EDUCATION u00b7 Bacheloru2019s Degree required in Computer Science, Software Engineering, or related field; Advanced Degree desirable. EXPERIENCE AND REQUIRED SKILLS u00b7 Solid experience in software engineering, information technology, or software quality assurance in a regulated environment; Understanding of Agile methodology desired but not required. u00b7 Thorough understanding of FDA Quality System regulations in relation to software development and validation or strong motivation to learn. u00b7 Extensive experience with one or more of the following highly desirable: SAP, PTC, WindChill, Pilgrim. u00b7 Excellent verbal and written communication skills. u00b7 Excellent team work and interpersonal skills. u00b7 Very strong analytical and problem solving skills. u00b7 Excellent attention to detail, resourceful, self-reliant, self-motivated and confident. The rate of pay for this position will depend on the successful candidateu2019s work location and qualifications, including relevant education, work experience, skills, and competencies. Annual Rate: $120,000 - $140,000 for Lawrence, MA location. Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave. EOE, disability/veterans

Created: 2025-12-05