Sr. Software Quality Engineer

This is a Full-Time, Hybrid position located at our corporate office in Lawrence, MA.

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

· 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.

· Reviews and approves design control deliverables along the product development process as well as design changes

· 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.

· Responsible for the planning and implementation of risk management, the creation and updating of the risk analysis while complying with the relevant standards

· Responsible for the specification of risk reduction measures (requirement management)

· Ensuring that all activities relating to risk management are carried out in accordance with the risk management plan.

· This position is also a cybersecurity and data privacy Subject Matter Expert for global PD products

· Assessing the acceptability of cybersecurity residual risks

· Involvement in the planning of the product roadmap for the implementation of appropriate cybersecurity measures

· Evaluation of events (post-market surveillance) within the scope of complaints/incidents and vulnerability management coordination of product related cybersecurity activities

· Involvement in the definition of policies, SOPs and guidelines for cybersecurity and data privacy

· Compiles, maintains, and evolves approved project deliverables.

· Communicates project and compliance issues to Quality Systems management and provide solutions to potential risks.

· 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.

· Follows all policies, guidelines, and SOPs as required.

· 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.

· Networks with senior internal and external personnel in own area of expertise.

· May escalate issues to supervisor/manager for resolution, as deemed necessary.

· Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.

· Assists with various duties and projects as assigned by a direct supervisor.

· 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

· 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.

· Extended computer-based work in an office environment.

EDUCATION

· Bachelor’s Degree required in Computer Science, Software Engineering, or related field; Advanced Degree desirable.

EXPERIENCE AND REQUIRED SKILLS

· Solid experience in software engineering, information technology, or software quality assurance in a regulated environment; Understanding of Agile methodology desired but not required.

· Thorough understanding of FDA Quality System regulations in relation to software development and validation or strong motivation to learn.

· Extensive experience with one or more of the following highly desirable: SAP, PTC, WindChill, Pilgrim.

· Excellent verbal and written communication skills.

· Excellent team work and interpersonal skills.

· Very strong analytical and problem solving skills.

· Excellent attention to detail, resourceful, self-reliant, self-motivated and confident.