Sr NPI and Validation Engineer (Onsite - Acton, MA)

Job Summary Position Overview: The Senior Software Validation Quality Engineer is responsible for leading Design Assurance/Quality activities throughout the IT Systems lifecycles and for automated data processing systems used as part of the quality system. Design Assurance/Quality activities include the review of system Requirements, Specs, Designs, Test Protocols and Reports, Validation Plans and Reports, Trace Matrices, and process validations. This includes ensuring that the IT Software Systems and Tools are compliant with applicable standards, regulations and guidance documents for medical devices and GxP computerized systems. This role will interface with other Insulet departments (e.g.IT, Manufacturing, Management, Operations, Research and Development, and Regulatory Affairs). Interactions are required with vendors and other external parties on issues related to IT Systems, Tools, and Product Development, and software used for automation of the quality system. The ability to effectively communicate software and design and development regulatory requirements, optimize the development process, and ensure ambiguities and conflicting requirements are resolved are critical to the success of the position. Responsibilities: • Quality Lead for Design Assurance of IT GxP and non-GxP systems ensuring compliance to applicable regulations including ISO 13485, FDA Quality System Regulation 21 CFR Part 820 and General Principles of Software Validation. • Review requirements, specifications, design documents, validation plans and reports user acceptance protocols, test protocols and reports, traceability matrices and other documentation as required and provide timely feedback. • Familiarity with various software tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.) • Provide expertise in establishing good software requirements, specifications, detailed design, verification and validation protocols and planning documentation • Support efforts for cybersecurity risk management for both US and Rest of World (ROW) requirements. • Support development teams on the validation of software tools. • Applies a good working knowledge of IT Systems Lifecycles, from Requirements through System Retirement, including Risk Management and Change Control. MInimum Requirements: Education and Experience: • BS degree, in an engineering/scientific/computer systems/ or quality management curriculum or equivalent experience. Master’s degree preferred. • Experience with Quality/Design Assurance, and Design Control and Software Development initiatives for FDA Class II and Class III medical devices, mobile applications, cloud-based systems, and cybersecurity. • Familiarity with GAMP 5 guidance. • Experience with a risk-based approach to validate computerized systems, Commercial off the Shelf (COTS) software and SW Tools. • A minimum of 5 years of experience in Software Quality Engineering within an FDA, ISO or other regulated environment. • Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485 quality system standards. • ASQ, CSQE or other software quality certificates are beneficial. Skills/Competencies: • Effective verbal and written communication skills. • Experience collaborating and communicating with individuals at multiple levels in an organization. • Ability to prioritize and manage critical project timelines in a fast-paced environment. Must be able to handle multiple responsibilities concurrently. • Strong analytical and problem-solving skills. • Able to work effectively in a high-stress, high-energy environment. • Ability to manage people and projects in a fast-moving environment. Position Overview: The Senior NPI and Validation Engineer is a critical member of the Global NPI and Validation Engineering team. This role is responsible for transitioning new products into manufacturing (design transfer), providing process validation expertise and support to global manufacturing engineering teams, and providing domestic support for international engineering teams. Regarding design transfer, this role is responsible for providing leadership for the successful introduction of new products, actively engaging with R&D teams to ensure Design for Manufacturing, standardizing design transfer processes, and coordinating Design Transfer activities globally. Regarding process validation support, this role is responsible for standardizing process validation processes, providing formal and informal training to global manufacturing engineering teams, supporting process development and Design of Experiment activities, and driving cost savings projects. Regarding domestic support for international teams, this role is responsible for developing global processes for design transfer and manufacturing, planning engineering builds to support R&D activities, aligning on volume and forecast requirements with supply chain, and supporting the investigation of quality issues. Responsibilities: Ensure the timely and effective launch of new products in the manufacturing space thru early collaboration with systems and R&D teams Provide validation expertise to manufacturing engineers to build departmental capability Drive process improvements in support of Insulet’s primary manufacturing objectives: Best Quality, Best Service, Best Cost Support Global Manufacturing Engineering in all equipment and process validation activities: FAT, SAT, IQ, TMV, and PQ Develop global processes for design transfer and manufacturing Work with supply chain to ensure manufacturing plants can meet volume and forecast requirements Autonomously interpret data to drive cost savings projects Develop and deliver training to build the capability of plant engineering team as part of continuous improvement efforts Ensure compliance with safety rules, quality policies, and employee guidelines Maintain a cGMP compliant environment, operate within FDA guidelines for 21CFR820 manufacturing, and ensure compliance to ISO 13485 Perform other duties as required Education and Experience: B.S. and 5+ years of medical device experience Excellent understanding of structured problem solving tools (e.g. DMAIC, Six Sigma, Black Belt) Expertise in validation of medical device manufacturing processes and equipment Expertise in data analysis tools such as DOE and process development Experience and capability working collaboratively under a Quality Management System (QMS), ISO 13485 preferred The ability to analyze data using various operating systems and programs and to develop intra-department teams to establish goals and take corrective actions to improve performance. undefined Preferred Skills and Competencies: A combination of education, training, and experience that results in demonstrated competency to perform the work may be substituted Hands-on technical ability with assembly methodologies including locational methods, assembly setup, pneumatic actuators, servo motors, limit switches, sensors, robotics, etc. Mechanical aptitude, technical ability, ability to read and understand technical drawings and manuals. Technical knowledge of cam driven linkages, discrete component assembly, and automation Familiarity with machine user interfaces (HMIs / GUIs) Have strong interpersonal and communication skills Excellent attention to detail, organizational skills, and rigorous process discipline Thirst for knowledge and intense curiosity Decision Making – has a systematic and methodical approach to making decisions, seeks out and explores relevant information, thinks creatively beyond the immediate problem, assimilates facts quickly, challenges assumptions, and considers business implications of potential solutions. Communication Skills – Conveys information effectively, actively listens, resolves conflict constructively. Work Organization – Takes a structured, economical approach to resources including time, people, money, and equipment. Problem Solving – Uses a systematic, methodical approach to gather facts, define problems, generate, and implement solutions. Initiative – Makes decisions and takes actions appropriately. Willing to take risks as circumstances require. Planning Skills – Sets goals and priorities, thinks ahead, and identifies activities and resources needed to achieve goals. Perseverance – Achieves objectives by overcoming difficulties through tenacity and resilience. Physical Requirements: Thirst for knowledge and intense curiosity NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite Additional Information: Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $94,600.00 - $141,850.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education. Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com. We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it! At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. (Know Your Rights) Insulet Corporation is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. (Know Your Rights) Insulet employees are all focused on the same goal — to make a difference. Our relentless passion is to simplify life for people with diabetes. We excite and empower employees to bring their best selves to work through a culture that supports a healthy work and life balance. We set the bar high to meet customer needs, and our priority is to ensure our employees are equipped and supported to help us get there. We foster and celebrate curiosity, innovation, and learning. Our teams work collaboratively and are empowered to drive the best actions for our customers. Our innovation spirit and customer-centric focus position us as global pioneers — leading the way to improve health outcomes with revolutionary medical devices while breaking down barriers to access.