{"id":1273829,"url":"https://alion.io/job/insulet-quality-engineer-npi-programs","title":"Quality Engineer - NPI Programs","company":{"id":5958,"name":"Insulet","domain":"insulet.com","url":"https://alion.io/company/insulet","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":92,"open_postings":20,"ghost_share":0,"stale_share":0.3,"repost_share":0.05,"time_to_fill_p50_days":26,"computed_at":"2026-09-30T05:45:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Acton, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":70400,"max":105650,"currency":"USD","period":"year","gross":null,"usd_annual":105650},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-09-25T00:00:00Z","employer_posted_date":"2026-09-25","last_verified_at":"2026-09-30T10:42:29Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"Job Summary\nThe Quality Engineer, NGP Programs is responsible for supporting quality engineering activities to facilitate early-stage product development and pilot manufacturing operations.This role operates at the intersection of Quality, R&D and Manufacturing, ensuring prototype and pilot builds are well-controlled and enable successful progression to clinical builds and eventual commercial scale. The individual will establish and execute quality strategies for pilot line operations, including inspection plans, risk management, and design transfer to manufacturing.\nWorking closely with R&D, Manufacturing Engineering, and Clinical/Regulatory teams, this role ensures that builds are executed to internal processes and feasibility procedures and other GMP/ISO standards, as necessary then transitioning o Insulet’s Quality Management Systemwhile building the foundation for scalable, production-ready quality manufacturing processes.\nA critical responsibility is ensuring product quality readiness for internal feasibility, clinical and commercialization milestones-driving disciplined execution in pilot manufacturing while enabling an efficient, compliant design transfer to manufacturing.\n\nPosition Overview\nThe Quality Engineer, NPI Programs plays a critical role in supporting new product development and pilot manufacturing by ensuring quality is built into products and processes from the earliest stages of development through commercialization.\nOperating at the intersection of R&D, Manufacturing, and Quality, this individual will lead quality engineering activities for prototype, pilot, clinical, and pre-commercial manufacturing builds. The role is responsible for establishing and maintaining quality systems, inspection strategies, risk management processes, and design control compliance that enable efficient product development while creating a scalable foundation for commercial manufacturing.\nWorking closely with cross-functional teams, including R&D, Manufacturing Engineering, Operations, Clinical, and Regulatory Affairs, the Quality Engineer ensures product and process readiness, regulatory compliance, and successful transfer from development into production.\nResponsibilities\nLead quality engineering activities supporting prototype, pilot, clinical, and development manufacturing builds.\nDevelop and maintain inspection plans, control plans, procedures, work instructions, and quality standards for evolving products and manufacturing processes.\nDefine and implement inspection and test methodologies to support product development, pilot manufacturing, and release activities.\nEnsure compliance with design controls, traceability requirements, quality systems, and product documentation throughout the development lifecycle.\nSupport Design History File (DHF) and Device History Record (DHR) compliance, lot release activities, and clinical build readiness.\nAnalyze quality and manufacturing data to identify trends, mitigate risks, and drive continuous improvement initiatives.\nLead investigations of nonconforming materials and products, conducting root cause analysis and implementing corrective and preventive actions (CAPA).\nFacilitate risk management activities, including DFMEA, PFMEA, and development of process control strategies.\nSupport qualification and validation of manufacturing equipment, inspection systems, test methods, and production processes (IQ/OQ/PQ).\nPartner with R&D and Manufacturing Engineering teams to improve product manufacturability, inspectability, reliability, and process capability.\nSupport manufacturing transfer and commercialization efforts through development of production quality controls and readiness assessments.\nEnsure compliance with FDA Quality System Regulations, ISO 13485, GMP requirements, and applicable regulatory standards.\nKey Decision-Making Responsibilities\nRecommend inspection methods, sampling plans, acceptance criteria, and quality controls for development and pilot manufacturing operations.\nEvaluate nonconforming materials and products, providing disposition recommendations and corrective actions.\nIdentify, assess, and escalate product, process, and quality risks that may impact development timelines or commercialization readiness.\nProvide quality engineering expertise during design reviews, risk assessments, validation activities, and manufacturing readiness reviews.\nLeadership & Interpersonal Competencies\nStrong technical problem-solving, troubleshooting, and analytical skills.\nAbility to effectively collaborate and influence cross-functional teams across R&D, Manufacturing, Operations, and Quality.\nComfortable operating in a fast-paced, dynamic product development environment.\nDemonstrated ability to manage multiple priorities and deliver results on schedule.\nExcellent written, verbal, and presentation communication skills.\nHighly detail-oriented with a data-driven approach to decision-making and continuous improvement.\nAbility to influence technical decisions through sound engineering judgment and quality expertise.\nBasic Requirements\nBachelor's degree in engineering or a related technical discipline.\nAt least 3 years of Quality Engineering experience in a regulated industry.\nExperience with inspection methods, metrology systems, test methods, and measurement system analysis.\nKnowledge of FDA QSR (21 CFR 820) and ISO 13485 quality system requirements.\nUnderstanding of design controls, risk management, and medical device quality systems.\nFamiliarity with Design History File (DHF) and Device History Record (DHR) requirements.\nExperience supporting manufacturing operations, process development, pilot manufacturing, or New Product Introduction (NPI) programs.\nExperience with equipment and process validation activities (IQ/OQ/PQ).\nKnowledge of quality engineering tools, including root cause analysis, statistical analysis, and process capability studies.\nStrong analytical, problem-solving, and cross-functional collaboration skills.\nPreferred Qualifications\nMedical device industry experience.\nExperience supporting new product development (NPD) programs.\nExperience with design controls, risk management, and manufacturing quality initiatives.\nDemonstrated ability to drive quality improvements in a cross-functional environment.\nAdditional Information:\n\nCompensation & Benefits:\n\nFor U.S.-based positions only, the annual base salary range for this role is $70,400.00 - $105,650.00\n\nThis position may also be eligible for incentive compensation.\n\nWe offer a comprehensive benefits package, including:\n• Medical, dental, and vision insurance\n• 401(k) with company match\n• Paid time off (PTO)\n• And additional employee wellness programs\n\nApplication Details:\nThis job posting will remain open until the position is filled.\nTo apply, please visit the Insulet Careers site and submit your application online.\n\nActual 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.\nWe 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!\nAt 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.\n(Know Your Rights)","description_format":"text","description_chars":8432,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Vision insurance","Wellness"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Diabetes Devices"],"lifecycle":[{"event":"open","at":"2026-09-26T00:49:49Z"}],"liveness":{"score":88,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.877,"p_room":1,"age_days":5,"expected_fill_days":26,"reasons":["conf:4","velocity","win:early","comp:brand"],"computed_at":"2026-09-30T05:45:00Z"},"pay":{"stated_usd_annual":105650,"is_top_pay":false},"html_url":"https://alion.io/job/insulet-quality-engineer-npi-programs","json_url":"https://alion.io/job/insulet-quality-engineer-npi-programs.json","meta":{"generated_at":"2026-10-01T03:38:15Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":3194,"day_limit":5000,"remaining_today":1806,"minute_limit":60,"resets_at":"2026-10-02T00:00:00Z"}}}