{"id":3423100,"url":"https://alion.io/job/insulet-staff-npi-engineer","title":"Staff NPI Engineer","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":93,"open_postings":26,"ghost_share":0,"stale_share":0.231,"repost_share":0.077,"time_to_fill_p50_days":30,"computed_at":"2026-10-30T05:48:23Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"staff","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Gelang Patah, Malaysia"],"countries":["MY"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":21000,"max_usd":49000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":1702},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"FMEA","optional":false},{"name":"GMP","optional":false},{"name":"ISO 13485","optional":false}],"status":"live","first_seen_at":"2026-10-28T21:28:55Z","employer_posted_date":"2026-10-28","last_verified_at":"2026-10-30T09:36:04Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Job Summary\nPosition Overview:The NPI Staff Engineer is a critical member of the NPI Engineering team and will play a key role in the successful start-up and ongoing operation of Insulet Malaysia Sdn. Bhd.'s manufacturing facility in Johor Bahru. The individual will support the introduction of new products, Design and process transfers, engineering builds, equipment qualifications, process validations, and continuous improvement initiatives to ensure successful manufacturing readiness and sustained operational performance.\nThis role is responsible for planning, coordinating, including Engineering Builds, Design Verification Builds, and other product and process validation activities. The engineer will work closely with cross-functional teams including Operations, Manufacturing Engineering, Quality, R&D, Supply Chain, and external suppliers to ensure projects are delivered safely, efficiently, and in compliance with applicable quality and regulatory requirements.\nThe successful candidate will apply structured problem-solving methods, engineering principles, and project management skills to drive quality, efficiency, and cost improvements while supporting manufacturing ramp-up and operational excellence\nInsulet Corporation (NASDAQ: PODD) is an innovative medical device company dedicated to making the lives of people with diabetes easier. Through its OmniPod Insulin Management System, Insulet seeks to expand the use of insulin pump therapy among people with insulin-dependent diabetes. Insulet's Delivery Systems business also partners with global pharmaceutical and biotechnology companies to tailor the OmniPod technology platform for the delivery of subcutaneous drugs across multiple therapeutic areas.\n\nPosition Overview:\nThe NPI Staff Engineer is a critical member of the NPI Engineering team and will play a key role in the successful start-up and ongoing operation of Insulet Malaysia Sdn. Bhd.'s manufacturing facility in Johor Bahru. The individual will support the introduction of new products, Design and process transfers, engineering builds, equipment qualifications, process validations, and continuous improvement initiatives to ensure successful manufacturing readiness and sustained operational performance.\nThis role is responsible for planning, coordinating, including Engineering Builds, Design Verification Builds, and other product and process validation activities. The engineer will work closely with cross-functional teams including Operations, Manufacturing Engineering, Quality, R&D, Supply Chain, and external suppliers to ensure projects are delivered safely, efficiently, and in compliance with applicable quality and regulatory requirements.\nThe successful candidate will apply structured problem-solving methods, engineering principles, and project management skills to drive quality, efficiency, and cost improvements while supporting manufacturing ramp-up and operational excellence\nInsulet Corporation (NASDAQ: PODD) is an innovative medical device company dedicated to making the lives of people with diabetes easier. Through its OmniPod Insulin Management System, Insulet seeks to expand the use of insulin pump therapy among people with insulin-dependent diabetes. Insulet's Delivery Systems business also partners with global pharmaceutical and biotechnology companies to tailor the OmniPod technology platform for the delivery of subcutaneous drugs across multiple therapeutic areas.\nResponsibilities:\nReport to the Senior Manager, NPI & Test Engineering and provide technical leadership, coaching, and mentoring to engineers and technicians.\nLead and support New Product Introduction (NPI) programs, product transfers, and assigned engineering projects throughout the project lifecycle, including concept development, planning, qualification, validation, implementation, manufacturing readiness, production ramp-up, and sustaining support\nLead equipment qualification and process validation activities, including IQ/OQ/PQ execution and documentation.\nCollaborate cross-functionally with Operations, Quality, Manufacturing Engineering, R&D, Supply Chain, and external partners to support project execution and manufacturing objectives.\nLead continuous improvement initiatives by utilizing structured problem-solving methodologies to investigate product, process, equipment, and manufacturing issues and implement effective corrective and preventive actions (CAPA) to improve quality, yield, equipment performance, and operational efficiency.\nLead risk identification, assessment, and mitigation activities throughout NPI, validation, and production transfer projects using PFMEA, risk assessments, and structured risk management methodologies.\nMaintain a cGMP-compliant environment and ensure compliance with FDA, ISO 13485, and company Quality System requirements.\nMonitor project, quality, and operational metrics and drive actions required to achieve established performance targets.\nAuthor and review engineering documentation including validation protocols, reports, investigations, work instructions, SOPs, engineering assessments, and risk management documentation.\nPerform other duties as assigned.\nMinimum Requirements:\nEducation and Experience:\n B.S. and 8+ years of medical device experience, preference in Mechanical, Electrical, or Industrial engineering\nStrong project management skills with experience leading cross-functional NPI, technology transfer, equipment qualification, and process validation projects, including planning, execution, risk management, and delivery of results within established timelines\nExperience with IQ/OQ/PQ execution and validation documentation.\nKnowledge of FDA 21 CFR Part 820, ISO 13485, cGMP, and risk management methodologies including PFMEA.\nExcellent understanding of structured problem-solving tools (e.g. DMAIC, Six Sigma Green Belt)\nMulti-language fluency (English and Mandarin minimum)\nWork experience at high-volume manufacturing line in cleanroom environmentundefinedundefined\nPreferred Skills and Competencies:\nFamiliarity with cGMP, ISO 13485, and FDA 21 CFR Part 820 requirements.\nAbility to perform effectively in a fast-paced, high-volume manufacturing environment.\nStrong decision-making skills with the ability to evaluate risks, analyze information, and implement practical solutions.\nExcellent communication and interpersonal skills with the ability to collaborate effectively across cross-functional teams.\nStrong structured problem-solving skills and the ability to drive issues to resolution.\nDemonstrated initiative, accountability, and ownership in achieving project and business objectives.\nStrong planning, prioritization, and organizational skills with the ability to manage multiple tasks and competing priorities.\nPhysical Requirements (if applicable):\nAble to work off shifts (nights/weekends) as needed, 10% max\nNOTE: This position requires on-site working (requires on-site office/plant/lab work)\nInsulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.\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!","description_format":"text","description_chars":7526,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Diabetes Devices"],"lifecycle":[{"event":"open","at":"2026-10-28T21:28:55Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":1,"expected_fill_days":30,"reasons":["conf:1","velocity","win:early","comp:brand"],"computed_at":"2026-10-30T05:48:23Z"},"pay":null,"html_url":"https://alion.io/job/insulet-staff-npi-engineer","json_url":"https://alion.io/job/insulet-staff-npi-engineer.json","meta":{"generated_at":"2026-10-30T21:54:23Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":12446,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-31T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":5958},"rest":"https://alion.io/mcp/rest/get_company?id=5958"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Finsulet-staff-npi-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Finsulet-staff-npi-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Finsulet-staff-npi-engineer"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/insulet-staff-npi-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Finsulet-staff-npi-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3423100}},{"tool":"search_jobs","arguments":{"company":"insulet.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3423100},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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