{"id":4243836,"url":"https://alion.io/job/zimmer-biomet-system-engineer","title":"System Engineer","company":{"id":9247,"name":"Zimmer Biomet","domain":"zimmerbiomet.com","url":"https://alion.io/company/zimmer-biomet","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Phenom","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bengaluru, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"ISO 14971","optional":false},{"name":"FMEA","optional":true},{"name":"ISO 13485","optional":true}],"status":"live","first_seen_at":"2026-11-08T00:00:00Z","employer_posted_date":"2026-11-08","last_verified_at":"2026-11-13T12:29:14Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.\nAs a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.\nWhat You Can Expect\nThe Systems Engineer - Complaint & Event Investigation is responsible for conducting rigorous, compliant investigations of product complaints, nonconformances, and adverse events to determine root cause, assess device and patient impact, and support regulatory decision-making. This role plays a critical role in post-market surveillance, MDR assessment, risk management linkage, and inspection readiness.\nThe position partners closely with Quality, Regulatory Affairs, Manufacturing, R&D, and Clinical teams and is especially suited to complex electromechanical or robotic medical devices.\nWork Location: Bangalore\nWork Mode: Hybrid (3 Days in office)\nShift Timing - 11:00 AM - 8:00 PM\nHow You'll Create Impact\nComplaint & Event Investigation\nConduct thorough investigations of complaints, nonconformances, and adverse events\nDetermine root cause, contributing factors, and device performance impact\nEvaluate investigation data including complaint records, service data, manufacturing history, and design documentation\nEnsure investigations are completed accurately, thoroughly, and within required timelines FDA Regulatory Compliance\nPerform investigations in accordance with 21 CFR Part 820 (Quality System Regulation)\nSupport 21 CFR Part 803 (Medical Device Reporting - MDR) reportability assessments\nProvide investigation outputs that support regulatory submissions and health authority inquiries\nEnsure documentation meets FDA and internal quality expectations Risk & Patient Safety Evaluation\nAssess patient safety, clinical risk, and device performance impact of reported events\nLink investigation outcomes to risk management activities per ISO 14971\nSupport updates to risk files, hazard analyses, and risk controls based on post-market findings Cross-Functional Coordination\nCollaborate with Quality, Regulatory Affairs, Manufacturing, R&D, Clinical, and Supplier Quality teams\nFacilitate cross-functional reviews to align on investigation conclusions and next steps\nSupport escalation to CAPA, design changes, process improvements, or MDR reporting as required Documentation & Inspection Readiness\nProduce clear, complete, and traceable investigation records\nEnsure documentation supports FDA inspections, internal audits, and management review\nClearly document conclusions, rationale, and decision-making related to safety and compliance\nWhat Makes You Stand Out\nPreferred Qualifications\n4 to 6 years total experience in regulated medical device environments\nExperience investigating serious injuries, malfunctions, or death-related events\nExperience with robotic, software-driven, or capital medical equipment\nExperience collaborating with Clinical or Medical Affairs teams\nQuality or regulatory certifications (CQE, RAC, Six Sigma - preferred) Core Competencies\nStrong analytical and systems-thinking skills\nHigh attention to detail and documentation rigor\nAbility to make defensible, risk-based decisions\nClear communication with technical, clinical, and regulatory stakeholders\nStrong ownership for patient safety and compliance outcomes\nYour Background\nRequired Technical Skills\nExperience in medical device systems engineering, quality engineering, or post-market surveillance\n3+ years conducting complaint investigations or adverse event investigations in FDA-regulated environments\nDemonstrated experience supporting FDA inspections or regulatory audits\nExperience with complex electromechanical devices; robotic medical device experience preferred Technologies & Tools Quality & Investigation Systems\nElectronic Quality Management Systems (eQMS) (e.g., TrackWise, ETQ, MasterControl)\nComplaint handling and investigation workflows\nNCR, CAPA, and deviation management systems Risk Management & Analysis\nISO 14971 risk management frameworks\nHazard analysis, FMEA/FMECA, fault tree analysis (support level)\nRoot cause analysis tools (5 Whys, Fishbone/Ishikawa) Regulatory & Standards\n21 CFR Part 820 (QSR)\n21 CFR Part 803 (Medical Device Reporting)\nISO 13485 (preferred)\nPost-market surveillance and vigilance processes Data & Documentation\nTechnical documentation systems (PLM, document control systems)\nData analysis tools (Excel - advanced; statistical tools preferred)\nEOE/M/F/Vet/Disability","description_format":"text","description_chars":4996,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Flexible schedule"],"hiring_locations":[{"name":"India","iso":"IN","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Orthopedic & Spine Implants"],"lifecycle":[{"event":"open","at":"2026-11-13T12:18:48Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":5,"expected_fill_days":27,"reasons":["conf:1","win:early","comp:brand"],"computed_at":"2026-11-13T13:43:01Z"},"pay":null,"html_url":"https://alion.io/job/zimmer-biomet-system-engineer","json_url":"https://alion.io/job/zimmer-biomet-system-engineer.json","meta":{"generated_at":"2026-11-13T13:43:01Z","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":27524,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-14T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":9247},"rest":"https://alion.io/mcp/rest/get_company?id=9247"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fzimmer-biomet-system-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"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%2Fzimmer-biomet-system-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Fzimmer-biomet-system-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/zimmer-biomet-system-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fzimmer-biomet-system-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4243836}},{"tool":"search_jobs","arguments":{"company":"zimmerbiomet.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4243836},"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); 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