{"id":744778,"url":"https://alion.io/job/bivacor-manufacturing-engineer-iii","title":"Manufacturing Engineer III","company":{"id":669566,"name":"BiVACOR","domain":"bivacor.com","url":"https://alion.io/company/bivacor","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Ashby","truth_index":{"grade":"B","score":75,"open_postings":8,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-11-09T06:03:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Huntington Beach, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":120000,"max":127000,"currency":"USD","period":"year","gross":null,"usd_annual":127000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"ISO 13485","optional":false},{"name":"21 CFR Part 820","optional":true}],"status":"live","first_seen_at":"2026-06-23T16:07:07Z","employer_posted_date":"2026-06-23","last_verified_at":"2026-11-09T06:07:27Z","board_verified":true,"closed_at":null,"days_open":138,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":138},"description":"Help Us Build the Future of the Human Heart.\n\nAt BiVACOR, we’re developing the world’s most advanced total artificial heart, a technology capable of saving millions of lives around the world. We’re a team united by purpose, working on something truly unprecedented. Every part you track down, every work order you keep moving, and every schedule you protect plays a direct role in giving patients another shot at life. If that’s the kind of work that gets you out of bed in the morning, we think you belong here.\nAbout the Role\nThe Manufacturing Engineer III plays a crucial role in developing, optimizing, and implementing efficient and scalable manufacturing processes for the BiVACOR total artificial heart (TAH). This position focuses on integrating value engineering principles, ensuring high-quality, cost-effective manufacturing while maintaining regulatory and performance standards for implantable components.\nThe Manufacturing Engineer III collaborates with engineering teams, management, and external vendors to improve tooling and component quality, evaluate cost-reduction strategies, and implement process improvements that enhance the long-term viability and manufacturability of the device. The role involves testing, troubleshooting, and optimizing production processes to ensure product conforms to specifications.\nKey Responsibilities\nDesign, develop, and improve manufacturing processes to enhance efficiency and product quality.\n\nImplement Lean and Six Sigma methodologies to reduce waste and optimize workflows.\n\nImplement automation and advanced manufacturing techniques where applicable.\n\nDesign, procure, and validate equipment, tools, and fixtures for manufacturing processes.\n\nEnsure proper calibration and maintenance of manufacturing equipment.\n\nConduct process validations (IQ, OQ, PQ) and ensure compliance with FDA, ISO 13485, and GMP standards.\n\nSupport NC/CAPA investigations and implement corrective actions.\n\nCreate and maintain manufacturing documentation, including BOMs, work instructions, and process flow charts.\n\nPrepare technical reports and documentation for audits and regulatory submissions.\n\nAnalyze and resolve manufacturing issues, including CAPAs and non-conformances.\n\nIdentify opportunities for process improvements and implement solutions to enhance productivity and reduce costs.\n\nWork closely with cross-functional teams, including R&D, Quality Assurance, and Supply Chain, to support product development and manufacturing goals.\n\nProvide technical support to production teams and train operators on new processes and equipment.\n\nWhat You Bring\nBS in Mechanical, Electrical, Biomedical or Manufacturing Engineering, MS desirable (or equivalent)\n\n5+ years engineering experience including skills in process development, Manufacturing Engineering and industrialization preferably in the medical device industry or other highly regulated industry\n\nExpert in process characterization, pFMEAs, MVP, IQ / OQ / PQ / PPQ, and TMVs.\n\nA working knowledge of medical device quality regulations, practices and quality standards, such as ISO 13485 and FDA quality system regulations.\n\nWorking knowledge of industry best practices and applicable standards.\n\nAdvanced problem-solving (Six Sigma Green / Black Belt)\n\nWhat We Offer\nBiVACOR offers a competitive compensation package and comprehensive benefits, including:\n401(k) with company matching\n\nMedical, dental, and vision insurance\n\nHealth Savings Account (HSA) & Flexible Spending Account (FSA)\n\nLife insurance & Employee Assistance Program\n\nGenerous paid time off\n\nThis role is based on-site at BiVACOR’s Huntington Beach headquarters. The expected salary range for this position is $120,000 to $127,000. Actual compensation will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are not available for this posting.\nApply today and be part of something extraordinary.\nBiVACOR is an equal opportunity employer. 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