{"id":744776,"url":"https://alion.io/job/bivacor-senior-manufacturing-engineer-electrical-systems","title":"Senior Manufacturing Engineer, Electrical Systems","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":"2026-11-11T05:49:22Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","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":155000,"currency":"USD","period":"year","gross":null,"usd_annual":155000},"salary_estimate":null,"experience_years_min":5,"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":"ISO 13485","optional":false}],"status":"live","first_seen_at":"2026-09-10T16:16:14Z","employer_posted_date":"2026-09-10","last_verified_at":"2026-11-11T08:58:44Z","board_verified":true,"closed_at":null,"days_open":61,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":61},"description":"About the Role\nBiVACOR is building the world's first Total Artificial Heart a Class III, FDA-regulated active implantable device. We're looking for a Senior Manufacturing Engineer who combines strong electrical engineering fundamentals with hands-on process validation ownership, to help take our electrical manufacturing (PCBA, cable/harness, controller assembly, battery systems) from development into validated, compliant production.\nThis is a technical ownership role, not a generalist one: we need someone who can look at a board, harness, or controller assembly and understand it at the electrical level, and who can build and defend the validation package (IQ/OQ/PQ/PPQ) that proves it's manufacturable and compliant.\nCore Responsibilities\nOwn electrical manufacturing process development and improvement across PCBA, cable/harness, controller, and battery pack assembly\n\nLead process validation (IQ/OQ/PQ/PPQ) and test method validation for electrical manufacturing processes, ensuring compliance with FDA QSR (21 CFR 820) and ISO 13485\n\nInvestigate and resolve electrical assembly nonconformances (NC/CAPA) using root cause and fault tree methods\n\nAuthor and maintain manufacturing documentation: BOMs, work instructions, solder/crimp specs, test procedures\n\nPartner with Electrical R&D, Quality, and Regulatory as the manufacturing engineering voice on electrical assemblies\n\nWhat You Bring - Required\nBS in Electrical Engineering (or closely related field); MS a plus\n\n5+ years in electrical manufacturing engineering with PCBA, cable/harness, or electronic sub-assembly\n\nClass III (or active implantable) medical device experience; this is required, not preferred\n\nDirect, hands-on ownership of process validation: IQ/OQ/PQ/PPQ, pFMEA, or test method validation\n\nWorking knowledge of ISO 13485 and FDA QSR\n\nWhat You Bring - Preferred (not required to apply)\nFamiliarity with IPC-610 and IPC-620 or WHMA-A-620 (we'll support depth here on the job)\n\nExposure to supplier qualification/auditing for electronic components\n\nLean/Six Sigma experience\n\nExperience mentoring junior engineers\n\nWhat This Role Grows Into\nOver time, this role has a path toward broader ownership of supplier quality, cross-team process leadership, and mentoring junior manufacturing engineers as the team scales but you won't be expected to own all of that from day one.\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\nThe expected salary range for this position based in Huntington Beach California is $120,000 - $155,000. Actual pay 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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