Senior Manufacturing Engineer, Electrical Systems

About the RoleBiVACOR 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.This 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.Core ResponsibilitiesOwn electrical manufacturing process development and improvement across PCBA, cable/harness, controller, and battery pack assemblyLead process validation (IQ/OQ/PQ/PPQ) and test method validation for electrical manufacturing processes, ensuring compliance with FDA QSR (21 CFR 820) and ISO 13485Investigate and resolve electrical assembly nonconformances (NC/CAPA) using root cause and fault tree methodsAuthor and maintain manufacturing documentation: BOMs, work instructions, solder/crimp specs, test proceduresPartner with Electrical R&D, Quality, and Regulatory as the manufacturing engineering voice on electrical assembliesWhat You Bring — RequiredBS in Electrical Engineering (or closely related field); MS a plus5+ years in electrical manufacturing engineering with PCBA, cable/harness, or electronic sub-assemblyClass III (or active implantable) medical device experience; this is required, not preferredDirect, hands-on ownership of process validation: IQ/OQ/PQ/PPQ, pFMEA, or test method validationWorking knowledge of ISO 13485 and FDA QSRWhat You Bring — Preferred (not required to apply)Familiarity with IPC-610 and IPC-620 or WHMA-A-620 (we'll support depth here on the job)Exposure to supplier qualification/auditing for electronic componentsLean/Six Sigma experienceExperience mentoring junior engineersWhat This Role Grows IntoOver 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.What We OfferBiVACOR offers a competitive compensation package and comprehensive benefits, including:401(k) with company matchingMedical, dental, and vision insuranceHealth Savings Account (HSA) & Flexible Spending Account (FSA)Life insurance & Employee Assistance ProgramGenerous paid time off The 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 postingApply today and be part of something extraordinary.BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.