Electro-Mechanical Assembler

Help Us Build the Future of the Human Heart.At 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 process you validate, every fixture you design, and every challenge you overcome 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.About The RoleThis is a hands-on technician role, not a production operator position. You’ll work closely with Engineering, Quality, and Operations to assemble, inspect, test, and troubleshoot complex mechanical systems in a highly regulated environment. This role requires someone comfortable working in production, but with an engineering mindset, understanding how and why systems function, not just following steps.Key ResponsibilitiesPerform complex mechanical assembly, repair, inspection, and test operations following detailed work instructionsBuild precision sub-assemblies for the artificial heart pump using small hand tools and measurement equipmentConduct in-process functional checks and mechanical/electrical verificationTroubleshoot assembly and equipment issues, supporting root cause investigations and corrective actionsSupport prototype builds, design verification, and validation activities alongside engineersSet up, calibrate, and maintain assembly and test equipmentComplete accurate production documentation including device history records (DHR) in compliance with GMP/FDA standardsMentor operators and support continuous improvement initiatives within a cleanroom, regulated manufacturing environmentWhat You Bring3–7 years’ experience in mechanical assembly, manufacturing, or production within regulated industries (medical device, aerospace, etc.)Strong hands-on experience building precision mechanical assemblies (not purely testing or inspection roles)Ability to read and interpret engineering drawings and technical documentationExperience troubleshooting mechanical build issues and working closely with engineersComfortable working full-time in a production environment with high quality and documentation standardsStrong attention to detail, manual dexterity, and quality-first mindsetPreferred:Experience in Class III medical devices or other high-reliability productsFamiliarity with FDA QSR (21 CFR Part 820), ISO 13485, and cleanroom environmentsExposure to validation activities (IQ/OQ/PQ) or new product introductionWhat 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 offThe expected salary range for this position based in Huntington Beach California is $28.00 to $34.00. 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.