{"id":744779,"url":"https://alion.io/job/bivacor-principal-manufacturing-mechanical-engineer","title":"Principal Manufacturing Mechanical Engineer","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":"2026-11-12T10:38:37Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","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":130000,"max":153000,"currency":"USD","period":"year","gross":null,"usd_annual":153000},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design History File","optional":false},{"name":"GMP","optional":false},{"name":"ISO 13485","optional":false},{"name":"21 CFR Part 820","optional":true}],"status":"live","first_seen_at":"2026-06-23T15:59:51Z","employer_posted_date":"2026-06-23","last_verified_at":"2026-11-12T12:05:30Z","board_verified":true,"closed_at":null,"days_open":141,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":141},"description":"Help Us Build the Future of the Human Heart.\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 process you optimize, every validation you lead, and every engineer you mentor 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 Principal Manufacturing Engineer leads cross-functional collaboration with R&D, Quality, and Supply Chain teams, as well as external partners, to elevate tooling and component quality and deliver sustained cost reduction. Beyond hands-on process ownership, this role carries significant technical leadership responsibilities, mentoring junior engineers, leading high-impact improvement initiatives, and contributing to the manufacturing strategy that supports the long-term commercialization of our device.\nKey Responsibilities\nChampion Lean and Six Sigma methodologies, driving measurable waste reduction and a culture of continuous improvement across manufacturing\n\nEvaluate and implement automation and advanced manufacturing techniques to improve throughput, repeatability, and cost-effectiveness at scale\n\nLead the design, procurement, and validation of equipment, tools, and fixtures to meet technical, regulatory, and production requirements\n\nOwn process validation execution (IQ, OQ, PQ, PPQ), ensuring full compliance with FDA, ISO 13485, and GMP standards\n\nLead NC/CAPA investigations and root cause analysis, implementing corrective and preventive actions that resolve systemic issues and prevent recurrence\n\nManage complex, cross-functional manufacturing engineering projects from initiation through completion, ensuring on-time, on-budget delivery aligned with business objectives\n\nDefine and enforce manufacturing engineering standards and design-for-manufacturability (DFM) guidelines across the product development lifecycle\n\nShape manufacturing strategy and roadmap development, providing technical input on scale-up, technology transfer, and commercialization\n\nServe as the senior manufacturing engineering voice in cross-functional collaboration with R&D, Quality, Supply Chain, and Regulatory teams during product development and design transfer\n\nEstablish and maintain manufacturing documentation frameworks - BOMs, work instructions, process flow charts, and process controls - ensuring accuracy and regulatory readiness\n\nAuthor and review technical documentation for audits, regulatory submissions, and design history files, acting as subject matter expert during inspections\n\nWhat You Bring\nBS in Mechanical, Electrical, Biomedical, or Manufacturing Engineering; MS desirable (or equivalent experience)\n\n8+ years of engineering experience with advanced skills in process development, Manufacturing Engineering, and industrialization; medical device or highly regulated industry experience strongly preferred\n\nDeep expertise in process characterization, pFMEAs, MVP, IQ/OQ/PQ/PPQ, and TMVs, with a proven track record of owning and leading validation programs end-to-end\n\nComprehensive knowledge of medical device quality regulations including ISO 13485 and FDA quality system regulations, with experience supporting regulatory submissions and audits\n\nAdvanced problem-solving skills; Six Sigma Black Belt strongly preferred; formal project management training or certification (e.g., PMP) is an advantage\n\nDemonstrated experience leading cross-functional engineering projects and mentoring junior engineers; formal or informal people leadership experience is highly regarded\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, California headquarters and reports to the Manufacturing Engineering Manager. The expected salary range for this position is $130,000 to $153,000. 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. We celebrate diversity and are committed to creating an inclusive environment for all employees.","description_format":"text","description_chars":4800,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Life insurance","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":true,"industries":["Cardiovascular Devices"],"lifecycle":[{"event":"open","at":"2026-09-11T13:51:49Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 1","filings_12m":1,"filings_prev_12m":3,"green_card_filings_12m":0,"median_offered_wage_usd":217500,"route":null,"cap_exempt":false,"checked_at":"2026-11-12T07:36:15+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":9,"band":"cold","label":"Long shot","p_open":1,"p_active":0.317,"p_room":0.28,"age_days":141,"expected_fill_days":30,"reasons":["conf:4","win:tail","crowd:"],"computed_at":"2026-11-12T10:38:37Z"},"pay":{"stated_usd_annual":153000,"is_top_pay":false},"html_url":"https://alion.io/job/bivacor-principal-manufacturing-mechanical-engineer","json_url":"https://alion.io/job/bivacor-principal-manufacturing-mechanical-engineer.json","meta":{"generated_at":"2026-11-12T14:44:18Z","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":30638,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-13T00:00:00Z"}},"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":669566},"rest":"https://alion.io/mcp/rest/get_company?id=669566"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbivacor-principal-manufacturing-mechanical-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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%2Fbivacor-principal-manufacturing-mechanical-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%2Fbivacor-principal-manufacturing-mechanical-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/bivacor-principal-manufacturing-mechanical-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbivacor-principal-manufacturing-mechanical-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":744779}},{"tool":"search_jobs","arguments":{"company":"bivacor.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":744779},"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); https://alion.io/mcp with an Alion account has everything. Docs: https://alion.io/developers"}}