{"id":4300514,"url":"https://alion.io/job/vitalbio-senior-manufacturing-engineer","title":"Senior Manufacturing Engineer","company":{"id":2134020,"name":"Vitalbio","domain":"vitalbio.com","url":"https://alion.io/company/vitalbio","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Teamtailor","truth_index":null},"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":["Oakville, Canada"],"countries":["CA"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"Design of Experiments","optional":false},{"name":"FMEA","optional":false},{"name":"GMP","optional":false},{"name":"ISO 13485","optional":false},{"name":"JMP","optional":false},{"name":"Minitab","optional":false},{"name":"Statistical Process Control","optional":false}],"status":"live","first_seen_at":"2026-11-07T00:36:39Z","employer_posted_date":"2026-11-07","last_verified_at":"2026-11-14T02:57:31Z","board_verified":true,"closed_at":null,"days_open":7,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":7},"description":"About you:\nYou are a hands-on, technically driven manufacturing engineer who thrives where product development, automation, and operations meet. You have a proven track record of leading complex product transfers and scaling robust, high quality manufacturing processes in a cGMP regulated environment. You balance strategic thinking with a willingness to get into the details, use data to solve difficult problems, and guide others toward practical, sustainable solutions. You are ready to take technical ownership of critical manufacturing programs and help Vital Bio bring diagnostics to life.\nWhat you'll do:\nServe as the technical lead for complex manufacturing engineering programs, owning process strategy and execution from development through production scale-up and sustaining operations.\n\nLead cross-functional technology transfers from R&D engineering and assay development into cGMP manufacturing, defining key deliverables, technical risks, and manufacturing readiness criteria.\n\nDesign, develop, document, and optimize scalable manufacturing processes for consumable assemblies combining reagents with molded plastic components, as well as diagnostic instruments.\n\nProvide design for manufacturability / assembly feedback to influence product designs for automation readiness, quality, yield, and cost effectiveness.\n\nDevelop manufacturing and automation strategies, including process flow maps, assembly sequencing, Make/Buy evaluations, equipment selection, and third party transfers.\n\nLead critical equipment projects from user requirements and supplier selection through installation, qualification (IQ, OQ, PQ), and production handover.\n\nOwn process characterization, risk assessments (including pFMEA), and manufacturing control strategies; apply DOE, SPC, and data analysis to establish robust and repeatable processes.\n\nPlan and lead validation activities for equipment, processes, and test methods (IQ, OQ, PQ, and TMV), partnering with Quality to meet ISO 13485, FDA 21 CFR 820, and cGMP requirements.\n\nProvide technical leadership during complex manufacturing investigations, driving root cause analysis, corrective actions, and sustainable resolution of process or equipment issues.\n\nIdentify and drive continuous improvement opportunities to increase throughput, improve yield and equipment reliability, and reduce manufacturing cost.\n\nCollaborate with R&D engineering, assay development, manufacturing, Quality, and Supply Chain to resolve technical challenges and support verification, validation, and production needs.\n\nMentor manufacturing engineers and technicians, provide technical reviews and guidance, and promote sound engineering practices across the team.\n\nWhat you need:\nBachelor’s degree in a STEM discipline.\n\n8+ years of progressive manufacturing engineering experience in diagnostics, medical devices, or a similar regulated industry; experience with reagents and injection-molded components is strongly preferred.\n\nDemonstrated success leading complex manufacturing process development, tech transfer, automation, or production scale-up projects from concept through sustained operation.\n\nStrong knowledge of cGMP manufacturing, ISO 13485, and equipment/process validation and qualification requirements (IQ/OQ/PQ/TMV).\n\nProficiency in structured problem solving, process risk management (pFMEA), statistical process control (SPC), design of experiments (DOE), and data analysis (Minitab, JMP, or Excel).\n\nExperience developing and reviewing user requirements, process documentation, validation protocols, SOPs, work instructions, and manufacturing control plans.\n\nProven ability to provide technical leadership, collaborate across functions, and mentor less-experienced engineers without relying on formal authority.\n\nExcellent communication skills, sound technical judgment, and the ability to translate complex engineering issues into clear, actionable recommendations.\n\nStrong organizational skills and the ability to prioritize and drive multiple high-impact projects in a fast-paced environment.\n\nBonus points for:\nSix Sigma and/or Lean certification, with demonstrated experience leading practical process improvement initiatives.\n\nExperience specifying, integrating, and qualifying high-volume automated assembly, dispensing, or inspection equipment.\n\nFamiliarity with microfluidics, reagent-based consumables, and global IVD manufacturing regulations.\n\nExperience managing capital equipment suppliers, technical project budgets, and external manufacturing partners.\n\nAn appreciation for puns and a willingness to pitch in wherever needed!\n\nWhy Join Us?\nAt Vital Bio, you will:\nTake a critical role in building and scaling manufacturing operations for novel diagnostics, impacting global healthcare systems.\n\nWork alongside passionate problem-solvers in a culture that values curiosity, teamwork, and innovation.\n\nOwn your contributions on projects with meaningful, real-world outcomes.\n\nGrow your skills in a supportive, dynamic environment that believes fun and excellence go hand-in-hand.\n\nCompensation will be determined based on the individual’s demonstrated experience, education, training, relevant certifications or licensure, and other applicable business and organizational factors.\nThis role is a current, onsite vacancy.\nAbout Vital Bio\n\nVital is revolutionizing point-of-care diagnostics with our VitalOne platform, delivering real-time care wherever patients are. Our mission is to democratize health technology, making healthcare more accessible and proactive.\nOur global team of experts spans chemistry, software, engineering, and microfluidics. We thrive on change, operate on trust, and value diverse perspectives. Our growth-minded culture empowers front-line decision-making and fosters impactful work.\nWe seek tenacious, bold individuals ready to transform healthcare. At Vital, your talent will make a difference as we work to ensure everyone has access to care when and where they need it.\n\nVital Biosciences Inc. is an equal opportunity employer and values diversity in the workplace. We are therefore happy to accommodate any individual needs in keeping with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act. If you require accommodation in order to participate in our hiring process, please contact us to make your needs known in advance\n\nAs part of our recruitment process, we may use automated or AI-supported tools to assist with application review and screening. These tools are used to support, not replace, human decision-making. Final hiring decisions are always made by our hiring team.","description_format":"text","description_chars":6613,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-11-14T02:57:31Z"}],"visa":[],"liveness":{"score":81,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.854,"p_room":0.945,"age_days":7,"expected_fill_days":17,"reasons":["conf:2","win:mid"],"computed_at":"2026-11-14T05:01:02Z"},"pay":null,"html_url":"https://alion.io/job/vitalbio-senior-manufacturing-engineer","json_url":"https://alion.io/job/vitalbio-senior-manufacturing-engineer.json","meta":{"generated_at":"2026-11-14T05:01:02Z","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":8299,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-15T00:00:00Z"}},"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":2134020},"rest":"https://alion.io/mcp/rest/get_company?id=2134020"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fvitalbio-senior-manufacturing-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"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%2Fvitalbio-senior-manufacturing-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%2Fvitalbio-senior-manufacturing-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/vitalbio-senior-manufacturing-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fvitalbio-senior-manufacturing-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4300514}},{"tool":"search_jobs","arguments":{"company":"vitalbio.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4300514},"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. 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