{"id":1905013,"url":"https://alion.io/job/lifecore-biomedical-senior-design-quality-engineer","title":"Senior Design Quality Engineer","company":{"id":2341566,"name":"Lifecore Biomedical","domain":"lifecore.com","url":"https://alion.io/company/life-core","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":{"grade":"A","score":100,"open_postings":3,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":33,"computed_at":"2026-10-21T05:46:15Z"}},"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":["Chaska, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":83000,"max_usd":156000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":5966},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-03T14:00:00Z","employer_posted_date":"2026-10-07","last_verified_at":"2026-10-21T14:55:19Z","board_verified":true,"closed_at":null,"days_open":48,"trust":{"level":"ok","repost_count":1,"flags":[],"days_open":47},"description":"It's not what we make, it's what we make possible. And the possibilities at Lifecore are endless!\nThis full-time position offers incredible benefits, your choice of a 4 ½ or 5 day work week, and a company culture focused on development and growth which include promotion opportunities.\nWe are seeking a Senior Design Quality Engineer to join our MS&T team. In this role, you will provide quality engineering leadership and expertise to technical development programs, new business programs, and customer-facing product development activities. This role partners closely with cross-functional teams and customers to ensure quality is embedded throughout the product development lifecycle through the application of Quality by Design (QbD) principles and Design of Experiments (DOE). You will support the identification of quality, regulatory, and validation requirements early in development to facilitate robust product and process design while effectively meeting customer and business objectives.\nIn this critical engineering role, you will:\nMaintain knowledge of best industry practices to provide quality oversight and related initiatives for process development.\nEnsure validation strategies for clinical and commercial products are developed and executed in compliance with regulatory requirements, supporting robust processes and consistent product quality. \nEnsure development programs comply with the Quality System and all Design Control requirements.\nUse quality engineering concepts to monitor, support and critically review process development efforts.\nReview and approve experimental plans, development processes, equipment/process qualification and controlled documentation.\nMentor good experimental technique and statistical/technical data analysis.\nEnsure data is reviewed and trends are investigated in a manner that ensures robust process quality. \nProvide guidance in structure of product development process documentation.\nThis position could be a great fit for you if you have a passion for quality, and the following:\nBS in Engineering or Life Sciences \n5-8 years of quality assurance or quality engineering experience in the medical device or pharmaceutical industry \nQuality engineering support experience for process improvement or process development.\nExperience in process/equipment validation.\nComprehensive understanding of GMP regulations for medical devices, pharmaceutical products and active pharmaceutical ingredients.\nIn depth understanding of common process development and engineering development activities and proficient in experimental statistical and design of experiments.\nIn depth understanding of design control and regulatory requirements for process design and transfer.\nIn depth understanding of current good manufacturing practices (cGMP) and typical regulatory concerns affecting medical device and/or drug manufacturing.\nStarting Salary: $95,000 - $115,00 annually with consideration for relevant skills and experience\nLifecore offers a highly competitive total rewards package, including:\nOpportunities to learn and grow with a well-respected company\nCompetitive compensation with annual reviews and a company-wide incentive bonus\nBenefits that start the first of the month after you join Lifecore as a full-time employee:3 medical insurance plans to fit your needs and budget including an HSA Plan with company contributions.\nLow cost dental and vision insurance\nShort term disability, long term disability and life insurance all 100% company paid\n3 weeks PTO in the first year (increases to 4 weeks after just 2 years!)\n9 paid company holidays plus 2 personal holidays\nPaid family leave\nTuition reimbursement\n401k plan with company matching contribution\n\nMeet Lifecore Biomedical, LLC:\nLifecore Biomedical, Inc. (Nasdaq: LFCR) is a fully integrated contract development and manufacturing organization (CDMO) that offers highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceutical products in syringes, vials, and cartridges, including complex formulations. As a leading manufacturer of premium, injectable-grade hyaluronic acid, Lifecore brings more than 40 years of expertise as a partner for global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories.","description_format":"text","description_chars":4301,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Health insurance","Life insurance","Parental leave","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Health & Medical Electronics","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-05T12:36:04Z"},{"event":"close","at":"2026-10-06T21:02:03Z"},{"event":"reopen","at":"2026-10-07T23:48:12Z"}],"visa":[],"liveness":{"score":35,"band":"fade","label":"Fading","p_open":1,"p_active":0.641,"p_room":0.55,"age_days":47,"expected_fill_days":33,"reasons":["conf:1","win:tail"],"computed_at":"2026-10-21T05:46:15Z"},"pay":null,"html_url":"https://alion.io/job/lifecore-biomedical-senior-design-quality-engineer","json_url":"https://alion.io/job/lifecore-biomedical-senior-design-quality-engineer.json","meta":{"generated_at":"2026-10-21T19:58:41Z","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":28342,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-22T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"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":2341566},"rest":"https://alion.io/mcp/rest/get_company?id=2341566"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Flifecore-biomedical-senior-design-quality-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"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%2Flifecore-biomedical-senior-design-quality-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"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%2Flifecore-biomedical-senior-design-quality-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/lifecore-biomedical-senior-design-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Flifecore-biomedical-senior-design-quality-engineer"}]}