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Medtronic
Medtronic
H1B vizos rėmėjasGamybaSveikatos draudimasSveikatos priežiūra
„Medtronic“ yra pasaulinė sveikatos priežiūros technologijų ir gamybos įmonė, kurianti sprendimus sudėtingoms medicininėms būklėms gydyti. Jos veikla apima dideles tarptautines komandas ir glaudų bendradarbiavimą su sveikatos priežiūros specialistais, siekiant gerinti gydymą, terapijas ir medicinos technologijų prieinamumą. Daugiau nei 95 000 darbuotojų daugiau kaip 150 šalių turinti „Medtronic“ daugiausia dėmesio skiria pacientų priežiūros pažangai, taip pat puoselėja įtrauktį, įvairovę, lygybę ir tvarią veiklą visose savo operacijose.
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Senior Microbiologist and Sterilization Engineer – Medtronic, Fridley, MN

Medtronic seeks a senior microbiologist and sterilization engineer for its onsite Fridley operation. The role leads sterility assurance, validation, contamination control, investigations, audits, and release support in regulated medical-device manufacturing.

USJungtinės ValstijosMNMinesota
98 400 $ – 147 600 $ / metai
Darbas vietojeVisas etatasVyresnysis specialistasPrivaloma Kalba: anglųInžinierius

Aprašymas

  • Lead microbiology and sterility-assurance programs for terminally sterilized medical devices
  • Validate, qualify, requalify, monitor, and technically review ethylene oxide and radiation sterilization processes
  • Serve as a technical authority on controlled environments and contamination-control practices
  • Support cleanroom qualification, environmental and utility monitoring, bioburden, endotoxin, particulate, sterility, and ethylene oxide residual testing
  • Open, support, and review microbiology investigations, nonconformances, issue-triage records, and CAPAs
  • Use risk-based analysis to identify causes, evaluate product impact, establish containment and corrective actions, and confirm effectiveness
  • Trend microbiology and sterilization results and prepare periodic reviews, quality metrics, and management-review materials
  • Evaluate changes to products, materials, suppliers, manufacturing, packaging, facilities, utilities, equipment, and controlled environments for sterility-assurance effects
  • Create and maintain protocols, reports, risk assessments, procedures, work instructions, and technical rationales
  • Work cross-functionally with Quality, Operations, Engineering, Facilities, laboratories, suppliers, contract sterilizers, and product-development teams
  • Contribute to quality-event resolution, release decisions, product launches and transfers, audits, inspections, and compliance programs
  • Maintain inspection readiness while advancing standardization and continuous improvement across regional microbiology and sterility-assurance processes

Reikalavimai

  • Bachelor’s degree with at least four years of relevant experience, master’s degree with at least two years, or PhD with no required experience
  • A bachelor’s degree earned outside the United States must meet the standard specified in 8 C.F.R. § 214.2(h)(4)(iii)(A)
  • Background in medical devices, pharmaceuticals, biotechnology, or another highly regulated sector
  • Practical experience applying cGMP and quality-system requirements
  • Hands-on experience with industrial ethylene oxide and/or radiation sterilization
  • Strong knowledge of controlled environments, contamination control, monitoring programs, bioburden, endotoxin or sterility testing, or microbiological product-impact evaluation
  • Working knowledge of FDA requirements and applicable ISO, AAMI, and USP guidance, including ISO 13485, 11135, 11137, 11737, 14644, 14698, 17664, and 17665
  • Experience handling microbiology or sterilization investigations, NCMRs, CAPAs, issue triage, root-cause analysis, risk assessment, and effectiveness checks
  • Ability to interpret complex data trends and communicate findings through technical reports, dashboards, and management or Tier reviews
  • Experience writing and reviewing validation protocols, reports, periodic reviews, procedures, work instructions, regulatory responses, and inspection-ready documentation in electronic quality or document systems
  • Ability to manage competing compliance and business priorities independently, influence cross-functional partners, and coordinate work across sites, laboratories, suppliers, and contract sterilizers
  • Must have unrestricted U.S. work authorization at hire and throughout employment; sponsorship is unavailable below the Principal level
  • Certification as an Industrial Sterilization Specialist or relevant AAMI, ASQ, Lean, or problem-solving certification is preferred
  • Experience with Excel, Power BI, Minitab, or similar analytical tools is preferred

Privalumai

  • Competitive salary with a flexible benefits package
  • Medtronic Incentive Plan short-term incentive
  • Health insurance
  • Dental insurance
  • Vision insurance
  • Health Savings Account
  • Healthcare Flexible Spending Account
  • Life insurance
  • Long-term disability leave
  • Dependent daycare spending account
  • Tuition assistance or reimbursement
  • Simple Steps global well-being program
  • Additional incentive plans
  • 401(k) plan with employer contribution and matching
  • Short-term disability coverage
  • Paid time off
  • Paid holidays
  • Employee Stock Purchase Plan
  • Employee Assistance Program
  • Non-qualified Retirement Plan Supplement
  • Capital Accumulation Plan for Vice Presidents and above, or for employees meeting applicable IRS earnings thresholds
  • Paid sick time for temporary employees where required by state law
  • Reasonable accommodations for qualified individuals with disabilities

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