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Baxter Logo Baxter · IT - Administration

Sr Manufacturing Engineer

United States, Hayward Employment contract 96000.00 - 132000.00 USD / Year · Job Posted May 30, 2026
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Job Description

The Senior Manufacturing Engineer is a key site operations representative. The ME will be responsible for completing tasks which support the day to day operations and deliverables to the business. The Engineer will support the manufacturing operation from raw materials to finished device, maintain the risk management process and related documentation, and closely interact with product manufacturing to address quality issues and facilitate continuous improvement of product quality. Conduct engineering studies and process improvements to support process validation and contribute to maximizing production performance. Provide engineering support for production assembly equipment, methods and process validation of new and existing equipment. Performs project planning, justification, specification development, and capital projects. Handles vendor interactions, equipment specifications/design, concepts, and contractors. Involved in machine purchase and installations.

Job Responsibility

  • Drive continuous improvement in production performance, quality, and reliability through data-driven analysis, RCFA, FMECA, and statistical tools
  • Provide hands-on technical support for manufacturing equipment and automation, ensuring optimal performance, maintenance, and compliance
  • Lead nonconformance investigations (CAPA/NCR), including root cause analysis, corrective/preventive actions, effectiveness checks, and timely reporting
  • Partner with Manufacturing to implement lean principles and process improvements, supporting process validation (IQ/OQ/PQ), PFMEA, and overall product assembly optimization
  • Maintain accurate, compliant engineering and quality documentation and prepare failure analysis reports
  • Manage and support projects within budget and operational constraints, including capital planning
  • Monitor and improve key production metrics through daily engagement with manufacturing
  • Ensure compliance with safety, GMP, and environmental regulations
  • Complete all required project updates, training, and administrative deliverables in a timely and accurate manner

Requirements

  • Bachelor’s degree in Science of Mechanical, Biomedical or Electrical Engineering
  • 3-5 years of experience in the Maintenance/Engineering field in a Pharmaceutical or Medical device manufacturing industry, preferred
  • Experience with statistical analysis as Minitab or SAS, preferred
  • Experience with Microsoft Office Suite
  • Green Belt, Black Belt or PMP certification preferred
  • Ability to identify, define, and solve complex problems using a data-driven problem solving approach (i.e. DMAIC)
  • Technical writing ability for protocol generation, execution, and reporting to qualify processes and equipment
  • Strong technical skillset in design for manufacturability (DFM), EH&S guidelines, GMP/GDP guidelines, and process validation
  • Excellent problem-solving, organizational, analytical and critical thinking skills
  • Effective communication and interpersonal skills at all levels
  • Must have very strong verbal and written communication skills, documentation practices (cGDPs), and be self-motivated
  • Must be able to update procedures and modify processes to simply complexity and improve efficiencies
  • Must be able to present project overviews and other departmental presentations without assistance

Nice to have

  • Green Belt, Black Belt or PMP certification
  • Experience with statistical analysis as Minitab or SAS
  • 3-5 years of experience in the Maintenance/Engineering field in a Pharmaceutical or Medical device manufacturing industry

What we offer

  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • Educational assistance programs
  • Paid holidays
  • Paid time off ranging from 20 to 35 days based on length of service
  • Family and medical leaves of absence
  • Paid parental leave
  • Commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
  • Childcare benefits
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