Sr Manufacturing Engineer

Baxter International Inc.•Hayward, CA

1d•$96,000 - $132,000•Onsite

About The Position

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. 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.

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 with tools as Minitab or SAS, preferred
Experience with Microsoft Office Suite
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 the area of manufacturing engineering: 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 of employees, suppliers, and consultants.
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.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Nice To Haves

Green Belt, Black Belt or PMP certification preferred.

Responsibilities

Drive continuous improvement in production performance, quality, and reliability through data-driven analysis, RCFA, FMECA, and statistical tools (SPC, SQC, DOE, Minitab, InfinityQS).
Provide hands-on technical support for manufacturing equipment and automation, ensuring optimal performance, maintenance, and compliance with regulatory and safety requirements.
Lead nonconformance investigations (CAPA/NCR), including root cause analysis, corrective/preventive actions, effectiveness checks, and timely reporting to review boards and management.
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 (e.g., validation plans, protocols, reports) and prepare failure analysis reports to prevent recurring issues.
Manage and support projects within budget and operational constraints, including capital planning, while delivering on Safety, Quality, Service, Cost, and Schedule objectives.
Monitor and improve key production metrics (labor, yield, lead time, capability) through daily engagement with manufacturing and proactive data analysis.
Ensure compliance with safety, GMP, and environmental regulations, including EHS standards, required training, and oversight of regulated systems and operations.
Complete all required project updates, training, and administrative deliverables in a timely and accurate manner.

Benefits

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), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
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