Sr Manufacturing Engineer Job at Baxter (Hayward)

Job Description

Being an Engineer at Baxter means you play a critical role in helping us achieve our mission to save and sustain lives. From innovative product design through to production and patient delivery, our Engineers are key to delivering results for our customers and patients worldwide. 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 (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

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
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 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.

Nice to have

Green Belt, Black Belt or PMP certification
Experience with statistical analysis with tools as Minitab or SAS

What we offer

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
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
Childcare benefits
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Baxter - All Job Offers

Select Country

Sr Manufacturing Engineer

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

Looking for more opportunities?

Sr Manufacturing Engineer

Engineer / Sr Engineer, Manufacturing Sciences & Technology (mRNA/LNP)

Sr. Manager, Industrial Engineering

Sr Engineer 1, Facilities & Utilities

Sr Software Engineer

Sr. Associate Manufacturing Production Process Owner

Sr. Software Engineer (Medical Devices)

Sr. D365 Functional Manufacturing Consultant

Sr. Staff Mechanical Design Engineer

Our AI answers in your language