Sr Manufacturing Engineer

Senior Manufacturing Engineer – Baxter

The Senior Manufacturing Engineer is a key site operations representative responsible for supporting the manufacturing operation from raw materials to finished devices. The Engineer maintains the risk management process and related documentation, interacts with product manufacturing teams to address quality issues, and facilitates continuous improvement of product quality. The role also includes conducting engineering studies and process improvements to support process validation and maximize production performance.

• Drive continuous improvement in production performance, quality, and reliability through data‑driven analysis, RCFA, FMECA, and statistical tools (SPC, SQC, DOE, Minitab, Infinity
  
  QS).
• 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 (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.

• Bachelor’s degree in Mechanical, Biomedical, or Electrical Engineering.
• 3‑5 years of experience in Maintenance/Engineering in a Pharmaceutical or Medical device manufacturing industry, preferred.
• Experience with statistical analysis tools such as Minitab or SAS, preferred.
• Experience with Microsoft Office Suite and Green Belt, Black Belt or PMP certification preferred.
• Ability to identify, define, and solve complex problems using a data‑driven problem‑solving approach (DMAIC).
• Technical writing ability for protocol generation, execution, and reporting to qualify processes and equipment.
• Strong technical skill set in 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.
• Strong verbal and written communication skills and documentation practices (cGDPs). Self‑motivated and able to update procedures and modify processes to reduce complexity and improve efficiencies.
• Ability to present project overviews and departmental presentations without assistance.
• Must be authorized to work for any employer in the United States.

Estimated base salary: $96,000 – $132,000 annually. Eligible for discretionary bonuses.

Benefits include: medical and dental coverage beginning day one; life, accident, short‑term and long‑term disability; business travel accident insurance; 401(k) plan with company matching;
Employee Stock Purchase Plan (ESPP); flexible spending accounts; paid holidays and paid time off ranging from 20–35 days; paid parental leave; commuter benefits;
Employee Assistance Program (EAP); and childcare benefits.

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.