Sr Manufacturing Engineer

About the Role

The Senior Manufacturing Engineer is a key site operations representative who supports day‑to‑day operations and deliverables to the business. The engineer oversees the full manufacturing lifecycle from raw materials to finished device, maintains risk management processes, addresses quality issues in collaboration with product manufacturing, and drives continuous improvement of product quality.

• Drive continuous improvement in production performance, quality, and reliability through data‑driven analysis, RCFA, FMECA, and statistical tools such as SPC, SQC, DOE, Minitab, and Infinity
  
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• 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 environment.
• Experience with statistical analysis tools such as Minitab or SAS.
• Experience with Microsoft Office Suite.
• Green Belt, Black Belt, or PMP certification is preferred.
• Ability to identify, define, and solve complex problems using a data‑driven approach (e.g., DMAIC).
• Technical writing skills for protocol generation, execution, and reporting.
• Strong technical skillset in manufacturing engineering, including 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 with solid documentation practices.
• Ability to update procedures and modify processes to reduce complexity and improve efficiencies.
• Ability to present project overviews and departmental presentations independently.

Estimated base salary $96,000 – $132,000 annually. Potential discretionary bonuses may apply. Benefits include medical, dental, vision, basic life, accidental, short‑term and long‑term disability, and business travel accident insurance, as well as 401(k) and employee stock purchase plan. Other benefits include flexible spending accounts, educational assistance, paid holidays, and paid time off, among others.

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.

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.

Baxter is committed to providing reasonable accommodations to qualified applicants with disabilities. If you need an accommodation throughout the application or interview process, please let us know.