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Sr Manufacturing Engineer

$96k - $132k

Baxter Healthcare

This is where your work makes a difference. Your Role 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. What You'll Be Doing 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 (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. What You'll Bring 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 tools such 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 eliminate complexity and improve efficiencies. Must be able to present project overviews and other departmental presentations without assistance. Compensation & Benefits The estimated base salary for this position is $96,000 – $132,000 annually. The estimated salary is meant to reflect an anticipated salary range for the position. Pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. Additional benefits include medical and dental coverage, life and disability insurance, a 401(k) retirement savings plan, flexible spending accounts and educational assistance, paid time off, family and medical leave, paid parental leave, commuting benefits, employee discount program, employee assistance program and childcare benefits. Equal Employment Opportunity 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. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. #J-18808-Ljbffr Baxter Healthcare

Vacancy posted 2 days ago
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