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 (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.
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 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.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 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. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.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.US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and 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. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site:
