Senior Engineer Manufacturing

This is whereyour work makes a difference.

At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job-you will find purpose and pride.

Your Team at Baxter:

As a Sr. Manufacturing Engineer at Baxter plays a critical role in optimizing manufacturing processes and ensuring the efficient production of high-quality medical devices. This role requires a strong background in engineering principles, manufacturing processes, and project management. They work alongside diverse departments to drive continuous improvement initiatives, implement new technologies, and improve operational efficiency.

In this role you will support several production lines within the Final Assembly Department. You will partner with cross - functional operations team members (i.e. Production Supervisor, Quality Assurance Engineer, and Materials Planning) to effectively identify, investigate and resolve manufacturing process related issues. In addition, you will lead ongoing improvement efforts in support of departmental, site and corporate objectives for Safety, Quality, Delivery, Efficiency, and Cost Performance.

What you'll be doing:

• Provide technical expertise and support to manufacturing teams for 10-12 medical device manufacturing assembly lines (e.g. Electronics, Machining, Plating, Manual Assembly), troubleshooting and resolving production issues.

• Develop and maintain manufacturing process documentation such as Manufacturing Process Specifications, Device History Records, Tooling/Equipment Specifications, Preventative Maintenance, and Calibration procedures through the Engineering Change Management (ECM) process.

• Conduct root cause analysis and implement corrective actions to address process deviations and equipment failures.

• Develop and execute Process and Equipment Validation/Verification Strategies for new or changing manufacturing process elements.

• Develop and execute Engineering Builds and assist with Material Qualification Planning to support new or changing component requirements.

• Perform and document Impact Assessments and Corrective Actions for Equipment Remediation's associated with out of tolerance calibration results.

• Analyze and improve manufacturing processes to enhance efficiency, reduce waste, and increase productivity.

• Develop and implement process control strategies to ensure consistent product quality and compliance with regulatory standards.

• Lead and manage engineering projects from conception through implementation, ensuring they are completed on time and within budget.

• Collaborate with cross-functional teams, including production, quality assurance, and supply chain, to align project goals with business objectives.

• Prepare and maintain accurate documentation related to manufacturing processes, including work instructions, process flows, and validation protocols.

• Guarantee alignment with all relevant safety regulations, industry standards, and company policies.

• Identify and implement continuous improvement initiatives using Lean, Six Sigma, and other methodologies to enhance manufacturing performance.

• Monitor key performance indicators (KPIs) and develop action plans to achieve operational goals.

• Mentor and train junior engineers and manufacturing staff on best practices, process improvements, and new technologies.

• Foster a culture of learning and development within the engineering team.

• Perform other duties as assigned by management to support the overall goals of the quality team.

• Proactively contributes to zero harm in the workplace by always following legal and corporate Environmental Health & Safety requirements. This includes safe work practices and EHS policies and procedures that protect every employee.

• Report all hazards, near misses and incidents as soon as practicable and participate in identifying actions to prevent harm from occurring to our people and/or our environment.

• Employees at every level are responsible for quality (GMP) Good Manufacturing Processes and regulatory performance in the department to ensure quality program is met.

• Ensure compliance with FDA, ISO and other government regulations, legal documents and safety and ethical standards, obtaining legal compliance training.

• Ensure that all testing activities comply with relevant regulatory standards and quality management systems (e.g., ISO 13485, FDA regulations).

• Report any safety concerns or incidents to management in a timely and accurate manner

What you'll bring:

• Bachelor's degree in mechanical engineering, Industrial Engineering, Manufacturing Engineering, or a related field; a master's degree is preferred.

• Minimum of 3-7 years of experience in manufacturing engineering or a related field, preferably in a regulated industry such as medical devices or pharmaceuticals.

• Proven experience in project management and process improvement initiatives.

• Experience in the Medical Device or a similar regulated industry is preferred.

• Strong knowledge of manufacturing processes, equipment, and technologies.

• Proficient in CAD software and manufacturing simulation tools. SAP, CAD modeling, Schematic drafting, PLC & CNC programming experience is a plus.

• Excellent analytical and problem-solving skills, with the ability to work under pressure.

• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.

• OSHA certification (e.g., 30-hour or 40-hour), Other certifications (e.g., biomedical engineering, electrical engineering) and Lean Six Sigma certification or equivalent.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee:

• Must be able to sit for long periods of time

• Must have good hand to eye coordination and dexterity

• Physical Requirements: Dynamic Lifting capability: Must have the ability to lift 40 pounds at a time.

WORK ENVIRONMENT

Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to:

• Wearing a static protective smock at all times while in the work area

• Wearing a ground wrist strap and plugging that wrist strap into the working table.

• Working in close proximity to other employees.

• Working in an environment that is temperature and humidity controlled.

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 - $115,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses, commission, and/or long-term incentive. 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.

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: Benefits | Baxter

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.

Know Your Rights: Workplace Discrimination is Illegal

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 click on the link here and let us know the nature of your request along with your contact information.

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