Sr. Engineer

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission.

Your role at Baxter:

The Senior Manufacturing Engineer (ME) 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 design and vigilance functions 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 products. Performs project planning, justification, specification development, and budgeting. Handles vendor interactions, equipment specifications/design, concepts, and vendor negotiations. Oversees machine purchase and installations, as well as the building of whole machines or processes.

The position supports the sustaining of production processes in a state of control and compliance through the planning, execution and implementation of process validation and controls to meet regulatory agency validation requirements, internal company standards and current industry practices. Authors and reviews validation processes and procedures, making recommendations for changes and/or improvements.

What you'll be doing:

• Contribute to continuous improvements in overall product cost and quality.
• Provide technical support for production tools including assembly equipment and automation.
• Maintain documentation associated with manufacturing processes.
• Lead and Collaborate with CAPA and NCR investigation of nonconformances. Identify root cause, corrective action, preventive action, monitoring plan and the overall effectiveness for resolution of CAPA and NCR issues while applying problem-solving methodologies.
• Drive execution of CAPA deliverables through monitoring and reporting status to CAPA Review Board and management in a timely manner. Ensure compliance to requirements and consistency/quality of CAPA execution.
• Develop, monitor, analyze and improve reliability, lead Root Cause Failure Analysis (RCFA) and Failure Mode & Effect and Criticality Assessment (FMECA) efforts.
• Partner with Manufacturing to develop lean principals to implement solutions for product assembly.
• Conduct coordinate and aid in formal Process Validations including protocol development and execution.
• Support project team members in achieving business objects related attainment of Safety, Quality, Service, and Project Schedule and Cost goals.
• Follow established procedures to perform detailed, accurate, and compliant engineering documentation for Master Validation Plans, PFMEA, Equipment Installation, Characterization, Qualification and Validation activities.
• Daily interaction with manufacturing providing hands-on support and responsibility for metrics such as labor time, lead-time, capability, and yield.
• Complete on time project updates, project hours, development plans, self-assessments, and successful completion of all training requirements.
• Application of statistical tool like Minitab to perform statistical analysis using tools such as SPC, SQC and DOE.
• Using data acquisition tools as Infinity QS, to evaluate all relevant operational data, reports, statistics and documentation related to manufacturing equipment and systems in order to generate proactive and timely actions to optimize manufacturing process.
• Prepare failure analysis reports, concentrating on identifying repetitive occurrences of failures of critical equipment and processes.
• Project management within budgetary and manufacturing constraints including budgeting of capital and expense dollars for shop floor support and helping establish long range plans for areas of responsibility.
• Ensure a safe work environment is maintained through adherence to safety guidelines and policies and ensure compliance with CA state and federal EPA regulation and laws.
• Specific responsible system repairs, upkeep, maintenance and operations managed within regulating agencies.
• Ensure all mandatory training requirements are met, including annual EHS training, GMP refresher training and any applicable training requirements for all employees.

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 Medical Device, Pharmaceutical or Chemical Process Industry is desired.
• Have proven experience using statistical analysis with tools as Minitab or SAS.
• 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).
• Developing complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports.
• Strong technical skillset in the area of manufacturing engineering: design for manufacturability (DFM), EH&S guidelines, FDA 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.
• Proven expertise in Microsoft Office Suite and manufacturing systems.
• Must have very strong verbal and written communication skills, documentation practices (cGDPs), be self-motivated and possess strong interpersonal skills.
• Must be able to update procedures and modify processes to simply their complexity and improve efficiencies.
• Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
• Must have passion to innovate and drive for solutions.
• Must display personal accountability for results and integrity.
• Must display eagerness to learn and continuously improve.
• Must have uncompromising dedication to quality.
• Must have relentless focus on rapid and disciplined action.
• Must have respect for individuals and the diverse contributions of all.
• Must have be results oriented with a high level of energy.
• Must be able to present project overviews and other departmental presentations without assistance.
• Must demonstrate the ability to learn new material quickly and demonstrate high potential for continued professional growth within Engineering.

The physical activity of this position

• Climbing. Ascending or descending ladders, stairs, scaffolding, ramps, poles and the like, using feet and legs and/or hands and arms. Body agility is emphasized. This factor is important if the amount and kind of climbing required exceeds that required for ordinary locomotion.
• Standing. Particularly for sustained periods of time.
• Walking. Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another.
• Talking. Expressing or exchanging ideas by means of the spoken word. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly.
• Hearing. Perceiving the nature of sounds at normal speaking levels with or without correction. Ability to receive detailed information through oral communication, and to make the discriminations in sound.

The physical requirements of this position

• Light work. Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the worker sits most of the time, the job is rated for light work.

The visual acuity requirements including color, depth perception, and field vision

• The worker is required to have visual acuity to determine the accuracy, neatness, and thoroughness of the work assigned (i.e., custodial, food services, general laborer, etc.) or to make general observations of facilities or structures (i.e., security guard, inspection, etc.).

The conditions the worker will be subject to in this position

• The worker is subject to hazards. Includes a variety of physical conditions, such as proximity to moving mechanical parts, moving vehicles, electrical current, working on scaffolding and high places, exposure to high heat or exposure to chemicals.

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 our employees, and we strive to be more transparent with our pay practices. To that end, this position has a base salary range of $60,000 to $132,000, plus an annual incentive bonus. The above range represents the expected base salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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.

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

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 here and 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 .