Process Engineer II

Beckman Coulter Diagnostics; West Sacramento (CA); On-site; USD 74,000 - 90,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Job summary

Beckman Coulter Diagnostics in West Sacramento is hiring a Process Engineer II responsible for investigating manufacturing non-conformances and providing technical support for operations.

The ideal candidate will hold a Bachelor's degree in a relevant field with at least 3 years of experience in medical device manufacturing and possess skills in root cause investigation.

Competitive salary range of $74,000 - $90,000 and comprehensive benefits are offered.

Qualifications

• 3+ years’ experience in medical device manufacturing or related field.
• Experience in regulated environments.
• Excellent communication and problem-solving skills.

Responsibilities

• Investigate manufacturing non-conformances and support timely resolution.
• Provide technical support including design of experiments.
• Support pilot runs and troubleshoot associated deviations.

Skills

Root cause investigation

Problem-solving

Technical communication

Cross-functional teamwork

Education

Bachelor's degree in Microbiology, Biomedical Engineering or related field

Master's degree in a related field

Tools

HPLC

UV-Vis Spectroscopy

Job description

Overview

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

Within Danaher Diagnostics, one of Danaher’s three segments, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. By harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. The Diagnostics Platform of Danaher Corporation works with conviction that every moment matters and realize that behind every test is a patient, waiting for an answer that could change their life. Our 23,000 team members across 6 operating companies globally proudly push the boundaries of what’s possible in safeguarding patient health and improving diagnostic confidence. We develop tools and technologies that set the standard for innovation and impact wherever health care happens—from a family physician’s office to leading trauma hospitals and laboratories. Our teams collaborate in an inclusive environment as we connect our people, processes, and expertise, focused on the world’s biggest health challenges such as cardiac disease, infectious disease, and cancer.

Learn about the Danaher Business System which makes everything possible.

The Process Engineer II is responsible for owning and investigating manufacturing related non-conformances, ensuring timely resolution to maintain on-time product delivery. Additionally, they will support the piloting team in creating small-scale batches that support R&D and manufacturing efforts. This position reports to the Manager, NPI and OEM and is part of the Manufacturing Technical Operations team located in West Sacramento and will be an on-site role.

In This Role, You Will Have The Opportunity To

• Support Internal Quality KPI-Leads and resolve Internal Non-conformance investigations (assessment of non-conforming product, root cause investigations, corrective and preventative actions)
• Provide technical support for Operations (Design of experiments, technical writing, analytical testing (HPLC, UV-Vis Spectroscopy, and bioassay))
• Support Factory OTD and schedule attainment of finished products
• Lead and resolve customer manufacturing related CAPA and PLRA (post launch risk assessment)
• Support manufacturing of pilot runs and troubleshoot associated deviations

The Essential Requirements Of The Job Include

• Bachelor’s degree in Microbiology, Biomedical Engineering, or science related field, with 3+ years’ experience OR Master’s degree in field with 0+ years’ experience
• Experience working in medical device manufacturing, pharmaceutical, or other regulated environment
• Demonstrate skills in root cause investigation, problem solving, implementing corrective actions
• Excellent written and oral communication of technical data and ability to lead productive team meetings
• Work with cross-functional teams to investigate manufacturing defects, perform data analysis, and write informed, risk based technical justifications for product release

It would be a plus if you also possess previous experience in:

• Hands-on laboratory experience in Microbiology, or other biological science, including exposure to biological sample preparation, cell culture, analytical assays such as HPLC, UV-VIS spectrophotometry etc.
• Danaher Business System (visual project management, value stream mapping, standard work) /Lean/Kaizen/6-sigma, Problem Solving Process (PSP)
• Risk management, process validation, design of experiments, and design change

Benefits and Additional Information

Within Danaher Diagnostics, we offer a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info. The salary range or hourly range for this role is $74,000 - $90,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com. Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: 1-202-419-7762 or [e-mail].