Sr. Manager, Global Process Engineering

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology

AtBeckman Coulter Diagnostics one ofDanahers15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. Andby harnessingDanahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.

As a global leader in clinical diagnostics Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratorys role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing and are used in hospitals reference and research laboratories and physician offices around the world. Every hour around the world more than one million tests are run on Beckman Coulter Diagnostics systems impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough to rapid and reliable sample analysis to more rigorous decision makingwe are enabling clinicians to deliver the best possible care to their patients with improved efficiency clinical confidence adaptive collaboration and accelerated intelligence.

Learn about theDanaher Business Systemwhich makes everything possible.

TheSr.ManagerGlobal ProcessEngineeringis responsible forleading andshaping our manufacturing capabilities and ensuring the highest standards of quality and efficiency in medical device production. You will lead a team of talented engineers overseeing the development optimization and validation of manufacturing processes from concept to commercialization. This role requires a strategic thinker with deep technical expertise exceptional leadership skills and a strong commitment to regulatory compliance within the medical device industry.

This position reports to the VP Global Engineering and is part of the Global Engineering team. This will be a remoteposition preferably near ChaskaMinnesotaornearan airport for travel.

• Strategic Leadership & Management: Lead mentor and develop a highperforming Process Engineering team fostering a culture of continuous improvement accountability and technical excellence.

• Process Development:Define and execute process engineering strategies aligned with business objectives including production efficiency cost reduction quality improvement and new product introduction (NPI).

• Validation:Oversee the design development and optimization of scalable costeffective manufacturing processes for new and existing medical device products using Lean and Six Sigma methodologies.

• Optimization:Oversee the design development and optimization of scalable costeffective manufacturing processes for new and existing medical device products using Lean and Six Sigma methodologies.

• Financial Acumen:Manage departmental budgets resources and project prioritization to ensure effective execution of strategic and operational goals.

• Compliance:Ensure full compliance with FDA 21 CFR Part 820 ISO 13485 and global regulatory requirements including ownership of process validation (IQ/OQ/PQ) documentation and audit support

• Cross-functional Collaboration:Collaborate crossfunctionally with R&D Quality Operations Supply Chain and Regulatory teams to support technology adoption equipment implementation and successful product transfers.

The essential requirements of the job include:

• Education:Bachelors degree in Engineering(Biomedical Mechanical Electrical Industrial Manufacturing) or a closely related technical field;Mastersdegree or MBA preferred.

• Experience:10 years of experience in Process Engineering within a regulated medical device manufacturing environment.

• Leadership Experience:5 years of people leadership experience including managing developing and mentoring engineering teams.

• Technical Skills:Demonstrated expertise in FDA 21 CFR Part 820 ISO 13485 and applicable global medical device regulatory requirements.

• Methodologies:Proven success leading process improvement initiatives supported by Lean Six Sigma methodologies and certifications (Green or Black Belt preferred).

• Technical Skills:Strong technical background in process validation (IQ/OQ/PQ) statistical process control (SPC) and datadriven manufacturingdecisionmaking.

• Industry Knowledge:Experience across complex manufacturing processes (e.g. injection molding assembly sterilization packaging automation and/or cleanroom operations) withstrong communication project management and cross-functional collaboration skills.

Travel Motor Vehicle Record & Physical/Environment Requirements: if applicable for role

• Ability to travel60-70%travelif remote work arrangement40-50% if on-site/hybrid

• Must have a valid drivers license with an acceptable driving record

Beckman Coulter Diagnosticsa Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits atDanaher Benefits Info.

AtBeckman Coulter Diagnosticswe believe in designing a better more sustainable workforce. We recognize the benefits of flexible remote working arrangements for eligible roles and are committed to providing enriching careers no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working forBeckman Coulter Diagnosticscan provide.