Sr. Manager, Global Process Engineering

DanaherChaska, MN
14h$160 - $190Remote

About The Position

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics , one of Danaher’s 15+ operating companies, 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. And by harnessing Danaher’s 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 laboratory’s 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 making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the Danaher Business Syste m which makes everything possible. The Sr. Manager , Global Process Engineering is responsible for leading and shaping 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 remote position , preferably near Chaska, Minnesota or near an airport for travel.

Requirements

  • Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, Industrial, Manufacturing) or a closely related technical field
  • 10+ years of experience in Process Engineering within a regulated medical device manufacturing environment.
  • 5+ years of people leadership experience, including managing, developing, and mentoring engineering teams.
  • Demonstrated expertise in FDA 21 CFR Part 820, ISO 13485, and applicable global medical device regulatory requirements.
  • Proven success leading process improvement initiatives, supported by Lean Six Sigma methodologies and certifications (Green or Black Belt preferred).
  • Strong technical background in process validation (IQ/OQ/PQ), statistical process control (SPC), and data driven manufacturing decision making .
  • Experience across complex manufacturing processes (e.g., injection molding, assembly, sterilization, packaging, automation, and/or cleanroom operations), with strong communication , project management, and cros s -f unctional collaboration skills.
  • Ability to travel 60 -70% travel if remote work arrangement, 40-50% if on-site/hybrid
  • Must have a valid driver’s license with an acceptable driving record

Nice To Haves

  • Master’s degree or MBA preferred.
  • Proven success leading process improvement initiatives, supported by Lean Six Sigma methodologies and certifications (Green or Black Belt preferred).

Responsibilities

  • Lead, mentor, and develop a high ‑ performing Process Engineering team, fostering a culture of continuous improvement, accountability, and technical excellence.
  • Define and execute process engineering strategies aligned with business objectives, including production efficiency, cost reduction, quality improvement, and new product introduction (NPI).
  • Oversee the design, development, and optimization of scalable, cost ‑ effective manufacturing processes for new and existing medical device products using Lean and Six Sigma methodologies.
  • Oversee the design, development, and optimization of scalable, cost ‑ effective manufacturing processes for new and existing medical device products using Lean and Six Sigma methodologies.
  • Manage departmental budgets, resources, and project prioritization to ensure effective execution of strategic and operational goals.
  • 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
  • Collaborate cross ‑ functionally with R&D, Quality, Operations, Supply Chain, and Regulatory teams to support technology adoption, equipment implementation, and successful product transfers.

Benefits

  • Beckman Coulter Diagnostics , a Danaher operating company, offers 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 .
  • 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.
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