Academic Specialist | Ochoa Middle School

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 System which makes everything possible.

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. It will be a remote position, preferably near Chaska, Minnesota or near an airport for travel.

• Strategic Leadership & Management:
  Lead, mentor, and develop a high‑performing 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, cost‑effective manufacturing processes for new and existing medical device products using Lean and Six Sigma methodologies.
• Optimization:
  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.
• 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 cross‑functionally with R&D, Quality, Operations, Supply Chain, and Regulatory teams to support technology adoption, equipment implementation, and successful product transfers.

• Education:
  
  Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, Industrial, Manufacturing) or a closely related technical field;
  Master’s 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…