Beckman Coulter Diagnostics · 13 hours ago
Sr. Manager, Global Process Engineering
Chaska, MN
Full-time
Hybrid
Senior Level, Lead/Staff
$160K/yr - $190K/yr
10+ years expBeckman Coulter Diagnostics is a global leader in clinical diagnostics, dedicated to innovating for tangible impact in life sciences, diagnostics, and biotechnology. The Sr. Manager, Global Process Engineering is responsible for leading and shaping manufacturing capabilities, ensuring quality and efficiency in medical device production while overseeing a team of engineers in process development and optimization.
BiotechnologyHealth DiagnosticsLife ScienceManufacturing
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
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
Qualification
Required
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
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)
Strong communication, project management, and cross-functional 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
Preferred
Master's degree or MBA
Lean Six Sigma methodologies and certifications (Green or Black Belt preferred)
Benefits
Paid time off
Medical/dental/vision insurance
401(k)
Company
Beckman Coulter Diagnostics
A global leader in advanced diagnostics, Beckman Coulter has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 80 years.
10001+ employees
H1B Sponsorship
Beckman Coulter Diagnostics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (34)
2024 (27)
2023 (27)
2022 (38)
2021 (26)
2020 (32)
Funding
Current Stage
Late StageTotal Funding
unknown2011-02-07Acquired
Leadership Team
Ruth Lyons
VP North America Marketing
Recent News
2025-12-18
2025-12-17
Company data provided by crunchbase