Danaher Corporation · 16 hours ago
Sr. Manager, Global Process Engineering
USA - Chaska - Beckman Coulter, Inc. - BC18
Full-time
Hybrid
Senior Level, Lead/Staff
$160K/yr - $190K/yr
10+ years expBeckman Coulter Diagnostics, a part of Danaher Corporation, is a global leader in clinical diagnostics. The Sr. Manager, Global Process Engineering will lead a team in optimizing manufacturing processes for medical devices, ensuring quality and compliance while driving continuous improvement initiatives.
BiotechnologyHealth CareHealth DiagnosticsLife ScienceMedical
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 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)
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 certifications (Green or Black Belt preferred)
Benefits
Paid time off
Medical/dental/vision insurance
401(k)
Company
Danaher Corporation
Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health.
10001+ employees
H1B Sponsorship
Danaher Corporation 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 (7)
2024 (4)
2023 (3)
2022 (1)
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
unknown1979-01-05IPO
Leadership Team
Rainer Blair
President & CEO
Thomas Joyce
President & CEO
Recent News
2026-01-14
2026-01-13
2026-01-12
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