Terumo Blood and Cell Technologies · 1 day ago
Global Quality Digital Operations - Engineer 4 - SAP S4 Hana
Lakewood, CO
Full-time
Onsite
Senior Level, Lead/Staff
$126K/yr - $157K/yr
8+ years expTerumo Blood and Cell Technologies is a global leader in medical devices and related products, dedicated to improving patient lives. The Engineer Level 4 – SAP S/4HANA Quality Engineer will drive the Quality workstream of the S/4HANA transformation, leading strategic initiatives involving SAP configuration and ensuring compliance with global regulations.
Medical Device
Responsibilities
Lead the setup, customization, and continuous improvement of SAP S/4HANA modules such as Quality Management, Master Data Governance, Batch Release, Materials Management, Production Planning, and Document Management System to support Quality operations
Ensure SAP processes and documentation align with FDA, ISO 13485, and other global medical device regulations
Maintain high standards of data accuracy, traceability, and security within SAP systems, supporting audit readiness and regulatory inspections
Manage engineering change workflows and technical documentation within SAP, ensuring consistency and traceability across departments
Partner with Process Engineering, Finance, Regulatory, and Operations teams to align SAP capabilities with business needs and technical requirements
Lead SAP S/4 transformation, module update rollouts, and process redesigns. Provide technical direction and mentorship to junior staff
Apply Quality engineering principles to enhance SAP workflows that support design, validation, and manufacturing processes
Provide training and ongoing support to SAP users across departments. Develop best practice guides and troubleshoot system issues
Identify and implement improvements to SAP workflows that enhance efficiency, compliance, and user experience
Collaborate on dashboards and reports to monitor system performance, data quality, and operational metrics
Provide work direction to technicians and junior engineers
Collaborate with manufacturing and regulatory teams on compliance and operational issues
May contribute to business planning, budgeting, and strategic goal setting
Qualification
Required
Bachelor's degree in Engineering, Computer Science, or related field required
Minimum 8 years of engineering or ERP systems experience
5+ years of SAP experience, including full-cycle S/4HANA implementations
SAP S/4HANA Expertise: Advanced knowledge of SAP modules including MM, PP, QM, and DMS
Ability and willingness to manage multiple workstreams simultaneously and prioritize effectively across multi-site, global rollouts and legacy system integrations
Regulatory Knowledge: Familiarity with medical device regulations and their application within ERP systems
Technical Documentation: Skilled in managing engineering documentation and change control within SAP
Problem Solving: Ability to troubleshoot SAP-related issues and implement effective solutions
Collaboration: Experience working across departments to align SAP processes with business needs
Training & Mentorship: Capable of educating users and mentoring team members on SAP functionalities
Communication: Strong verbal and written communication skills; able to present complex technical information clearly
Must possess or be willing to acquire valid passport
International travel may be required
Position is on-site in Lakewood, Colorado
Preferred
Master's degree preferred
Familiarity with SAP related technologies (e.g., Activiate, Magnitude Angles) a plus
Benefits
Multiple group medical, dental and vision plans
A robust wellness program
Life insurance and disability coverages
Variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance
401(k) plan with a matching contribution
Vacation and sick time programs for associates
Company
Terumo Blood and Cell Technologies
Headquartered in Lakewood, Colorado, Terumo Blood and Cell Technologies is a global leader in blood component, therapeutic apheresis and cellular technologies serving customers in more than 150 countries.
5001-10000 employees
H1B Sponsorship
Terumo Blood and Cell Technologies 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 (14)
2024 (7)
2023 (8)
2022 (8)
2021 (8)
2020 (7)
Funding
Current Stage
Late StageLeadership Team
Antoinette Gawin
President & Chief Executive Officer at Terumo Blood and Cell Technologies
Rusty Spinney
Chief Financial Officer
Recent News
2024-04-09
biopharma-reporter.com
2023-12-22
Medical Device Network
2023-12-22
Company data provided by crunchbase