Terumo Medical Corporation · 1 day ago
Principal Engineer, Automation and Controls
Elkton, MD
Full-time
Onsite
Senior Level, Lead/Staff
$141K/yr - $193K/yr
15+ years expTerumo Medical Corporation is seeking a Principal Engineer – Automation and Controls who will be responsible for advancing complex technical projects in the realm of Process Controls, Automated Systems, and Operational Technology. The role involves providing strategic inputs and technical expertise to support a portfolio of projects, overseeing the Automated System Lifecycle, and ensuring compliance with regulatory standards while leading initiatives for new product and process development.
HardwareHealth CareHealth DiagnosticsIndustrial ManufacturingManufacturingMedicalMedical Device
Hiring Manager
Julia Campbell
Responsibilities
Lead the design, development, and qualification of products, processes, and control systems in compliance with TMC Quality System requirements and regulatory standards
Provide strategic guidance and technical support in management and executive meetings, contributing to department strategies and initiatives
Provide technical direction, insight, and coaching to project leaders in solving complex product/process design, development, and production issues
Ensure all automation and control systems comply with FDA regulations, ISO standards, GMP requirements specific to medical devices and all national regulations
Offer insights and guidance on process control systems for designing automated solutions for new or modified production processes
Serve as the Subject Matter Expert for Process Controls, Automated Systems, and OT in new product introduction processes
Lead the design, development, programming, testing, and implementation of new or novel control system designs and automated production processes
Develop complex technical strategies for projects involving new smart technologies for product/process improvement
Design, develop, commission, and validate processes, ensuring the integration of innovative technologies
Develop and implement Process Controls and Automation design standards incorporating new industry technologies to advance manufacturing infrastructure
Lead broad process improvement initiatives to enhance team efficiency and functionality
Participate in design reviews, project planning activities, and formal project reviews
Prepare and present technical presentations to various levels of personnel, ensuring clear communication of technical activities
Efficiently manage resources, including time, budget, and personnel, to ensure successful project completion
Foster effective working relationships with senior engineers and leaders in Project Management Office (PMO), Product Development, Operations Engineering, Quality, and Manufacturing
Attend business meetings, prepare minutes, communications, and reports, ensuring effective stakeholder communication
Work collaboratively with cross-functional teams, including engineers, quality assurance, and production staff, to ensure seamless integration of automation solutions
Perform other job-related duties when assigned
Qualification
Required
Extensive experience in developing automated manufacturing processes for medical devices or other regulated industries
Expertise in industry standards and systems, including electrical codes, PLCs, HMI, SCADA, DCS, industrial robots, motion control systems, sensors, actuators, vision systems, data historians, MES, IoT, Industry 4.0, cybersecurity, and data integrity for OT systems
Exceptional ability to learn new technologies and explain complex engineering problems to non-engineering personnel
Proficiency in creating and delivering presentations to executive management and preparing detailed technical reports for regulatory bodies like the FDA
Strong troubleshooting skills for equipment and instrument issues
Effective use of MS Office Suite and CAD software for electrical and mechanical design
BS in Electrical Engineering, Mechanical Engineering, Computer Engineering, or related technical field, or equivalent experience
15+ years in process control system design, automation, and integration within research and manufacturing environments in the medical field
Preferred
Certified Automation Professional (CAP)
Lean & Six Sigma Black Belt (SSBB)
Benefits
Paid vacation
Paid holidays
Health, dental and vision benefits
401(k), with matching contributions
Tax advantage savings accounts
Legal plan
Voluntary life and AD&D insurance
Voluntary long-term disability
Short term disability
Critical illness and accident insurance
Parental leave
Personal leave
Tuition reimbursement
Travel assistance
Employee assistance program
Company
Terumo Medical Corporation
Our Promise At Terumo, everything starts with our unwavering commitment to patients.
1001-5000 employees
H1B Sponsorship
Terumo Medical 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
2024 (5)
2023 (2)
2022 (2)
2021 (4)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Shahnawaz Khan
CTO & Head of IT
Michael J M.
Sr. VP, Medcal Affairs, Chief Medical Officer
Recent News
Orchestra BioMed Holdings, Inc.
2025-10-28
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