Principal Engineer, Automation & Controls

Principal Engineer, Automation & Controls Location: Elkton, MD, US Company: Terumo Medical Corporation Department: PM&PD Management Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world‑class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo‑based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come. At Terumo we believe in the power of personal growth and will encourage you to get in the driver’s seat—progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what’s next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real‑world, impactful solutions for patients. Join us and help shape wherever we go next! Advancing healthcare with heart Job Summary The Principal Engineer – Automation and Controls is a highly experienced expert role responsible for advancing complex technical projects independently or as part of a team. This position involves providing strategic inputs and technical expertise to support a portfolio of projects, focusing on Process Controls, Automated Systems, and Operational Technology (OT). The Principal Engineer will oversee the Automated System Lifecycle definition, design, development, integration, and validation of new or modified manufacturing processes from concept through commercialization, ensuring smooth product launch and transfer into the manufacturing Value Streams. In addition to the above, the Principal Engineer – Automation and Controls Engineering position is accountable for providing sound technical leadership to new product and process development activities by providing technical direction, insight and coaching to project technical leaders and process leaders in solving complex product/process design, development, and production issues. The Principal Engineer – Automation and Controls Engineering is expected to participate in solving the most complex technical and development issues requiring resolution. Depending on the department, the Principal Engineer may have direct reports with managerial responsibilities or will oversee project teams with overall responsibilities for complex projects. Responsibilities Technical Leadership 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. Automation Solutions 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. Process Improvement 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. Project Planning and Execution 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. Cross-Functional Collaboration 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. Working Conditions/Physical Requirements This position will be located in the Terumo facility located in Elkton, MD. The position will perform required duties in an office environment, the Product Development Laboratory and Process Pilot area, and within manufacturing areas. Access to hospitals and hospital operating rooms might be required to meet with clinicians and observe relevant clinical procedures associated with new product development activities. Knowledge, Skills and Abilities (KSA) Technical Leadership 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. Communication Skills 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. Problem‑Solving Skills Strong troubleshooting skills for equipment and instrument issues. Effective use of MS Office Suite and CAD software for electrical and mechanical design. Qualifications / Background Experiences Education: BS in Electrical Engineering, Mechanical Engineering, Computer Engineering, or related technical field, or equivalent experience. Experience: 15+ years in process control system design, automation, and integration within research and manufacturing environments in the medical field. Certifications: Certified Automation Professional (CAP) and Lean & Six Sigma Black Belt (SSBB) are desirable. It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, 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, and an employee assistance program. Pay range is $141,000 - $205,000. #J-18808-Ljbffr Terumo Cardiovascular Group