Principal Engineer, Automation & Controls

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.
 

Job Details/Responsibilities

1.

   Technical Leadership:
a.

   Lead the design, development, and qualification of products, processes, and control systems in compliance with TMC Quality System requirements and regulatory standards.
b.

   Provide strategic guidance and technical support in management and executive meetings, contributing to department strategies and initiatives.
c.

   Provide technical direction, insight, and coaching to project leaders in solving complex product/process design, development, and production issues.
d.

   Ensure all automation and control systems comply with FDA regulations, ISO standards, GMP requirements specific to medical devices and all national regulations.
2.

   Automation Solutions:
a.

   Offer insights and guidance on process control systems for designing automated solutions for new or modified production processes.
b.

   Serve as the Subject Matter Expert for Process Controls, Automated Systems, and OT in new product introduction processes.
c.

   Lead the design, development, programming, testing, and implementation of new or novel control system designs and automated production processes.
d.

   Develop complex technical strategies for projects involving new smart technologies for product/process improvement.
e.

   Design, develop, commission, and validate processes, ensuring the integration of innovative technologies.
3.

   Process Improvement:
a.

   Develop and implement Process Controls and Automation design standards incorporating new industry technologies to advance manufacturing infrastructure.
b.

   Lead broad process improvement initiatives to enhance team efficiency and functionality.
4.

   Project Planning and Execution:
a.

   Participate in design reviews, project planning activities, and formal project reviews.
b.

   Prepare and present technical presentations to various levels of personnel, ensuring clear communication of technical activities.
c.

   Efficiently manage resources, including time, budget, and personnel, to ensure successful project completion.
5.

   Cross-Functional Collaboration:
a.

   Foster effective working relationships with senior engineers and leaders in Project Management Office (PMO), Product Development, Operations Engineering, Quality, and Manufacturing.
b.

   Attend business meetings, prepare minutes, communications, and reports, ensuring effective stakeholder communication.
c.

   Work collaboratively with cross-functional teams, including engineers, quality assurance, and production staff, to ensure seamless integration of automation solutions.
6.

   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:
a.

   Extensive experience in developing automated manufacturing processes for medical devices or other regulated industries.
b.

   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.
2.

   Communication Skills:
a.

   Exceptional ability to learn new technologies and explain complex engineering problems to non-engineering personnel.
b.

   Proficiency in creating and delivering presentations to executive management and preparing detailed technical reports for regulatory bodies like the FDA.
3.

   Problem-Solving Skills:
a.

   Strong troubleshooting skills for equipment and instrument issues.
b.

   Effective use of MS Office Suite and CAD software for electrical and mechanical design.
 

Qualifications/ Background Experiences

1.

   Education: BS in Electrical Engineering, Mechanical Engineering, Computer Engineering, or related technical field, or equivalent experience.
2.

   Experience: 15+ years in process control system design, automation, and integration within research and manufacturing environments in the medical field.
3.

   Certifications: Certified Automation Professional (CAP) and Lean & Six Sigma Black Belt (SSBB) are desirable.