Principal Engineer, Automation & Controls
TIS Product Development & Lifecycle Mana
- Elkton, MD
- $141,300-194,200 per year
- Permanent
- Full-time
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 RequirementsThis 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 Experiences1. 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.Benefits / CompensationWe provide competitive and comprehensive benefit options that allow you to design your own plan based on your individual needs which include: 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. $141,300 - $194,200It 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.