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Senior Automation Engineer

2 months ago

Littleton, Colorado, United States Terumo BCT Full time

Requisition ID: 32506

At Terumo Blood and Cell Technologies, our dedicated team of over 7,000 global professionals is committed to improving patient outcomes worldwide. For Terumo, for Everyone, Everywhere.

We specialize in the design and production of medical devices and related products that facilitate the collection, separation, and processing of blood and cellular components. Our cutting-edge technologies and services positively impact patients' lives every moment of every day, and we are dedicated to expanding our reach. Advancing healthcare with heart.

With a talented workforce, a broad global presence, comprehensive benefits, and a unique organizational culture, Terumo Blood and Cell Technologies is an excellent environment for professional growth and collaboration aimed at making a meaningful difference. You shape your future and ours.

This senior engineering role entails providing technical guidance for the development and validation of automated manufacturing systems within a medical device context. The position requires leading both internal and external resources while mentoring junior engineers and technicians. Key responsibilities include:

  • Gathering and analyzing requirements from internal stakeholders.
  • Collaborating directly with machine integrators to ensure system performance aligns with customer specifications.
  • Documenting system requirements and overseeing machine assembly, acceptance testing, installation, debugging, and modifications of control software and data networks.
  • Conducting qualifications at site locations and offering post-validation production support.

KEY RESPONSIBILITIES

  • Design, installation, and validation of automated systems for medical device manufacturing in controlled environments.
  • Development and execution of commissioning protocols and reports.
  • Accountability for the delivery of comprehensive manufacturing systems from design inputs to design transfer.
  • Staying updated on the latest technologies and design practices to maintain industry relevance.
  • Conducting independent evaluations and making necessary adaptations to projects.
  • Leading major capital projects with total project leadership responsibilities.
  • Providing leadership and direction for the functional group's effectiveness while adhering to organizational policies.
  • Implementing and understanding regulatory requirements as necessary.
  • Identifying risks and efficiently completing tasks to avoid delays and resource expenditure.
  • Proactively advising team members on technical matters and fostering skill development.
  • Engaging with peers across projects to secure resources and commitments.
  • Managing frequent inter-organizational and external customer interactions, providing solutions to complex technical challenges.
  • Effectively presenting complex technical information and responding to inquiries from technical staff and management.
  • Collaborating effectively within a team environment to achieve common objectives.
  • Providing work direction to technicians and junior engineers.
  • Collaborating with manufacturing and other functional groups on compliance issues.

MINIMUM QUALIFICATIONS

Education

  • Bachelor's degree or equivalent experience in a relevant field.
  • Bachelor of Science in Engineering is preferred.

Experience

  • A minimum of 6 years in specifying, building, and qualifying manufacturing systems.
  • At least 2 years of experience in GMP manufacturing is required.
  • Experience in medical device or pharmaceutical manufacturing is preferred.

Skills

  • Demonstrated technical innovation and leadership in mechanical or electrical engineering.
  • Knowledge of machine control systems, including PLCs and HMIs.
  • Preferred experience with Allen-Bradley control systems and Cognex vision systems.
  • Ability to define process requirements based on customer feedback.
  • Strong communication and collaboration skills, with a focus on mentoring and technical leadership.
  • Proficient problem-solving abilities.
  • Mechanical and electronic troubleshooting skills.
  • Understanding of GMP practices and FDA regulations.
  • Effective verbal and written communication skills.
  • Proficient in relevant PC software applications.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

TRAVEL

Willingness to travel to domestic and international suppliers up to 25%.

PHYSICAL REQUIREMENTS

  • General labor environment requirements include the use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.

COMPENSATION

Target Pay Range: $107,000.00 to $133,000.00, determined by education, experience, knowledge, skills, and abilities.

Target Bonus on Base: 7.0%

At Terumo Blood and Cell Technologies, we offer competitive total reward offerings that include compensation, benefits, and recognition programs that support the well-being of our associates and their families.

  • Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
  • We employ nearly 7,000 associates globally, with a presence in over 130 countries.
  • Our core values guide our actions and support our mission of contributing to society through healthcare.

We are proud to be an Equal Opportunity Affirmative Action Employer, committed to providing a safe and secure working environment.