Engineer 5 - Model Based Systems Engineering

Requisition ID:  32680  

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.

Engineer 5 – Model Based Systems Engineering

JOB SUMMARY

Responsible for strategic implementation and adoption of MBSE (Model Based Systems Engineering) across the organization, fostering a culture of innovation, efficiency, and traceability throughout the product development lifecycle. Develop and execute a comprehensive MBSE roadmap, including the selection and integration of advanced modeling tools, processes, and best practices.

ESSENTIAL DUTIES

• Champion the strategic implementation of MBSE (Model Based Systems Engineering) across the organization, fostering a culture of innovation, efficiency, and traceability throughout the product development lifecycle.
• Develop and execute a comprehensive MBSE roadmap, including the selection and integration of advanced modeling tools, processes, and best practices.
• Lead the upskilling and training of system engineering teams, empowering them to leverage MBSE methodologies effectively, and fostering a culture of continuous learning and improvement.
• Collaborate closely with cross-functional stakeholders, translating complex system requirements into comprehensive architecture designs and ensuring alignment with regulatory standards and industry best practices.
• Drive the optimization of clinical workflows and user experiences, leveraging human-centric design principles and data analytics to enhance product usability, safety, and diagnostic capabilities.
• Manage the end-to-end product development lifecycle, from concept ideation to commercialization, ensuring timely and cost-effective delivery of projects while maintaining the highest quality standards.
• Foster an environment of innovation, creativity, and intellectual curiosity, encouraging your team to explore novel approaches and push the boundaries of what's possible in medical device and disposables engineering.
• Serve as a thought leader and subject matter expert, representing the system engineering function at executive levels and industry forums, and contributing to the advancement of MBSE best practices.
• Anticipates problems, generates technically advanced alternatives and implements innovative solutions for complex problems which require the regular use of ingenuity and creativity.
• Understands the impact process change in one area will have on other areas and manages the impact of changes.
• Identifies risks and understands how to approach and complete multiple tasks/projects, avoiding major delays in schedules and product introduction or eventual loss of business. 

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor’s of Science degree or may have a Master of Science degree, in Engineering, preferred.

Experience

• Minimum 15 years experience.
• 15+ years of progressive experience.
• 5+ years experience with Design Controls.

Skills

• Proven expertise in implementing and deploying Model-Based System Engineering methodologies, processes, and tools.
• Comprehensive understanding of medical device regulations, quality systems, and compliance requirements (e.g., 21 CFR 820, ISO 14971, ISO 13485, IEC 62304, IEC 60601, IEC 62366).
• Exceptional leadership skills, with the ability to inspire, mentor, and develop high-performing teams.
• Strong project management skills, with experience managing complex projects, budgets, and resource allocation.
• Excellent communication and stakeholder management skills, with the ability to articulate technical concepts to diverse audiences effectively.
• Proven track record of driving innovation, continuous improvement, and delivering transformative solutions in the medical device or healthcare technology industry.
• Demonstrated interactive skills in cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team member, team behavior, and support for subordinates, junior engineers, technicians, and management.
• Regularly and effectively presents complex technical information, analysis, and responds to questions from technical staff members and management.
• Demonstrated ability to communicate effectively both verbally and in writing.

-Or-

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

PHYSICAL REQUIREMENTS

General Labor Environment requirements include use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Additional Physical Requirements

Domestic and International travel may be required.

Target Pay Range:  $150,200.00 to $187,700.00  -  Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base:  20.0%

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

• Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
• In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
• We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
• We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
• Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
  • Respect – Appreciative of others
  • Integrity – Guided by our mission
  • Care – Empathetic to patients
  • Quality – Committed to excellence
  • Creativity – Striving for innovation
• We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

We are proud to be an Equal Opportunity Affirmative Action Employer.  All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.