Engineer 2 - Systems Engineering

Requisition ID: 35079

At Terumo Blood and Cell Technologies, our 8,000+ 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.

Systems Engineer Level 2

JOB SUMMARY

Performs duties that require application of intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields. Assesses impact of design changes on product functionality/quality. Evaluates and develops plans, requirements, and associated criteria for a variety of products, and design activities. Carries out complex or novel research assignments requiring the development of new or improved systems engineering techniques and procedures.

This position represents the function of Systems Engineer as a team member on development projects. The Systems Engineer develops, performs, reviews, and approves work required to deliver quality product designs per customer and business expectations following the design controls process. Participates and contributes to regulatory submissions and audits across a global customer base. Understands, provides direction, and adheres to Design Controls procedures. Ensures customer and regulatory requirements are upheld in accordance with business needs.

ESSENTIAL DUTIES

• Leads, contributes to, and is accountable for new and/or updated product design projects.
• Performs, and supports design controls activities and deliverables.
• Guides the successful completion of design control deliverables for major programs and may function in a project leadership role.
• Directs one or more major phases of complex engineering work, utilizing engineering skills to devise efficient approaches to design and other problems encountered in projects.
• Develops, and/or tests new design processes/tools that have a significant impact on multiple disciplines.
• Contributes to the establishment of business objectives, goals, budgets and costs as requested.
• Presents complex technical information/analysis, and responds to questions from technical staff members and management regularly and effectively.
• Provides broad-based direction for colleagues within functional area and cross functionally.
• Applies technical expertise to complex tasks with in-depth knowledge of related work areas.
• Displays accessibility and sought out for consultation on a broad range of complex technical and industry issues.
• Works on complex issues where analysis requires an in-depth evaluation of variable factors.
• Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.

OTHER DUTIES AND RESPONSIBILITIES

• Work direction responsibility may include technicians and junior engineers.

• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

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 of Science Degree in Engineering, preferred.

Experience

• Minimum 2 years experience
• Medical device product development experience preferred
• Systems Engineering (in-depth understanding of how hardware, software, and disposables interact in a systematic way) preferred
• Customer interaction experience preferred

Skills

• Requires demonstrated skills in technical innovation, technical leadership, mechanical and or chemical engineering, fluids engineering, and cellular biology.
• Stronginteractive skills in general communication, 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.
• Strong technical problem solving skills.
• Understanding of and adherence to GMP practices and FDA regulations.
• Knowledgeand ability toimplement FDA and other regulatory requirements as necessary.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Knowledge and use of relevant PC software applications and skills to use them effectively.

-Or-

An equivalent competency level acquired through a variety 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

Requires travel based on business needs

Target Pay Range:$86,400.00to$108,000.00 -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:7.0%

We anticipate this requisition will be open for a minimum of five days, from . We encourage your prompt application.

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 2024, Terumo Blood and Cell Technologies reached $1.5 billion in revenue.
• We employ nearly 8,000 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 $2.4 million USD since 2025.

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.