Engineer 3 - Product Configuration Mgmt

Requisition ID: 34082

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.

JOB TITLE: Engineer Level 3

JOB SUMMARY

We are seeking a Product Configuration Management Systems Engineerto lead the design, implementation, and maintenance of a robust configuration management (CM) strategy for complex medical device systems. This includes software, hardware, disposables, labeling, and integrated systems across the entire product lifecycle. The ideal candidate will apply the principles ofEIA-649Cand theGEIA-HB-649A Implementation Guideto ensure traceability, integrity, and control of product configurations in a regulated environment.

ESSENTIAL DUTIES

• Architect and implementa comprehensive product configuration management strategy aligned with EIA-649C principles.
• Apply the design, implementation, and maintenance of a robust configuration management (CM) strategy for complex medical device systems.
• Define and enforce rulesetsto ensure CM best practices across all R&D disciplines and product lines.
• Configure and maintain the PTC Codebeamer ALM platform to support multi-project, multi-variant development environments and product configurations.
• Manage configuration items, including their attributes, relationships, dependencies, versions, and releases.
• Support concurrent development paths, ensuring baseline integrity and traceability across multiple fielded versions.
• Collaborate with cross-functional teams (Systems Engineering, Design Quality, Regulatory) to align CM with business and functional requirements.
• Train and support users, develop documentation, and validate tool configurations and data integrity.
• Continuously improve CM workflows, tool integrations, and reporting capabilities to support design controls and compliance.
• Perform system testing and deploymentto ensure Codebeamer and its CM mechanism meets business and regulatory requirements.

OTHER DUTIES AND RESPONSIBILITIES

• Design and implement PTC Codebeamer ALM tool enhancements and updates in a sustainable and maintainable manner.
• Configure PTC Codebeamer, including the creation and modification of projects, tracker types, object types, fields, parameter values, traceability relationships, document/change/release management, reporting, roles and permissions, workflows.
• Implement PTC Codebeamer integrations with engineering applications such as JIRA, Windchill, and Git / GitHub via Open API.

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 4 years experience.
• Two years of GMP manufacturing experience required.

Skills

• Stronginteractive skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team members, team behavior, and support for junior engineers, technicians, and management.
• Ability to manage product variants and concurrent releases across the full development lifecycle.
• Experienced in establishing and maintaining baselines to ensure traceability, consistency, and effective configuration control.
• Experience withrequirement and test management tools(e.g., DOORS, Jama, HP ALM, Windchill RV&S, PTC Codebeamer).
• Preferred: Familiarity withISO 13485, 21 CFR Part 11, and GxP.
• Preferred: Knowledge of or certification in INCOSE CSEP.
• Preferred: Knowledge ofSysMLand tools like CATIA Magic, PTC Modeler, or Enterprise Architect.
• Preferred: Programming experience (Java, JavaScript, XML, HTML, .NET) and REST API integration.
• Preferred: Understanding ofEIA-649C CM functions: Planning & Management, Identification, Change Management, Status Accounting, and Verification & Audit.
• Preferred: Working knowledge of key regulatory and industry standards, including FDA regulations, IEC 62304 (medical device software lifecycle processes), ISO 14971 (risk management for medical devices), ISO/IEC/IEEE 15288 (system life cycle processes), and ISO/IEC/IEEE 29148 (requirements engineering).
• Excellent analytical, communication, and problem-solving skills. 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 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

Requires travel based on business needs.

Target Pay Range:$105,800.00to$132,300.00 -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%

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.