Terumo Blood and Cell Technologies
Engineer 3 - Product Configuration Mgmt
Terumo Blood and Cell Technologies, Lakewood, Colorado, United States
Requisition ID:
34082 At Terumo Blood and Cell Technologies, our 7,000+ global associates are 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 used to collect, separate, manufacture, and process various components of blood and cells. With our innovative technologies and services, we touch a patient’s life every second of every day and are committed to increasing the number of patients we serve.
Advancing healthcare with heart. With some of the best 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 focused on making a difference.
Join us and help shape our future. You create your future and ours. JOB TITLE: Engineer Level 3 JOB SUMMARY We are seeking a Product Configuration Management Systems Engineer to 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 product lifecycle. The ideal candidate will apply the principles of EIA-649C and the GEIA-HB-649A Implementation Guide to ensure traceability, integrity, and control of product configurations in a regulated environment. ESSENTIAL DUTIES Architect and implement a comprehensive product configuration management strategy aligned with EIA-649C principles. Design, implement, and maintain a robust CM strategy for complex medical device systems. Define and enforce rulesets to ensure CM best practices across 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 attributes, relationships, dependencies, versions, and releases. Support concurrent development paths, ensuring baseline integrity and traceability across multiple 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 deployment to ensure Codebeamer and its CM mechanisms meet requirements. OTHER DUTIES AND RESPONSIBILITIES Design and implement PTC Codebeamer ALM tool enhancements and updates sustainably. Configure PTC Codebeamer, including projects, tracker types, object types, fields, parameters, traceability, document management, reporting, roles, permissions, workflows. Implement integrations with engineering applications such as JIRA, Windchill, and Git/GitHub via Open API. MINIMUM QUALIFICATIONS Education Bachelor’s degree or equivalent experience; a Bachelor of Science in Engineering is preferred. Experience Minimum 4 years of relevant experience. At least 2 years of GMP manufacturing experience required. Skills Strong communication, cross-functional collaboration, mentoring, technical leadership, project management, and teamwork skills. Experience managing product variants and concurrent releases throughout the development lifecycle. Experience establishing and maintaining baselines for traceability and configuration control. Experience with requirement and test management tools (e.g., DOORS, Jama, HP ALM, Windchill RV&S, PTC Codebeamer). Preferred: familiarity with ISO 13485, 21 CFR Part 11, GxP, INCOSE CSEP, SysML, and tools like CATIA Magic, PTC Modeler, or Enterprise Architect. Preferred: programming experience (Java, JavaScript, XML, HTML, .NET) and REST API integration. Preferred: understanding of EIA-649C CM functions, FDA regulations, IEC 62304, ISO 14971, ISO/IEC/IEEE standards. Excellent analytical, communication, and problem-solving skills, with effective verbal and written communication. - Or equivalent competency level through experience and education. PHYSICAL REQUIREMENTS Includes use of PPE, reading, speaking, hearing, walking, bending, standing, reaching, dexterity, and occasional lifting up to 50 pounds or transporting up to 500 pounds. Reasonable accommodations can be made for individuals with disabilities. Additional Physical Requirements Travel may be required based on business needs. Target Pay Range:
$105,800 - $132,300, determined by education, experience, skills, and market factors. Target Bonus:
7.0% We offer comprehensive benefits including medical, dental, vision, wellness programs, life and disability insurance, voluntary programs, 401(k) matching, and paid time off. Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921, headquartered in Tokyo, Japan, with a global presence serving over 130 countries. Our core values are Respect, Integrity, Care, Quality, and Creativity. We are committed to diversity and inclusion and provide a safe, drug-free workplace.
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34082 At Terumo Blood and Cell Technologies, our 7,000+ global associates are 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 used to collect, separate, manufacture, and process various components of blood and cells. With our innovative technologies and services, we touch a patient’s life every second of every day and are committed to increasing the number of patients we serve.
Advancing healthcare with heart. With some of the best 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 focused on making a difference.
Join us and help shape our future. You create your future and ours. JOB TITLE: Engineer Level 3 JOB SUMMARY We are seeking a Product Configuration Management Systems Engineer to 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 product lifecycle. The ideal candidate will apply the principles of EIA-649C and the GEIA-HB-649A Implementation Guide to ensure traceability, integrity, and control of product configurations in a regulated environment. ESSENTIAL DUTIES Architect and implement a comprehensive product configuration management strategy aligned with EIA-649C principles. Design, implement, and maintain a robust CM strategy for complex medical device systems. Define and enforce rulesets to ensure CM best practices across 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 attributes, relationships, dependencies, versions, and releases. Support concurrent development paths, ensuring baseline integrity and traceability across multiple 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 deployment to ensure Codebeamer and its CM mechanisms meet requirements. OTHER DUTIES AND RESPONSIBILITIES Design and implement PTC Codebeamer ALM tool enhancements and updates sustainably. Configure PTC Codebeamer, including projects, tracker types, object types, fields, parameters, traceability, document management, reporting, roles, permissions, workflows. Implement integrations with engineering applications such as JIRA, Windchill, and Git/GitHub via Open API. MINIMUM QUALIFICATIONS Education Bachelor’s degree or equivalent experience; a Bachelor of Science in Engineering is preferred. Experience Minimum 4 years of relevant experience. At least 2 years of GMP manufacturing experience required. Skills Strong communication, cross-functional collaboration, mentoring, technical leadership, project management, and teamwork skills. Experience managing product variants and concurrent releases throughout the development lifecycle. Experience establishing and maintaining baselines for traceability and configuration control. Experience with requirement and test management tools (e.g., DOORS, Jama, HP ALM, Windchill RV&S, PTC Codebeamer). Preferred: familiarity with ISO 13485, 21 CFR Part 11, GxP, INCOSE CSEP, SysML, and tools like CATIA Magic, PTC Modeler, or Enterprise Architect. Preferred: programming experience (Java, JavaScript, XML, HTML, .NET) and REST API integration. Preferred: understanding of EIA-649C CM functions, FDA regulations, IEC 62304, ISO 14971, ISO/IEC/IEEE standards. Excellent analytical, communication, and problem-solving skills, with effective verbal and written communication. - Or equivalent competency level through experience and education. PHYSICAL REQUIREMENTS Includes use of PPE, reading, speaking, hearing, walking, bending, standing, reaching, dexterity, and occasional lifting up to 50 pounds or transporting up to 500 pounds. Reasonable accommodations can be made for individuals with disabilities. Additional Physical Requirements Travel may be required based on business needs. Target Pay Range:
$105,800 - $132,300, determined by education, experience, skills, and market factors. Target Bonus:
7.0% We offer comprehensive benefits including medical, dental, vision, wellness programs, life and disability insurance, voluntary programs, 401(k) matching, and paid time off. Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921, headquartered in Tokyo, Japan, with a global presence serving over 130 countries. Our core values are Respect, Integrity, Care, Quality, and Creativity. We are committed to diversity and inclusion and provide a safe, drug-free workplace.
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