Manager, Software Systems Engineering

Requisition ID: 33426

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.

Manager, Software Systems Engineering

JOB SUMMARY

This role leads one of our Software Systems Engineering teams responsible for driving excellence across our medical device software portfolio. You'll combine strategic leadership with technical expertise to optimize software development processes, ensure regulatory compliance, and cultivate high-performing teams. The ideal candidate brings deep expertise in modern systems engineering methodologies, requirements excellence, and risk management for medical device software. You'll independently develop objectives and global strategies to achieve business goals, drive quality across the product lifecycle, and devise solutions for complex problems with broad company impact.

ESSENTIAL DUTIES

• Lead and mentor a global Software Systems Engineering team, fostering technical excellence, continuous improvement, and professional development.
• Define and implement product strategies aligned with business goals and regulatory requirements across concurrent product releases.
• Optimize resource allocation, workload management, and long-term capacity planning to ensure successful delivery across multiple projects.
• Drive systems engineering principles within the team and across functions to enhance medical device software development.
• Make informed, data-driven decisions in a fast-paced environment, analyzing complex issues and balancing short-term needs with long-term goals.
• Collaborate cross-functionally to integrate best engineering practices throughout the software development lifecycle.
• Build strong relationships across teams to identify issues early and drive effective system-wide solutions.
• Contribute to strategic planning to set technical objectives for projects and engineering groups.
• Apply technical expertise to evaluate and improve global products and solutions from conception to implementation, ensuring alignment with product and architectural roadmaps.
• Drive safety and cybersecurity risk management process improvements for medical device software.
• Establish and maintain quality management systems ensuring compliance with FDA, ISO, and global regulatory standards.
• Support quality governance activities including audits, submissions, regulatory inspections, and effectiveness reviews.

MINIMUM QUALIFICATION REQUIREMENTS

Education

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

Experience

• Minimum 10 years of experience in related function.
• Minimum 5 years in a supervisory capacity preferred.
• Demonstrated leadership and success delivering large complex projects across the entire lifecycle.
• Experience in both systems engineering and software engineering preferred.

Skills

• A change leader who identifies opportunities for improvement and drives innovative solutions.
• Experience in regulated environments with ability to interpret and apply industry standards to software development.
• Extensive experience defining and documenting system and software requirements adhering to ISO/IEC/IEEE 29148:2018 standards.
• Expertise in developing medical device software compliant with IEC 62304:2006/AMD 1:2015 or similar standards.
• Proficient in risk management processes, including FMEA, and knowledge of ISO 14971:2019 for medical device risk management.
• Demonstrate sound judgment in decision-making, balancing commercial needs with development requirements.
• Ability to influence and lead diverse teams across multiple disciplines and projects simultaneously.
• Track record of implementing process improvements to enhance efficiency and quality supporting timely delivery.
• Advanced understanding of Design Controls and Quality Management Systems in product development.
• Proven management expertise in planning, budgeting, resource allocation, and workload management across multiple projects to meet business goals.
• Strong communication skills with ability to influence cross-functional teams and senior leadership.
• Ability to balance immediate product needs with long-term technology strategy and company vision.

-Or-

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

PHYSICAL REQUIREMENTS

Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

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:$119,500.00to$149,400.00 -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:15.0%

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.