Sr. SW Systems Engineer

Requisition ID:  33134  

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.

Senior Software Systems Engineer

JOB SUMMARY

Responsible for software product definition and translation of  users’ needs, commercial desires, regulatory and technical standards into use cases, workflows, user stories, UI mockups, and software specifications for software development teams. This role is accountable for developing clear, concise software requirements for complex medical devices and their associated software applications. This role must understand the goals of the end user and develop in-depth product expertise, both from the user and technical perspectives. Working in a regulated industry, this role must adhere to design controls procedures and help teams to execute software development while generating evidence needed for regulatory submissions/audits. This role will work with cross-functional teams to make trade-off decisions between development effort, required functionality, and end user experience.

ESSENTIAL DUTIES

This role is responsible for the following as they relate to complex medical devices and their associated software applications:

• Develop clear, concise software requirements, behavior, and feature definition
• Participate in software planning and estimation
• Requirements allocation and traceability
• Software integration strategy and planning

Project:

• Lead complex programs consisting of several software development teams including global partner teams with limited oversight.
• Define software behavior (requirements, environment, performance, etc.) medical devices using a hybrid Waterfall-Scrum software development methodology, balancing structured planning with iterative development to meet project timelines while ensuring adherence to quality standards and customer requirements.
• Gather and prioritize scope inputs from diverse stakeholders including Business Area Leaders, Platform Tech Leads, Systems Engineering, Innovation, Software Development, Marketing, and Cybersecurity Teams. Define system behavior, use environment, requirements, feature definition, use case scenarios, full error paths, corner cases, and design constraints to ensure comprehensive project scope and functionality that meets customer needs.
• Collaborate effectively with multidisciplinary teams (systems engineering, software engineering, marketing, commercialization, regulatory affairs, quality assurance) to achieve customer requirements, design control objectives, and regulatory standards.
• Determine and enforce high level ordering of activities and feature sets to deliver project scope subsets to the software development teams.
• Obtain formal cross-functional agreement of scope and priority of each project scope subset prior to starting software design and development.
• Manage scope changes throughout the project lifecycle. For mid-project requirements changes, lead and conduct impact assessments on the requirements; requirement allocation; integration strategy; and project impacts. Participate in impact assessments on the requirements flow; verification strategy, plan or protocols; and existing design and development work.
• Collaborate with UI/UX designers, customer-facing associates, and human factors to create and optimize user interface design. Help drive consistency of product design and implementation across related platforms.
• Recognize opportunities to share or reuse design and implementation between platforms, leveraging common components to realize faster product development.
• Skilled in estimating project delivery dates through collaborative efforts with software development and verification teams, ensuring on-time delivery within budget.
• Work with software architects to define system behavior, allocate requirements, and review architectural design documentation.
• Collaborate with software architects to ensure functional and non-functional requirements are allocated to design elements and architecture.
• Owner of the interface control document which includes all interfaces with software, e.g., embedded to applications, software to hardware.
• Develop the integration test strategy and planning with input from software development to ensure all interfaces are successful. Ensure that integration points are satisfied before moving forward.
• Enforce project stage gates to ensure design controls adherence and best software lifecycle practices.
• Support junior software systems engineering associates on projects and project tasks.

Process:

• Interface and integrate with cross-functional teams (both non-R&D and R&D) to drive process improvements. Deliver content for meaningful, efficient, and consistent processes. Regularly identify potential improvements and contribution the organization strategy.
• Communicate effectively, collaborate well with others, maximize productivity, and align work with the organization's strategic goals.
• Deep end-to-end, hands-on knowledge of complex systems and their field applications including all system domains, i.e. hardware, software, disposables, labeling, embedded software, and interfacing software applications. Become a go-to person and system subject matter expert.

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor of Science degree in Computer science or Engineering or other science (e.g. chemistry, physics, biology).

Experience

Minimum 5 years of experience in developing medical device software compliant with IEC 62304:2006 / AMD 1:2015 Software life cycle processes for medical devices standard. Development of software to a similar standard or level of rigor also acceptable (e.g. aerospace).

Background in risk management processes, including FMEA (Failure Mode and Effects Analysis). Expertise in utilizing FMEA to analyze potential failure modes, prioritize risks, and develop robust mitigation strategies. Functional knowledge of ISO 14971:2019 Application of risk management to medical devices standard.

Experience in defining and documenting system and subsystem requirements for complex systems and software solutions. Proficient in adhering to ISO/IEC/IEEE 29148:2018 Systems and software engineering standard to ensure comprehensive and structured requirements engineering.

Expert in requirements traceability management tools to manage requirements and traceability between requirements, design elements, software test artifacts, interface controls, risk control measures, and outputs.

Demonstrated success delivering large complex projects across the entire lifecycle.

Skills

• Attention to Detail: Meticulous attention to detail in all tasks and projects.
• Collaboration and Team Contribution: Skilled in fostering open communication and collaboration, encouraging input from others and contributing to a positive team environment.
• Communication and Presentation: Clear communication and effective presentation skills, capable of delivering technical information to both technical and non-technical audiences and adept at responding to inquiries from various stakeholders.
• Critical Thinking: Apply critical thinking skills to analyze problems and develop innovative solutions.
• Decision-making and Problem Solving: Proficient in identifying and resolving issues promptly. Make timely decisions involving appropriate stakeholders, ensuring efficient problem resolution and project execution.
• Leading Teams: Demonstrated ability to lead teams towards achieving project milestones and goals.
• Listening and Observational Skills: Strong listening and observational skills, able to quickly grasp audience needs and adjust communication style accordingly.
• Organizational and Time Management: Excellent organizational and time management skills and proper prioritization, ensuring efficient workflow and deadlines consistently met.
• Ownership and Follow-through: Proactively pinpoint and take ownership of issues, including thorough follow-through to resolution.
• Regulatory and Technological Acumen: Proficient in navigating and managing challenges posed by rapidly evolving medical regulatory criteria and evolving software technologies, ensuring compliance and innovation.
• Resource Utilization: Skilled in identifying and leveraging resources effectively to optimize outcomes.
• Software Development Lifecycle: Extensive knowledge of the software development lifecycle (SDLC), from planning and development through to deployment and maintenance.
• Strategic Decision-making: Solve complex problems amidst significant ambiguity.
• Technical Recommendations: Capable of making and defending solid technical recommendations based on thorough analysis and understanding.
• Technology Proficiency: Knowledge and effective 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

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 occasional travel based on business needs.

Target Pay Range:  $103,200.00 to $129,000.00  -  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%

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.