Engineer 3 - Pump Systems

Requisition ID: 33339

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.

Engineer 3 - Pump Systems

JOB SUMMARY

Systems engineer translates the user needs and business needs into the specifications that drive design, implementation, testing of products that are used for collection of blood and blood components, with a special focus on pump systems. Systems engineer will practice design controls in compliance with the quality management systems to deliver products that are effective, safe and compliant. System engineer will coordinate pump system design activities in collaboration with various stakeholders including mechanical, electrical, software, disposables, quality, manufacturing and commercial Teams. Systems engineer will independently conduct design change impact assessment, coordinate technical reviews of the changes, conduct failure analysis and potential risk impact assessment as part of a cross-functional Team.

ESSENTIAL DUTIES

• Translate user and business requirements into detailed product requirement specifications and design specifications for pump systems.
• Use systems thinking to troubleshoot and design complex platforms integrating equipment, software, and disposables, achieving functional and reliability specifications.
• Characterize, design, analyze, and optimize complete pump systems, considering all aspects such as pump selection, tubing layout, software requirements, controls, energy efficiency, and system reliability, to ensure optimal and accurate fluid transfer.
• Define integration and verification plans, defining adequate resources and time for execution of the plans.
• Generate and evaluate alternative solution concepts and document subsystem architectures for pump systems.
• Define and manage project scope to optimize resources and avoid scope creep.
• Independently conduct technical reviews with stakeholders to meet project design objectives.
• Highlightrisks and understand how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.
• Develop and approve test protocols to perform functional testing and maximize reuse for multiple configurations.
• Lead design changes to implement and enhance features for pump systems in blood collection platforms, ensuring quality and regulatory compliance.
• Support design transfer to enable successful commercialization of complex products.
• Create, maintain and release artifacts in Design History File (DHF), Device History Record (DHR), Device Master Record (DMR).
• Lead defect management meetings to achieve actionable outcomes and maintain good documentation practices.
• Perform failure analyses to prioritize testing and ensure design completeness and product quality.
• Follow technical specification requirements and provide feedback on pump system technical processes and procedures.

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 4 years experience.
• Two years of GMP manufacturing experience required.
• Minimum 2 years experience with pump systems, testing, and requirements definition

Skills

• Requires demonstrated skills in technical innovation and technical leadership in pump system functionality and fluid dynamics.
• Experience in conducting risk analysis for defects to demonstrate the safety and efficacy of medical devices with pump systems
• Knowledgeable in evaluating designs for serviceability and manufacturability.
• Strong skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, project management, coordination with cross-functional team member, team behavior, and support for junior engineers, technicians, and management.
• Strong technical problem solving skills.
• Mechanical and electronic ability aptitude to assist with equipment troubleshooting.
• Understanding of and adherence to GMP practices and regulations, such as ISO 13485, ISO 14971, IEC 62304, IEC 62366, and IEC 60601 for medical device development.
• Knowledgeand ability toimplement FDA or 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 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:$107,000.00to$133,800.00 -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:10.0%

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.