Engineer 4 - Design Quality

Requisition ID:  32772  

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.

The Design Quality Engineer (DQE) exhibits a robust understanding of engineering principles and practices, applied across various assignments and related fields, all within a collaborative team environment. The DQE will be at the forefront of representing design quality in our organization. This is a pivotal role in shaping quality plans and establishing criteria for diverse products and design activities. This position presents a unique opportunity to make a meaningful contribution to our mission of enhancing patient care through technological advancement. The role is part of an innovative team dedicated to pushing the boundaries of what is possible in medical technology.

ESSENTIAL DUTIES

• Quality Management and Compliance
  • Supporting the Global Quality Management System (QMS) by comprehending its requirements, escalating compliance concerns when needed, and ensuring adherence to regulatory standards.
  • Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.
  • Ensures completion of CAPA activities including facilitating root cause analysis and leading cross-functional teams for implementation.
  • Ensures compliance with global QMS procedures - design and development, inclusive of design change control.
  • Supports external QMS inspection and audit.
• Software Development Process
  • Demonstrate a strong grasp of both agile and waterfall methods of development.
  • Ensure alignment with project timelines and design controls deliverables within these frameworks and the compliance to regulations and objectives.
  • Assess and critique the thoroughness and effectiveness of project software testing methodologies.
• Device Support
  • Supporting physical devices focusing on quality for embedded software development and testing.
  • Ensures a comprehensive understanding of hardware and software interactions to identify potential system design failures.
  • Facilitates and manage risk management activities.
  • Actively participate in new product development and engages with cross functional partners in the development phases to develop strategies, risk management activities and verification and validation test strategies.
  • Propose enhancements to improve design requirements, design implementation traceability, testing accuracy and reliability.
  • Critically analyze whether the software is performing its intended functions correctly.
  • Ensures comprehensive identifying, documenting, and tracking software defects in devices.
• Design Quality Leadership
  • Conducting complex or novel research assignments that require the development of new or improved design quality techniques and procedures.
  • Employs an in-depth knowledge of cross-functional areas, applying knowledge to other technical domains.
  • Guides the successful completion of design quality deliverables for major programs; may function in a project leadership role.
  • Directs one or more major phases of complex engineering work, utilizing engineering skills to devise entirely new approaches to design quality problems encountered in projects.
  • Mentors less experienced engineers.
• Communication
  • Presents complex technical information/analysis, responding effectively to questions from technical staff members and management regularly.
• Support Activities
  • Provides statistical analysis support to the design and development team.
  • Responsible for Test Method Validation activities to support Design Verification Execution.
• Continuous Improvement
  • Keeps updated on recent technical advances within the industry; applies this knowledge to products and processes.

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.
• May contribute to the establishment of business objectives, goals, budgets and costs.

MINIMUM QUALIFICATION REQUIREMENTS

Education

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

Experience

• Minimum 8 years experience.
• Two years of GMP manufacturing experience required.

Skills

• Represents the organization as the prime design quality technical contact on projects. Interacts with senior-level external personnel on significant technical matters often requiring coordination between organizations.
• Experience in software development (testing, developing, quality reviews, etc) and working knowledge of ISO 62304.
• Follows and develops technical specification requirements and provides significant input on technical procedures for various processes that impact multiple disciplines.
• Demonstrated interactive skills in 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 subordinates, junior engineers, technicians, and management.
• Working knowledge of ISO 14971.
• Knowledge and ability to implement GMP practices and FDA regulations.
• Knowledge and ability to implement FDA or regulatory requirements as necessary.
• Knowledge of product development processes including reliability growth, design quality implementation, design controls, statistics, test method validation.
• Driver for acquiring resources and building consensus across products.
• Demonstrated skills in technical innovation, technical leadership.
• Solicits and accepts the ideas of others while actively contributing to an environment conducive to open communication.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Knowledge and use of relevant PC software applications with skills to use them effectively.

-Or-

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

LOCATION

Lakewood, Colorado - Open to candidates willing to relocate to the area. 

TRAVEL 

Requires travel based on business needs.

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.

Target Pay Range:  $123,600.00 to $154,500.00  -  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.