Engineer 2 - Design Quality

Requisition ID:  33563  

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.

Join our team as a Design Quality Engineer 2 (DQE2) and play a pivotal role in delivering exceptional product designs that improve patient lives. As a key member of our development team, you’ll ensure compliance with customer, regulatory, and business requirements while driving robust, high-quality designs from concept to commercialization. Supporting innovative medical devices and laboratory products with mechanical, electrical, and software elements, you’ll leverage your technical and quality expertise to influence product development, enhance design robustness, and address compliance concerns within the Global Quality Management System.

ESSENTIAL DUTIES

• Work in a cross-functional, collaborative, team-based environment to drive product quality during design and development including the completion of project design quality deliverables.

• Ensure compliance to QMS and Design Control processes and procedures including requirement and specification development, verification, validation, human factors, and process qualification.
• Facilitate and support risk management activities such as FMEA and hazard analysis.
• Contribute to the development and refinement of Design Control policies and procedures to ensure they comply with appropriate standards, regulations, and industry best practice
• Follows department processes and regularly makes recommendations for processes and procedural improvements.
• Anticipate project roadblocks, provide direction for navigating regulations, the quality system, and supporting applications including escalation as required.
• Leads root cause analysis for deviations and quality design issues to solve moderately complex problems and recommend solutions. 

• Performs investigation for quality issues and drives product and systemic improvements through CAPA and change management.
• Provides quality guidance for technical reports, charts, and graphs to support project recommendations and responds to questions from staff members and management.

• Supports data analysis and decision making through robust statistical methods.
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
• May contribute to the development of procedures for technical or business processes.

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’s of Science degree or Master of Science degree in Engineering preferred.

Experience

• Minimum 2 years experience.
• Two years of GMP manufacturing experience required.

Skills

• Requires demonstrated skills in technical innovation, technical leadership, mechanical or chemical engineering, fluids engineering, and cellular biology. 
• Demonstrated interactive skills in, cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team member, team behavior, and support for engineers, technicians, and management.
• Represents the organization as design quality contact on projects. Interfaces with staff, suppliers, and external subject matter experts to resolve technical issues.
• Follows technical specification requirements and provides input on technical procedures on various processes that impact multiple disciplines.
• 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 desired including: reliability growth, design quality implementation, design controls, statistics, test method validation.
• Solicits and accepts the ideas of others, as well as actively contributes 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 and skills to use them effectively.

-Or-

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

LOCATION

Lakewood, Colorado - Hybrid - 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:  $82,000.00 to $102,500.00  -  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:  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.