Engineer 3 - Design Quality

Requisition ID : 32360

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.

As an Engineer 3 - Design Quality, you will lead and innovate in the development of groundbreaking medical devices. This pivotal role involves ensuring the highest standards of quality and regulatory compliance, from concept through production.

You'll collaborate with cross-functional teams, drive continuous improvement, and implement robust quality systems to enhance patient safety and product performance.

This position represents the quality organization as a team member on development projects. The Design Quality Engineer (QE) ensures compliance with QMS and design controls process and procedures as well as ensures quality design objectives.

Ensure adherence to customer and regulatory requirements to help ensure successful transfer of the design to manufacturing.

If you have a passion for precision, a strong background in medical device engineering, and a commitment to excellence, we invite you to make a significant impact in the healthcare industry with us.

ESSENTIAL DUTIES

• Ensures compliance to QMS and design controls processes and procedures.
• Facilitate and support risk management activities. Highlightsrisks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.
• Contribute to product development and refinement of design through policies and procedures to ensure the comply with appropriate standards, regulations and industry best practice.
• Interacts with team members to ensure DFX implementation, sufficient design requirements, relevance of verification test.
• Work in a cross-functional, collaborative, team-based environment.
• Anticipate roadblocks, provide direction for navigating the quality system.
• Take an active role in Design Reviews to assess quality and compliance.
• Responsible for accurate, independent evaluation of Design History File documentation and overall compliance to the Quality System, perform independent evaluation, selection, and application in making adaptations and modifications to projects.
• Receives assigned total project leadership responsibilities on a portion of major significant projects and will be given total management responsibility for smaller projects.
• Implements and understands FDA or regulatory requirements as necessary.
• Applies technology principles to multiple tasks. Working knowledge of cross-functional and related technical areas.
• Advises team members pro-activelyon technical ideas and promotes skill development of team work.
• Interacts with peers across projects to secure resources and commitments.
• Follows technical specification requirements and provides feedback on various technical processes and procedures.
• Presents effectivelycomplex technical information / analysis, and responds to questions from technical staff members and management.
• 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.

Skills

• Requires demonstrated skills in technical innovation, technical leadership, mechanical and or chemical engineering, fluids engineering, and cellular biology.
• Stronginteractive skills in general communication, 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 subordinates, junior engineers, technicians, and management.
• Strong technical problem-solving skills.
• Experience or desire to gain experience in software development desired (testing, developing, quality reviews etc.) or familiar with ISO 62304.
• Knowledge of product development processes desired including : reliability growth, design quality implementation, design controls, statistics, test method validation.
• Understanding of and adherence to GMP practices and FDA regulations.
• 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.

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 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 : $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 : 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.