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Design Quality Engineer II

Company: TerumoBCT, Inc.
Location: Lakewood
Posted on: March 13, 2018

Job Description:

State: Colorado (US-CO)

JOB TITLE: E2 Design Quality Engineer


This position represents the quality organization as an integral team member on development projects for medical devices. The Design Quality Engineer (QE) ensures compliance to QMS and design control process and procedures. They ensure adherence to customer and regulatory requirements are demonstrated and help to ensure successful transfer of the design to manufacturing.

Work requires independent evaluation, selection and application of standard engineering techniques, procedures, and criteria, using judgment and ingenuity in making minor adaptations and modifications. Assignments include equipment design and development, tests of materials, preparation of specifications, process study, research investigations, report preparation and other activities of limited scope. Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, and company practices and policies.


* Collaborate closely with I&D PMO and project leads to bring products to market

* Ensure compliance to QMS and design control processes and procedures

* Facilitate and support risk management activities such as FMEA and risk management

* Contribute to the development and refinement of Design Control policies and procedures to ensure they comply with appropriate standards, regulations, and industry best practice

* Work in a cross-functional, collaborative, team-based environment;

* Anticipate roadblocks, provide direction for navigating the quality system and supporting applications.

* 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

* Ensures that process and equipment designs are compliant with all Company policies and procedures as well as all Local, State, and Federal directives, laws and regulations.

* Provides work direction to engineering support staff.

* Takes initiative and demonstrates inquisitive approaches to solve moderately complex problems, identifying problems, generating alternatives and recommending solutions.

* Follows department processes and regularly makes recommendations on these processes.

* Follows technical specification requirements, developing reports, charts and graphs to support project recommendations and responds to questions from technical staff members and management.

* Works cooperatively and effectively in a team environment or across teams to achieve common goals and results.

* Analyzes data and presents it in appropriate forums.


* Work assignments may require additional development and a maturing or broadening of in-depth engineering skill(s).

* May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.



* 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.


* Minimum 2 years experience.

* Two years of GMP manufacturing experience required.


* Requires demonstrated skills in technical innovation, technical leadership, mechanical and or chemical engineering, fluids engineering, and cellular biology.

* Requires 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, provides support for subordinates, junior engineers, technicians, and management.

* Mechanical and electronic ability and aptitude to assist with equipment trouble-shooting.

* Interfaces with staff, suppliers, and external subject matter experts to resolve technical issues and train and provide work direction to operators and production service technicians.

* Understanding of and adherence to GMP practices and FDA regulations.

* Knowledge and ability to implement 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.

* Knowledge of U.S., European and other international regulations, standards and guidance applicable to medical device development (e.g. ISO 13485, FDA GMP, 21 CFR 820, ISO 14971)

* Must be able to multi-task, prioritize and work within a schedule


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


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.


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, 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.

We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks. As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace. For more information about Terumo BCT, visit our website

Join Terumo BCT as we unlock the potential of blood. We are a global leader in blood component and cellular technologies, and the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.

As the largest medical device manufacturing company headquartered in Colorado, we are home to more than 2,300 associates and our products are in use in more than 125 countries and territories. Our Global footprint includes more than 5,500 associates and partners with regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.

Our company has almost $1B in annual revenues and has been voted and recognized as:

* Largest corporate sponsor in Rocky Mountain Region for Leukemia and Lymphoma Society (LLS)

* Winner of the Association for Talent Development (ATD) BEST Award for providing exceptional employee learning and talent development (2011 & 2012)

* One of Colorado s Healthiest Employers by Denver Business Journal (2014 & 2015)

* Recipient of the Way to Go Employer award through the Denver Regional Council of Governments (DRCOG) 2015

Our award-winning culture embraces:

* Leading technology through innovation and R&D

* Wellness programs

Keywords: TerumoBCT, Inc., Denver, Design Quality Engineer II, Engineering, Lakewood, Colorado

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