Engineer 2 - Global Quality Risk Management

Requisition ID:  32391  

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 Global Quality Risk Management Engineer will work with the Risk Management Process Owner (GPO) to develop and maintain Quality Management Systems related to Risk Management and ensures alignment and appropriate integration with the company’s quality system procedures and processes.  The Risk Management Engineer will play an integral role in designing and implementing quality systems to interface with multiple functional areas from R&D, clinical and scientific, operations, regulatory and quality to support the successful development, transfer, sustaining, and post market monitoring activities of all product lines, including both new product platforms and enhancements to existing products. Work requires the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria. 

ESSENTIAL DUTIES

• Responsible for the development and maintenance of Global Risk Management quality procedures and applicable quality plans in compliance with ISO 13485, ISO 14971, EU MDR, CMDR, and FDA Quality System Regulations.
• Conducts studies and makes recommendations for the purchase and implementation of new technologies, practices, tools, and equipment to maximize site effectiveness.
• Develops and implements effective training programs related to Risk Management and Post Market Surveillance to achieve and maintain quality system and regulation awareness, ISO certifications and Quality System compliance.
• Works with global QMS process owners to develop and implement risk-based strategy across the company.
• Ensures alignment of product hazard analysis for consistent decision making and actions across all functional areas and post-market activities.
• Develops and maintains Risk Management File documentation such as FMEAs, Hazard Analyses, Risk Management Plan and Risk Management Report.
• Works with Risk Management software to ensure Risk Management Files are executed per company and industry standards.
• Works closely with global medical safety to maintain the company’s Master Harms list.
• Collaborates with clinical affairs, quality, and regulatory compliance departments to ensure appropriate monitoring and feedback through post market data.
• Implements and understands FDA or regulatory requirements as necessary.
• Ensures compliance with Quality System regulations and safe working practices.
• Utilizes technical skills to evaluate proposed solutions, adaptations, and modifications to projects.
• Receives assigned project leadership responsibilities on a portion of major significant projects and will be given responsibility for smaller projects.
• Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.                  
• Handles frequent inter-organizational customer contacts.  Represents the organization in providing solutions to difficult technical issues associated with global risk management systems.
• Presents effectively complex technical information/analysis and responds to questions from technical staff members and management.   
• Interacts with peers across projects to secure resources and commitments.
• Advises team members pro-actively on technical ideas.
• Works cooperatively and effectively within a team environment to achieve common goals and results, often influencing the outcome of the team(s).
• May provide work direction to 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 or Master of Science Degree in Engineering, preferred.

Experience

• Minimum 2 year’s experience.

Skills

• Solid knowledge in Risk Management and Post Market Surveillance regulatory requirements.
• Proven ability to solve practical problems in a collaborative manner which yields effective compliance with QMS and external standards while allowing for the use of efficient and flexible implementation approaches.
• Demonstrated skills in technical innovation, technical leadership, quality engineering, 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, coordinating with cross functional team members, and support for senior engineers, technicians, and management.
• Provides significant input on technical procedures for various processes that impact multiple disciplines.
• Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
• Regularly and effectively presents complex technical information/analysis and responds to questions from technical staff members and management.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Knowledge and use of relevant PC software applications and skills to use them effectively.
• Understanding of and adherence to GMP practices and FDA regulations.

-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:  $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.