at Terumo BCT
Posted on May. 2, 2017
JOB TITLE: PRODUCT LIFECYCLE ENGINEER III, DISPOSABLES
Provide cross functional, influential leadership and product subject matter expertise to the company over the life cycle of the product(s) assigned.
* Acts as the subject matter expert on assigned Disposables product line(s) over the the life cycle of the product.
* Reviews and approves product documentation that may include design reviews, verifications, lower level requirements, and product specifications, as applicable.
* Consult and advise on product changes through design control processes and change control processes including: design change implementation, production quality issues, field quality issues, production process changes, regulatory filings/registrations, supplier quality changes.
* Advise on content for systems product documentation including: Product Requirements, System Architecture, User and Environmental Analysis, and Risk Management
* May contribute guidance for standards for product testing and testing procedures; ensures consistency across product lines where applicable by partnering with other SMEs.
* Reviews and updates Technical File for assigned product(s), and understands applicability of required standards.
* Could perform product training for other associates
* May utilize hands on time with the products and platform to maintain product knowledge or train other associates
* Working knowledge of cross-functional and related technical areas (such as Quality, Manufacturing and Regulatory).
* Advises team members pro-actively on technical ideas and product knowledge and promotes development of team work and product knowledge.
* Participates in inter-organizational and outside customer contacts as needed.
* Represents the organization in providing solutions to difficult technical issues associated with specific product(s) and projects.
* Works cooperatively and effectively within a team environment to achieve common goals and results, often influencing the outcome of the team(s).
* Presents complex technical information and analysis, and responds effectively to questions from technical staff members and management, as needed.
* Displays accessibility and sought out for consultation on a broad range of complex technical and industry issues by engineering staff and management.
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.
* Must consult or collaborate with Product Lifecycle Engineers for interfacing equipment.
MINIMUM QUALIFICATION REQUIREMENTS
* 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 is preferred.
* Minimum 4 years experience.
* Two years of GMP manufacturing experience required.
* 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 subordinates, junior engineers, technicians, and management.
* Experience in medical device, pharmaceutical, or other regulated industry.
* Represents the organization as the prime technical contact on products. Interacts with senior level external personnel on significant technical matters often requiring coordination between organizations.
* Follows and consults in the development of technical specification requirements and provides significant input on technical procedures on various processes that impact multiple disciplines.
* Exhibits strong managerial courage both technically and personally
* Requires demonstrated skills in technical innovation, technical leadership, mechanical or chemical engineering, fluids engineering, and cellular biology.
* Exhibits strong technical problem solving skills.
* Understands and adheres to GMP practices and FDA regulations.
* Possesses knowledge and ability to implement FDA or other regulatory requirements as necessary.
* Demonstrated ability to communicate effectively both verbally and in writing.
* Possesses knowledge and use of relevant PC software applications and skills to use them effectively.
* Ability to train other associates on product(s) function, use, risks, and differentiation in the market.
* Possesses natural inquisitiveness. Willing to question to understand why, what and how.
* Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
* Possesses skills necessary for potential interactions with customers
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.
Must be able to operate in a blood lab environment.
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 domestic and international 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 www.terumobct.com/careers .
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, Hong Kong 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
* Commitment to quality
* An environment that values, respects and rewards your individual contributions
* A philosophy of intentional growth and responsiveness to world health issues
Click Here to see what our associates have to say about our culture.
Each associate has a positive impact on our future by:
* Connecting to the lives of the patients we ultimately serve
* Growing through professional and leadership development activities
* Sharing company success through incentive plans
IF YOU ARE THE BEST AT WHAT YOU DO AND WANT TO DO WORK THAT IS CHANGING THE DELIVERY OF HEALTHCARE GLOBALLY, WE INVITE YOU TO WORK WITH US NOW TO SEE HOW WE CAN UNLOCK YOUR POTENTIAL.