Engineer 4, Automated Systems Project Engineering Lead at TerumoBCT, Inc.
Posted in Other 30+ days ago.
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Type: Full Time
Location: Lakewood, Colorado
State: Colorado (US-CO)
JOB TITLE: Engineer 4, Automated Systems Project Engineering Lead
Position provides technical leadership and project management to capital projects supporting medical device manufacturing. Responsibilities include lead engineer, project management, directing resources internal and external to the organization, accountability for the contribution of others and mentoring of technicians and junior engineers. Work content includes but is not limited to: documentation of system requirements, oversight of machine build, acceptance testing, installation and qualification at site location. Engineering resources will be based in Denver Colorado,
requiring travel to vendor location.
* Leads and is accountable for capital projects supporting medical device manufacturing and drives results.
* Guides the successful completion of major programs and may function in a project leadership role. Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives.
* Directs one or more major phases of complex engineering work, utilizing engineering skills to devise entirely new approaches to problems encountered in projects.
* Develops new processes that have a significant impact on multiple disciplines.
* Contributes to the establishment of business objectives, goals, budgets and costs as requested.
* Presents complex technical information/analysis and responds to questions from technical staff members and management regularly and effectively.
* Mentors less experienced engineers and technicians.
* Provides broad-based direction for subordinates and colleagues within functional area and cross functionally.
* Applies technical expertise to complex tasks with in-depth knowledge of related work areas.
* Employs in-depth knowledge of cross functional and related technical areas, applying knowledge to other areas.
* Displays accessibility and sought out for consultation on a broad range of complex technical and industry issues engineering staff and management.
* Works on complex issues where analysis requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
* Keeps updated on recent technical advances within the industry and applies this knowledge to products and processes.
OTHER DUTIES AND RESPONSIBILITIES
* Facilitate the design, installation, and validation of automated systems for medical device manufacturing in a clean room environment.
* Work direction responsibility may include technicians and junior engineers.
* May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
* May contribute to the establishment of business objectives, goals, budgets and costs.
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 s of Science degree or Master of Science degree in Engineering preferred.
* Minimum 8 years experience.
* Two years of GMP manufacturing experience required.
* Knowledge of complex, automated manufacturing systems; specification, build, acceptance testing, installation, commissioning, and qualification.
* Requires demonstrated skills in project management, technical leadership, and can drive a team to deliver results.
* 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.
* Represents the organization as the prime technical contact on projects. Interacts with senior level external personnel on significant technical matters often requiring coordination between organizations.
* Knowledge and ability to implement FDA or regulatory requirements as necessary.
* Driver for acquiring resources and building consensus across products.
* 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.
* Understanding of and adherence to GMP practices and FDA regulations.
* 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.
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 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, 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
* Commitment to quality