Engineer III - Solutions & Distributed Products at Terumo BCT
Solutions product engineer and engineer responsible for releasing new distributed products.
Acts as the solutions product engineer based in Lakewood. Works closely with our international solutions manufacturing site and team to release new solutions products including aspects of project management, design controls, design history files, etc. Responsible for participating in and reviewing changes to existing solutions products.
Works with business development, purchasing, logistics, legal, and suppliers to release new distributed products into our system. Ensure that all of the design control requirements are met and that all business systems are set up to allow for purchasing, ordering, managing, and shipping distributed products.
MINIMUM QUALIFICATION REQUIREMENTS
Education
Requires a Bachelor of Science degree in Engineering. Prefer Industrial, Chemical or Mechanical but all Engineering and Scientific backgrounds may be of interest depending on experience.
Experience
Employees entering this job typically have 4 - 10 years of experience.
Requires experience in chemical or biochemical processes; polymer or plastics processing; medical solutions packaging or processing; manufacturing processes for joining, bonding or modifying plastics; and medical products.
OR
Requires experience in manufacturing, engineering problem solving, and systems development.
OR
Requires experience in mechanical engineering; machine design; centrifugal systems; gear train, pump, and/or sensor design; electromechanical systems; medical products; optics or optical engineering; packaging design; ultrasonics, RF welding, UV cure adhesives or other joining techniques; manufacturing processes; automated manufacturing; and systems engineering.
Skills
• Requires interactive 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.
• Requires demonstrated skills in technical innovation and technical leadership in manufacturing or engineering.
• Preferred Experience includes:
o Experience with medical solutions or drugs including packaging, regulations, and processing
o Experience with medical design controls: verification, validation, inputs, risk analysis
o Analytical statistics
o Assembly process development and improvement
o Medical device development
o Project management tools
o Project leadership
o Working closely with suppliers
o Business fundamentals
o Cross functional leadership or experience with purchasing, logistics, legal, and business development
o Working with international teams and cultural awareness of other areas
o International travel
o Working with or setting up distributed products
o Familiarity or fluency with SAP
Engineering
• Manages solutions product development projects with an international, cross-functional team.
• Prioritizes work and resource allocation to meet established timelines and revenue goals.
• Takes responsibility to organize and direct the efforts of cross-functional team.
• Assigned total project leadership responsibilities on significant projects.
• Generally operates with wide latitude for un-reviewed action or decision. Receives direct supervision and guidance primarily on novel or controversial problems.
• Able to learn and implement FDA and Global regulatory requirements.
• Develops and organizes significant regulatory and engineering technical documentation.
• Carries out engineering assignments of a broad nature exercising considerable judgment and originality.
• Engineering skills are used independently to perform evaluation, selection, and application in product development and modifications to existing products.
• Interprets and applies company policy under direction of supervisor.
• Applies technology principles to multiple tasks. Working knowledge of cross-functional and related technical areas.
• Independently determines and develops approach to solutions. Work is reviewed upon completion for accuracy in meeting objectives.
• Has knowledge of general business environment/ operation and budget/cost awareness.
• Work direction responsibility may include technicians and junior engineers.
Problem Solving
• Identifies risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.
• Works on problems of diverse scope where analysis requires evaluation of a variety of factors.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Demonstrates enthusiasm to learn and share new methods and techniques within several areas.
• Inquisitive approaches to analyze and solve complex problems.
• Learning to cope with change; can shift gears with little direction; can decide and act without having the total picture.
Communication
• Demonstrates the ability to conduct courageous conversations.
• Demonstrates ability to manage conflict and may partner with others to solve problems in order to come to an agreeable outcome.
• Interacts with peers across projects to secure resources and commitments.
• Frequent inter-organizational and outside customer and supplier contacts.. Represents the organization in coordinating and initiating the internal requirements for distributed products.
• Follows technical specification requirements and provides feedback on various technical processes and procedures.
• Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
• Effectively presents complex technical information/analysis, and responds to questions from technical staff members and management.
Teamwork
• Takes initiative to influence team decisions and/or outcomes, sharing expertise with team.
• Actively advises team members on technical ideas and promotes skill development of team/work.
• Participates in setting project objectives and indentifying resource requirements for team.
• Works cooperatively and effectively within an international team environment to achieve common goals and results, often influencing the outcome of the team(s).
• Supports and facilitates within and across projects.
• Initiates and takes ownership of tasks to ensure team results are achieved.
ADDITIONAL INFORMATION
• International travel is required in this role.
• Occasional or regular early morning conference calls may be required in this roll (7 am).
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.
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.
Join Terumo BCT as we unlock the potential of blood. We are the world leader in blood component technology, delivering products, services and solutions for customers and their patients worldwide. Through collaboration with our customers and a commitment to innovation, we are the only company with the unique combination of apheresis, manual and automated whole blood processing and pathogen reduction technologies coupled with robust technology, innovation and core competencies in therapeutic apheresis, cell collections and cell processing.
As the largest medical device manufacturing company headquartered in Colorado we operate in 120 countries with more than 2,600 associates around the world.
Our company has been voted and recognized as a:
• Top five world-class training organization by Training and Development Magazine (2011 & 2012)
Our award-winning culture embraces:
• Leading technology through innovation and R&D
• Wellness programs
• Commitment to quality
• An environment that values and respects your individual contributions
• A philosophy of intentional growth
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, we invite you to work with us now!
Acts as the solutions product engineer based in Lakewood. Works closely with our international solutions manufacturing site and team to release new solutions products including aspects of project management, design controls, design history files, etc. Responsible for participating in and reviewing changes to existing solutions products.
Works with business development, purchasing, logistics, legal, and suppliers to release new distributed products into our system. Ensure that all of the design control requirements are met and that all business systems are set up to allow for purchasing, ordering, managing, and shipping distributed products.
MINIMUM QUALIFICATION REQUIREMENTS
Education
Requires a Bachelor of Science degree in Engineering. Prefer Industrial, Chemical or Mechanical but all Engineering and Scientific backgrounds may be of interest depending on experience.
Experience
Employees entering this job typically have 4 - 10 years of experience.
Requires experience in chemical or biochemical processes; polymer or plastics processing; medical solutions packaging or processing; manufacturing processes for joining, bonding or modifying plastics; and medical products.
OR
Requires experience in manufacturing, engineering problem solving, and systems development.
OR
Requires experience in mechanical engineering; machine design; centrifugal systems; gear train, pump, and/or sensor design; electromechanical systems; medical products; optics or optical engineering; packaging design; ultrasonics, RF welding, UV cure adhesives or other joining techniques; manufacturing processes; automated manufacturing; and systems engineering.
Skills
• Requires interactive 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.
• Requires demonstrated skills in technical innovation and technical leadership in manufacturing or engineering.
• Preferred Experience includes:
o Experience with medical solutions or drugs including packaging, regulations, and processing
o Experience with medical design controls: verification, validation, inputs, risk analysis
o Analytical statistics
o Assembly process development and improvement
o Medical device development
o Project management tools
o Project leadership
o Working closely with suppliers
o Business fundamentals
o Cross functional leadership or experience with purchasing, logistics, legal, and business development
o Working with international teams and cultural awareness of other areas
o International travel
o Working with or setting up distributed products
o Familiarity or fluency with SAP
Engineering
• Manages solutions product development projects with an international, cross-functional team.
• Prioritizes work and resource allocation to meet established timelines and revenue goals.
• Takes responsibility to organize and direct the efforts of cross-functional team.
• Assigned total project leadership responsibilities on significant projects.
• Generally operates with wide latitude for un-reviewed action or decision. Receives direct supervision and guidance primarily on novel or controversial problems.
• Able to learn and implement FDA and Global regulatory requirements.
• Develops and organizes significant regulatory and engineering technical documentation.
• Carries out engineering assignments of a broad nature exercising considerable judgment and originality.
• Engineering skills are used independently to perform evaluation, selection, and application in product development and modifications to existing products.
• Interprets and applies company policy under direction of supervisor.
• Applies technology principles to multiple tasks. Working knowledge of cross-functional and related technical areas.
• Independently determines and develops approach to solutions. Work is reviewed upon completion for accuracy in meeting objectives.
• Has knowledge of general business environment/ operation and budget/cost awareness.
• Work direction responsibility may include technicians and junior engineers.
Problem Solving
• Identifies risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.
• Works on problems of diverse scope where analysis requires evaluation of a variety of factors.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Demonstrates enthusiasm to learn and share new methods and techniques within several areas.
• Inquisitive approaches to analyze and solve complex problems.
• Learning to cope with change; can shift gears with little direction; can decide and act without having the total picture.
Communication
• Demonstrates the ability to conduct courageous conversations.
• Demonstrates ability to manage conflict and may partner with others to solve problems in order to come to an agreeable outcome.
• Interacts with peers across projects to secure resources and commitments.
• Frequent inter-organizational and outside customer and supplier contacts.. Represents the organization in coordinating and initiating the internal requirements for distributed products.
• Follows technical specification requirements and provides feedback on various technical processes and procedures.
• Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
• Effectively presents complex technical information/analysis, and responds to questions from technical staff members and management.
Teamwork
• Takes initiative to influence team decisions and/or outcomes, sharing expertise with team.
• Actively advises team members on technical ideas and promotes skill development of team/work.
• Participates in setting project objectives and indentifying resource requirements for team.
• Works cooperatively and effectively within an international team environment to achieve common goals and results, often influencing the outcome of the team(s).
• Supports and facilitates within and across projects.
• Initiates and takes ownership of tasks to ensure team results are achieved.
ADDITIONAL INFORMATION
• International travel is required in this role.
• Occasional or regular early morning conference calls may be required in this roll (7 am).
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.
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.
Join Terumo BCT as we unlock the potential of blood. We are the world leader in blood component technology, delivering products, services and solutions for customers and their patients worldwide. Through collaboration with our customers and a commitment to innovation, we are the only company with the unique combination of apheresis, manual and automated whole blood processing and pathogen reduction technologies coupled with robust technology, innovation and core competencies in therapeutic apheresis, cell collections and cell processing.
As the largest medical device manufacturing company headquartered in Colorado we operate in 120 countries with more than 2,600 associates around the world.
Our company has been voted and recognized as a:
• Top five world-class training organization by Training and Development Magazine (2011 & 2012)
Our award-winning culture embraces:
• Leading technology through innovation and R&D
• Wellness programs
• Commitment to quality
• An environment that values and respects your individual contributions
• A philosophy of intentional growth
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, we invite you to work with us now!
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