Terumo Medical Corporation
Senior Machine and Automation Engineer II
Job Summary: Terumo Medical Corporation is a market leader in minimally‑invasive entry site management, lesion access and embolization solutions. The Senior Machine and Automation Engineer II role will develop new machines, processes and automation concepts for the production of medical devices. The Senior Machine and Automation Engineer II will oversee everything from initial concept through commissioning the machinery into the manufacturing site. He or she is recognized as a technical expert in their area of engineering.
Responsibilities
Work with internal customers to collect user and project requirements for new machine and automation projects as well as upgrades to existing equipment.
Design and evaluate machinery prototypes using a combination of internal and external resources to demonstrate compliance with requirements and process robustness.
Provide support in cost and capacity modeling as well as resource planning estimates for project assignments.
Provide technical leadership to resolve automation and machinery issues. This includes impact on product in regards to fit, form, function and performance.
Provide engineering expertise to the design, fabrication, development, installation, validation and qualification of equipment to ensure proper functionality.
Provide mentorship and guidance to lower level engineers and technicians to assist in completion of technical work and to develop their technical knowledge and engineering skillset.
Assign, delegate, and monitor the completion of engineering tasks or projects to lower level engineers.
Serve as a Subject Matter Expert (SME) in one or more engineering disciplines and/or specific technical skillsets.
Recommend and implement engineering process improvements.
Lead project management activities and management of machine/equipment suppliers.
Oversee tooling and machine builds and designs with internal and external shops.
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain and follow TMC Quality System requirements; including but not limited to understanding of change control, validation, documentation practices, and design control requirements.
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Perform other job related duties assigned.
Position Requirements
Ability to generate machine user requirements
Ability to draft and execute equipment validations
Ability to manage internal and external suppliers
Demonstrated ability in the use of critical thinking, problem solving and analysis
Effective communication skills both verbal and written
BS in Engineering (Mechanical, Electrical, or similar technical field) and 10 or more years of experience with manufacturing processes or equivalent education and experience
Experience in an FDA regulated industry, medical device or pharmaceutical preferred
Experience with manufacturing equipment design and procurement
Hands‑on experience with manufacturing equipment ranging from manual to fully automated preferred
SolidWorks experience is a plus
Benefits We provide competitive and comprehensive benefit options that allow you to design your own plan based on your individual needs which include: paid vacation, paid holidays, health, dental and vision benefits, 401(k) with matching contributions, tax‑advantaged savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long‑term disability, short‑term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skill set, knowledge, geography, education, business needs and market demand. $119,000 - $163,000
Join us, and help shape wherever we go next!
Advancing healthcare with heart
#J-18808-Ljbffr
Responsibilities
Work with internal customers to collect user and project requirements for new machine and automation projects as well as upgrades to existing equipment.
Design and evaluate machinery prototypes using a combination of internal and external resources to demonstrate compliance with requirements and process robustness.
Provide support in cost and capacity modeling as well as resource planning estimates for project assignments.
Provide technical leadership to resolve automation and machinery issues. This includes impact on product in regards to fit, form, function and performance.
Provide engineering expertise to the design, fabrication, development, installation, validation and qualification of equipment to ensure proper functionality.
Provide mentorship and guidance to lower level engineers and technicians to assist in completion of technical work and to develop their technical knowledge and engineering skillset.
Assign, delegate, and monitor the completion of engineering tasks or projects to lower level engineers.
Serve as a Subject Matter Expert (SME) in one or more engineering disciplines and/or specific technical skillsets.
Recommend and implement engineering process improvements.
Lead project management activities and management of machine/equipment suppliers.
Oversee tooling and machine builds and designs with internal and external shops.
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain and follow TMC Quality System requirements; including but not limited to understanding of change control, validation, documentation practices, and design control requirements.
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Perform other job related duties assigned.
Position Requirements
Ability to generate machine user requirements
Ability to draft and execute equipment validations
Ability to manage internal and external suppliers
Demonstrated ability in the use of critical thinking, problem solving and analysis
Effective communication skills both verbal and written
BS in Engineering (Mechanical, Electrical, or similar technical field) and 10 or more years of experience with manufacturing processes or equivalent education and experience
Experience in an FDA regulated industry, medical device or pharmaceutical preferred
Experience with manufacturing equipment design and procurement
Hands‑on experience with manufacturing equipment ranging from manual to fully automated preferred
SolidWorks experience is a plus
Benefits We provide competitive and comprehensive benefit options that allow you to design your own plan based on your individual needs which include: paid vacation, paid holidays, health, dental and vision benefits, 401(k) with matching contributions, tax‑advantaged savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long‑term disability, short‑term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skill set, knowledge, geography, education, business needs and market demand. $119,000 - $163,000
Join us, and help shape wherever we go next!
Advancing healthcare with heart
#J-18808-Ljbffr