Sr. Machine Engineer II
Elkton, MD, US
Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.
We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.
At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.
Join us and help shape wherever we go next!
Advancing healthcare with heart
Job Summary
Terumo Medical Corporation is a market leader in minimally-invasive entry site management, lesion access and embolization solutions. This role will work to develop new machines, processes and automation concepts for the production of medical devices. The Senior, Machine 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.
Job Details/Responsibilities
1. Work with internal customers to collect user and project requirements for new machine and automation projects as well as upgrades to existing equipment.
2. Design and evaluate machinery prototypes using a combination of internal and external resources to demonstrate compliance with requirements and process robustness.
3. Provide support in cost and capacity modeling as well as resource planning estimates for project assignments.
4. Provide technical leadership to resolve automation and machinery issues. This includes impact on product in regards to fit, form, function and performance.
5. Provide engineering expertise to the design, fabrication, development, installation, validation and qualification of equipment to ensure proper functionality.
6. 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.
7. Assign, delegate, and monitor the completion of engineering tasks or projects to lower level engineers.
8. Serve as a Subject Matter Expert (SME) in one or more engineering disciplines and/or specific technical skillsets.
9. Recommend and implement engineering process improvements.
10. Lead project management activities and management of machine/equipment suppliers.
11. Oversee tooling and machine builds and designs with internal and external shops.
12. 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.
13. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
14. Performs other job related duties assigned.
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Compensation / 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 advantage 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. $118,000 - $163,000
Knowledge, Skills and Abilities (KSA)
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- 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 is required
- Strong equipment design skills
Qualifications/ Background Experiences
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- 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
It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.
Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage 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. Range for role is $119,000 - $163,000.