Job Information
Terumo Medical Corporation Principal Engineer in Elkton, Maryland
Principal Engineer
Date: Jun 11, 2024
Req ID: 3381
Location:
Elkton, MD, US
Company: Terumo Medical Corporation
Department: Engineering
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
The Principal Engineer - Process Engineering position is expected to serve in an organizational technical leadership role through their involvement with key elements of the business utilizing their technical and clinical knowledge and experience. The Principal Engineer - Process Engineering position is responsible for providing technological leadership and insight into the development of new production processes, procedures and technologies, the development of technology and product roadmaps, and the continuous development of a multi-year new product development pipeline for the TIS business.
In addition to the above, the Principal Engineer â Process Engineering position is accountable for providing sound technical leadership to new product and process development activities by providing technical direction, insight and coaching to project technical leaders and process leaders in solving complex product/process design, development and production issues. The Principal Engineer â Process Engineering is expected to participate in solving the most complex technical and development issues requiring resolution. This position will also serve as the Subject Matter Expert for the Design for Excellence (DFX) aspect of the processes and design.
Job Details/Responsibilities
Provide organizational engineering leadership in the design, development, and qualification of products, processes, and process equipment in accordance with TMC QA101 Product Development & Design Controls and in full compliance with all design control, quality, and company regulations and national and international regulatory body requirements.
Provide manufacturability insight and guidance to the engineering organization for the design and development of new products to facilitate the development of viable production processes for the products under development.
Contribute to department strategies, management direction and initiatives, and provide high level technical support in management and executive meetings.
Provide complex technical strategy for projects to design, develop, and qualify new processes for manufacturing new products or improving existing products / processes.
Provide engineering leadership and technical expertise to solve complex technical issues on projects and process development. Assist the Technical Leader on a project(s) to lead and implement the technical aspects of large projects.
Provide technical leadership to the performance of formal process validations to ensure their compliance to validation protocols.
As required, serve as a Problem Solver to product and process issues by providing technical leadership to understanding the technical issues and applying the proper engineering tools and techniques for their resolution and implementation of any required process modifications.
Develop and maintain effective working relationships and proactively communicate with senior engineers and leaders in D&T, Manufacturing Engineering, Quality Assurance, and Manufacturing within TMC to partner in the development/transfer of manufacturing processes within the Elkton facility.
Participate in and contribute to project team meetings, Design Reviews and other formal project reviews.
Participate in and provide input to the development of project planning activities to include project cost and schedule estimates and performance requirements definition.
Prepare and present technical presentations to all levels of personnel in a manner that effectively communicates technical activities in an understandable way to the target audience.
Performs other job related duties assigned.
Working Conditions/Physical Requirements
This position will be located in the Terumo manufacturing facility located in Elkton, MD. The position will perform required duties in an office environment, the D&T Laboratory and Process Pilot area, and within manufacturing areas. Access to hospitals and hospital operating rooms will be required to meet with clinicians and observe relevant clinical procedures associated with new product development activities.
Knowledge, Skills and Abilities (KSA)
o Extensive technical leadership and experience in the development of new manufacturing processes for global Medical Devices or other highly regulated industries in accordance with global regulatory and quality standards and requirements.
o Experience in the application of Design for Six Sigma (DFSS), Design for Manufacturability (DFM); Design for Assembly (DFA), and Lean Six Sigma principles and tools.
o Demonstrated understanding of the cross-functional interactions needed for the development of new products and manufacturing processes within FDA design control guidelines.
o Organizationally recognized exceptional analytical and problem solving skills; ability to solve the most complex problems and implement solutions or processes.
o Demonstrated ability to create a process development strategy and technical approach for a large medical device project and coordinate with applicable cross-functional leaders to gain alignment.
o Demonstrated technical leadership in the design, development and implementation through production qualification of a new or novel medical device production process.
o Strong communications skills. Demonstrated ability to understand and explain complex engineering problems to non-engineering personnel; the ability to create and deliver presentations to executive management; and the ability to prepare detailed Technical Reports appropriate to send to the FDA.
o Effective use of MS Office Suite.
Qualifications/ Background Experiences
BS in Mechanical, Biomedical, or similar engineering discipline from an accredited university or college with 15 or more years of working experience with increasing responsibility in Product and Process Development in the medical device field; advanced degree in Engineering preferred.
Six Sigma Black Belt certification is desirable.
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.