Terumo Medical Corporation
New Product Development Sr Engineer II
Terumo Medical Corporation, Elkton, Maryland, us, 21922
Overview
The NPD Senior Engineer II position at Terumo Medical Corporation provides technical leadership and planning for large or multiple technical projects. The role uses breadth of engineering knowledge and product development experience to serve as a technical team leader, providing engineering guidance, oversight and coaching to other engineers. The position is specifically accountable for product design, development, and technical problem solving within the engineering team. Base pay range
$116,000.00/yr - $160,000.00/yr The salary range for this position is $116,000 - $160,000 based on experience and a 15% target bonus. Responsibilities
Provide engineering leadership in the design, development, and qualification of products and processes. This may include feasibility studies, designing and implementing evaluations (DOEs), and providing technical input for justification of project and design. Responsible for contributing to the DHF and regulatory submittals, creating SOPs, and for providing training to ensure proper design transfer. Implement technical strategy and execution of projects to design, develop, and qualify new processes for manufacturing new products or improving existing products/processes. Serve as Technical Lead on large projects, coordinating with other departments, design, prototype fabrication and testing; organize and lead the D&T group, plan and schedule technical activities, coordinate resources, and prepare documentation. Develop and execute projects in accordance with Terumo's New Product Development process, ensuring full compliance with design control, quality, and regulatory requirements, including change control, validation, documentation practices, process control and design control. Contribute to project performance meetings to provide ideas, methods, or designs for performance improvement. Prepare and lead technical design reviews with cross-functional and technical teams. Prepare and present product designs, production processes, and related activities to upper management. Communicate with various levels within Terumo and with counterparts at other Terumo locations to coordinate projects and progress. Implement product performance and design strategies; define and write test plans/protocols, perform testing, analyze results, and document conclusions in technical reports suitable for internal use or FDA submissions. Perform other job-related duties as assigned. Working Conditions/Physical Requirements
Located in Terumo manufacturing facility in Elkton, MD. Office environment, NPD Laboratory, and occasional manufacturing areas. Access to hospitals and hospital operating rooms may be required for clinician interactions and observations related to new product development. Knowledge, Skills and Abilities (KSA)
Extensive experience in developing global medical devices in accordance with global regulatory and quality standards and requirements. Understanding of cross-functional interactions needed for the development of new products within FDA design control guidelines. Understanding of cardiology and peripheral interventional procedures and the medical devices used in those procedures. Strong analytical and problem-solving skills; ability to solve complex problems and implement solutions or processes. Ability to create a development strategy and technical approach for large medical device projects and coordinate with cross-functional leaders to gain alignment. Ability to lead the design and development of a new or novel medical device on bench-top or pilot-line scale. Strong communication skills; ability to explain complex engineering problems to non-engineers; ability to deliver presentations to executive management; ability to prepare detailed technical reports for FDA submissions. Qualifications/Background Experiences
BS in Mechanical, Biomedical, or related engineering discipline with 12+ years of increasing responsibility in medical device product development. Advanced degree in Engineering preferred. Seniority level
Mid-Senior level Employment type
Full-time Job function
Industries: Medical Equipment Manufacturing Benefits
Medical insurance Vision insurance 401(k) Tuition assistance Paid paternity leave Paid maternity leave
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The NPD Senior Engineer II position at Terumo Medical Corporation provides technical leadership and planning for large or multiple technical projects. The role uses breadth of engineering knowledge and product development experience to serve as a technical team leader, providing engineering guidance, oversight and coaching to other engineers. The position is specifically accountable for product design, development, and technical problem solving within the engineering team. Base pay range
$116,000.00/yr - $160,000.00/yr The salary range for this position is $116,000 - $160,000 based on experience and a 15% target bonus. Responsibilities
Provide engineering leadership in the design, development, and qualification of products and processes. This may include feasibility studies, designing and implementing evaluations (DOEs), and providing technical input for justification of project and design. Responsible for contributing to the DHF and regulatory submittals, creating SOPs, and for providing training to ensure proper design transfer. Implement technical strategy and execution of projects to design, develop, and qualify new processes for manufacturing new products or improving existing products/processes. Serve as Technical Lead on large projects, coordinating with other departments, design, prototype fabrication and testing; organize and lead the D&T group, plan and schedule technical activities, coordinate resources, and prepare documentation. Develop and execute projects in accordance with Terumo's New Product Development process, ensuring full compliance with design control, quality, and regulatory requirements, including change control, validation, documentation practices, process control and design control. Contribute to project performance meetings to provide ideas, methods, or designs for performance improvement. Prepare and lead technical design reviews with cross-functional and technical teams. Prepare and present product designs, production processes, and related activities to upper management. Communicate with various levels within Terumo and with counterparts at other Terumo locations to coordinate projects and progress. Implement product performance and design strategies; define and write test plans/protocols, perform testing, analyze results, and document conclusions in technical reports suitable for internal use or FDA submissions. Perform other job-related duties as assigned. Working Conditions/Physical Requirements
Located in Terumo manufacturing facility in Elkton, MD. Office environment, NPD Laboratory, and occasional manufacturing areas. Access to hospitals and hospital operating rooms may be required for clinician interactions and observations related to new product development. Knowledge, Skills and Abilities (KSA)
Extensive experience in developing global medical devices in accordance with global regulatory and quality standards and requirements. Understanding of cross-functional interactions needed for the development of new products within FDA design control guidelines. Understanding of cardiology and peripheral interventional procedures and the medical devices used in those procedures. Strong analytical and problem-solving skills; ability to solve complex problems and implement solutions or processes. Ability to create a development strategy and technical approach for large medical device projects and coordinate with cross-functional leaders to gain alignment. Ability to lead the design and development of a new or novel medical device on bench-top or pilot-line scale. Strong communication skills; ability to explain complex engineering problems to non-engineers; ability to deliver presentations to executive management; ability to prepare detailed technical reports for FDA submissions. Qualifications/Background Experiences
BS in Mechanical, Biomedical, or related engineering discipline with 12+ years of increasing responsibility in medical device product development. Advanced degree in Engineering preferred. Seniority level
Mid-Senior level Employment type
Full-time Job function
Industries: Medical Equipment Manufacturing Benefits
Medical insurance Vision insurance 401(k) Tuition assistance Paid paternity leave Paid maternity leave
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