New Product Development Sr Engineer II
1 month ago
Job Summary
The NPD Senior Engineer II position is responsible for providing technical expertise, leadership and planning to a large or several smaller technical projects. The NPD Senior Engineer II uses their breadth of engineering knowledge and product development experiences to serve as a technical team leader providing engineering guidance, oversight and coaching to other engineers. The NPD Sr. Engineer II position is specifically accountable for the product design, development, and technical problem solving of the engineering team working with them.
Job Details/Responsibilities
1. Provide engineering leadership in the design, development, and qualification of products and processes. This may include feasibility studies, designing & 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.
2. Implement technical strategy and implementation of projects to design, develop, and qualify new processes for manufacturing new products or improving existing products / processes.
3. Perform as a Technical Lead on a large project to lead and implement the technical aspects involving coordination with other departments, design, prototype fabrication and/or testing. Projects & tasks to be completed include organizing and leading members of the D&T group, planning and scheduling technical activities, coordinating technical resources (personnel, materials, time, suppliers), and preparing proper documentation.
4. Develop and execute projects in accordance with Terumo new product development process in full compliance with all design control, quality, and company regulations and national and international regulatory body requirements. This activity includes, but is not limited to, the understanding of change control, validation, documentation practices, process control and design control requirements.
5. Contribute to project performance team meetings on behalf of the project technical team in order to provide ideas, methods, or designs for performance improvement.
6. Prepare & lead technical design reviews to a cross-functional and technical team.
7. Prepare and present product designs, production processes and related activities to upper management.
8. Communicate with various levels in other sections within Terumo for related projects or progress (i.e. daily interactions with managers, supervisors, NPD engineers and technicians, production personnel, purchasing, logistics, etc...) and with counterparts at other Terumo locations.
9. Implement product performance and design strategies. Define and write test plans/protocols, perform testing, analyze results, suggest recommendations and/or conclusions and document clearly and completely in technical reports. These reports could be to support product development prototype evaluations, or could be submitted to the FDA to support new product clearance or claims.
10. 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 NPD Laboratory and sometimes 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 experience in the development of global Medical Devices in accordance with global regulatory and quality standards and requirements.
o Demonstrated understanding of the cross-functional interactions needed for the development of new products within FDA design control guidelines.
o Demonstrated understanding of cardiology and peripheral interventional procedures and the medical devices used in those procedure.
o Demonstrated strong analytical and problem solving skills; ability to solve complex problems and implement solutions or processes.
o Demonstrated ability to create a development strategy and technical approach for a large medical device project and coordinate with applicable cross-functional leaders to gain alignment.
o Demonstrated ability to lead the design and development of a new or novel medical device on a bench top or pilot line scale.
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.
Qualifications/ Background Experiences
- BS in Mechanical, Biomedical, or similar engineering discipline with 12+ years of experience with increasing responsibility in Product Development in the medical device field
- Advanced degree in Engineering preferred.
-
New Product Development Sr Engineer II
2 weeks ago
Elkton, United States Terumo Medical Corporation Full timeJob Summary The NPD Senior Engineer II position is responsible for providing technical expertise, leadership and planning to a large or several smaller technical projects. The NPD Senior Engineer II uses their breadth of engineering knowledge and product development experiences to serve as a technical team leader providing engineering guidance, oversight and...
-
NPD Sr Engineer II
3 weeks ago
Elkton, United States Terumo Medical Corporation Full timeJob SummaryThe NPD Senior Engineer II position is responsible for providing technical expertise, leadership and planning to a large or several smaller technical projects. The NPD Senior Engineer II uses their breadth of engineering knowledge and product development experiences to serve as a technical team leader providing engineering guidance, oversight and...
-
Senior Product Development Engineer
3 days ago
Elkton, Maryland, United States Terumo Medical Corporation Full timePosition OverviewThe Senior Product Development Engineer role is pivotal in delivering technical guidance, leadership, and strategic planning for significant technical initiatives. This position leverages extensive engineering expertise and product development experience to act as a technical team leader, offering mentorship and direction to fellow...
-
Senior Product Development Engineer
3 days ago
Elkton, Maryland, United States Terumo Medical Corporation Full timePosition OverviewThe Senior Product Development Engineer role is essential for delivering technical guidance, leadership, and strategic planning across multiple engineering projects. This position leverages extensive engineering expertise and product development experience to act as a technical team leader, offering direction, mentorship, and support to...
-
Senior Product Development Engineer
3 days ago
Elkton, Maryland, United States Terumo Medical Corporation Full timePosition OverviewThe Senior Product Development Engineer is tasked with delivering technical leadership and strategic planning for significant engineering projects. This role leverages extensive engineering expertise and product development experience to guide and mentor a team of engineers, ensuring high-quality design and effective problem resolution.Key...
-
Sr. Engineer I
1 day ago
Elkton, United States tapwage Full timeTerumo 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,...
-
Senior NPD Engineer II
4 days ago
Elkton, Maryland, United States Terumo Medical Corporation Full timePosition OverviewThe Senior NPD Engineer II role is pivotal in delivering technical leadership and strategic planning across multiple technical initiatives. This position leverages extensive engineering expertise and product development experience to guide a team of engineers, ensuring effective design and problem-solving throughout the product lifecycle.Key...
-
Senior NPD Engineer II
4 days ago
Elkton, Maryland, United States Terumo Medical Corporation Full timePosition OverviewThe Senior Engineer II for New Product Development is tasked with delivering technical leadership, expertise, and strategic planning across multiple technical initiatives. This role leverages extensive engineering knowledge and product development experience to guide and mentor a team of engineers, ensuring effective problem-solving and...
-
Senior NPD Engineer II
1 week ago
Elkton, Maryland, United States Terumo Medical Corporation Full timePosition OverviewThe Senior NPD Engineer II role is crucial for delivering technical leadership and strategic planning across multiple engineering projects. This position leverages extensive engineering expertise and product development experience to guide and mentor fellow engineers, ensuring effective technical solutions and project execution.Key...
-
NPD Design Engineer II
3 weeks ago
Elkton, United States Terumo Medical Corporation Full timeJob SummaryThe NPD Engineer 2 position is responsible for providing technical expertise, leadership and planning to smaller projects. The NPD Engineer 2 is typically a technical team member. The NPD Engineer II Design Engineer position is specifically accountable for the product design, development, and technical problem solving. This position executes the...
-
Complaints Engineer II
2 months ago
Elkton, United States Terumo Medical Corporation Full timeThe Complaints Engineer II is responsible for analyses, evaluation and product investigation of complaints received from external customers with respect to business objectives and in compliance with Food and Drug Administration (FDA), International Standards Organization (ISO), Quality System Requirements (QSR), EU MDR, and other regulatory guidelines....
-
Complaints Engineer II
2 months ago
Elkton, United States Terumo Medical Corporation Full timeThe Complaints Engineer II is responsible for analyses, evaluation and product investigation of complaints received from external customers with respect to business objectives and in compliance with Food and Drug Administration (FDA), International Standards Organization (ISO), Quality System Requirements (QSR), EU MDR, and other regulatory guidelines....
-
Sr Project Manager NPD
2 months ago
Elkton, United States Terumo Medical Corporation Full timeJob Summary: The Sr. Project Manager position, reporting directly to the Sr. Project Manager/ PM Manager, is responsible for serving as an organizational leader for planning and executing the cross-functional execution of one or more complex projects within a clinical, technical, or business area of Terumo Medical Corporation (TMC). The Sr. Project Manager...
-
Sr Project Manager NPD
2 months ago
Elkton, United States Terumo Medical Corporation Full timeJob Summary: The Sr. Project Manager position, reporting directly to the Sr. Project Manager/ PM Manager, is responsible for serving as an organizational leader for planning and executing the cross-functional execution of one or more complex projects within a clinical, technical, or business area of Terumo Medical Corporation (TMC). The Sr. Project Manager...
-
MES Quality Engineer II
3 months ago
Elkton, United States Terumo Medical Corporation Full time*We are not able to provide sponsorship for this role now or in the future. This also includes OPT. Greencard holders or US Citizens at this time*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...
-
Principal or Sr. Principal Engineer
2 weeks ago
Elkton, United States Northrop Grumman Full timeRequisition ID: R10166039 Category: Engineering Location: Elkton, Maryland, United States of America Clearance Type: Secret Telecommute: No- Teleworking not available for this position Shift: 1st Shift (United States of America) Travel Required: Yes, 10% of the Time Positions Available: 1 At Northrop Grumman, our employees have incredible...
-
Lead Engineer in Product Innovation
4 days ago
Elkton, Maryland, United States Terumo Medical Corporation Full timePosition OverviewThe Senior Engineer for New Product Development is tasked with delivering technical leadership, expertise, and strategic planning across multiple technical initiatives. This role demands a comprehensive understanding of engineering principles and product innovation, serving as a pivotal technical leader who provides guidance, oversight, and...
-
Engineer II
2 months ago
Elkton, United States Pyramid Consulting, Inc Full timeImmediate need for a talented Engineer II -(Associate). This is a 12+ Months Contract opportunity with long-term potential and is located in Elkton, VA (Onsite). Please review the job description below and contact me ASAP if you are interested.Job ID:24-34200Pay Range: $35 - $41/hour. Employee benefits include, but are not limited to, health insurance...
-
Engineer II
2 months ago
Elkton, United States Pyramid Consulting, Inc Full timeImmediate need for a talented Engineer II -(Associate). This is a 12+ Months Contract opportunity with long-term potential and is located in Elkton, VA (Onsite). Please review the job description below and contact me ASAP if you are interested.Job ID:24-34200Pay Range: $35 - $41/hour. Employee benefits include, but are not limited to, health insurance...
-
Senior Director of Engineering
3 months ago
Elkton, United States Terumo Medical Corporation Full timeWe 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...