Sr. Design Assurance Systems Engineer, MDR
Teleflex

Chelmsford, Massachusetts


Expected Travel: None

Requisition ID:3930

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation - a relentless pursuit of identifying unmet clinical needs - to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner® and Turnpike® Catheters, AC3 Optimus™ Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

Position Summary

• Fulfill design assurance role on new product development (conception to launch) and sustaining projects
• Lead planning and execution of Design Controls, Risk Management, Human Factors, Test Method Development and Validation, Design Verification/Validation for new and existing products.
• Support Regulatory Affairs with creating submissions and responding to submission questions.
• Primary responsibility is New Product Development; secondary responsibility is Sustaining Engineering.
• Continued support and optimization of DA centric New Product Development deliverables and processes, accounting for cross functional system interactions.

Principal Responsibilities

• Participate and lead New Product Development Phase Reviews and Design Reviews.
• Partner with R&D to determine and define design inputs, design outputs, and design input/output relationships.
• Create and support the development and validation of new test methods.
• Determine and document risks associated with the product (Hazard Analysis, DFMEA, PFMEA, UFMEA).
• Develop the strategy and manage the execution of design verification and validation.
• Generate test protocols, manage test execution, investigate test issues, analyze data, and create reports for design verification and validation testing.
• Develop, execute, and manage First Article inspections.
• Support regulatory approvals and responses to regulatory questions.
• Support Sustaining Engineering for design and process changes to commercialized product.
• Provide direction to design assurance engineering technicians supporting assigned projects.
• Review and improve Design Assurance specific quality system deliverables and processes to increase effectivity and efficiency.
• Support the transfer of new product development projects from development to production.
• Support internal and external audits.
• Systems Engineering for complex electrical/mechanical devices.
• Experience with software verification/validation execution.

Education / Experience Requirements

• BA/BS in Engineering or physical sciences required.
• Five years of related experience required.

Specialized Skills / Other Requirements

• Ability to work independently and with minimal direction.
• Ability to define, organize, and manage individual and team tasks.
• Provide direction to extended and core team members.
• Effective verbal and written communication.
• Proficient in technical report writing and review.
• Interpersonal skills; working in a team and as an individual contributor.
• Structured and methodical problem-solving approach.
• Strong understanding of design controls, risk management, statistics, test method validation, and new product development processes.
• Strong understanding of industry regulations such as ISO13485 and FDA QSR's.
• Foster a positive culture of growth, collaboration, and achievement across the organization.
• Experience with IEC 60601-1 series of standards and IEC 62304

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® - trusted brands united by a common sense of purpose.Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

© 2021Teleflex Incorporated. All rights reserved.


Job Alerts

Provide an email, zip code for jobs, and/or job category to subscribe to job alerts. Learn more now.


*By subscribing, you agree to our Terms and Privacy Policy.

More Sales jobs


Waste Industries
Harrison, Michigan
Posted about 7 hours ago
Waste Industries
Traverse City, Michigan
Posted about 7 hours ago
Waste Industries
Elmira, Michigan
Posted about 7 hours ago
View Sales jobs »

New post from our employment blog

Top 5 Red Flag Signs to Look Out for in Your Job Search

Are you on the hunt for a new job? As of May, there are about

Read blog post
Share this inclusion job with the community

Click a community link below, and then social share the Sr. Design Assurance Systems Engineer, MDR job.


Disability inclusion jobs logo
Asian inclusion jobs logo
Black inclusion jobs logo
Diversity inclusion jobs logo
LGBTQ inclusion jobs logo
Seniors inclusion jobs logo
Women inclusion jobs logo
Hispanic inclusion jobs logo