Sr. Design Assurance Engineer — Hardware​/Software

Expected Travel
:
Up to 25%

Requisition : 105

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

Built on a history of innovation, our Arrow® brand of technically advanced vascular access devices are renowned throughout the world. Many of our vascular access products have antimicrobial and antithrombogenic protection designed to reduce vascular‑related complications and include long and short dwell central venous catheters (CVC), sheath introducers, arterial lines, peripherally inserted central catheters (PICC), as well as specialty devices for intraosseous vascular access and an advanced vascular positioning system to facilitate precise placement of a PICC or CVC near the heart.

Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

• Fulfill hardware and software design assurance role on new product development (conception to launch) and sustaining projects.
• Contribute to planning and execution of design controls, risk management, test method development and validation, design verification/validation, and process qualification for new and existing products.
• Support Regulatory Affairs with creating submissions and responding to submission questions.
• Ensure quality and compliance of design for both New Product Development and Sustaining Engineering.
• Develop, document, and optimize new product development deliverables and processes, accounting for cross functional system interactions.

• Contribute to new product development Technical Reviews and Design Reviews.
• Apply modern, iterative software design processes and development practices.
• Understand product user needs and assure they are translated to the design, while ensuring compliance to usability and human factors standards and regulations.
• 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 and maintain the product risk management file, including updating based on post‑market information.
• Perform cybersecurity risk analysis including implementing testing and controls to mitigate risks.
• 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 test strategies, test plans and test procedures for software platforms including embedded and real‑time Operating Systems (OS).
• Apply requirements management, version control, and issue tracking tools.
• Understand and assist in applying supplier management principles such as supplier selection, qualification, certification, and performance improvement.
• Support regulatory approvals and responses to regulatory questions.
• Assure quality of the Sustaining Engineering process for design and process changes to commercialized product.
• Review and improve Design Assurance‑specific quality system deliverables and processes to increase effectivity and efficiency.
• Assure quality in the transfer of new product development projects from development to production. Assist with process validations and control plans.
• Produce Design History File (DHF) and Device Master Record (DMR) documentation per quality system requirements.
• Lead or support investigations of product…