Engineer 2, Sustaining, R&D

Teleflex; False Pass (AK); On-site; USD 90,000 - 120,000; Full time

Job summary

The Engineer 2, Sustaining, is responsible for supporting the ongoing lifecycle management of vascular access devices, ensuring product quality, regulatory compliance, and manufacturing efficiency.

This role focuses on analyzing design changes, conducting verification and validation activities, and collaborating with cross‑functional teams to implement product improvements while maintaining alignment with business objectives and industry regulations.

Responsibilities

• Assist in analyzing design changes to vascular access devices.
• Support verification and validation activities (IQ, OQ, PQ).
• Conduct risk analyses (DFMEA, UFMEA) and assist CAPA efforts.
• Update DHF/DMR documentation to ISO 13485 and FDA 21 CFR 820 standards.
• Collaborate with manufacturing to improve process efficiency and scalability.
• Provide technical input for regulatory labeling and change controls.

Skills

Analytical thinking

Regulatory compliance

Cross-functional collaboration

Tools

SAP

Agile PLM

Job description

Engineer 2, Sustaining, R&D

Date: Aug 2, 2026

Location: Wyomissing, PA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 13920

About Teleflex Incorporated

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck - trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.

Vascular & Emergency Medicine

Built on a legacy of innovation and clinical excellence, the Vascular & Emergency Medicine business at Teleflex develops and delivers advanced medical technologies that empower clinicians to help improve patient outcomes and optimize healthcare efficiency. Our trusted Arrow, Arrow, EZ-IO, and QuikClot brands set the standard for vascular access and emergency medicine, offering proven solutions to enhance patient outcomes. From technically advanced vascular access devices - including central venous and arterial catheters, PICCs, and sheath introducers with antimicrobial protection-to life-saving intraosseous access systems and hemostatic technologies used by hospitals, EMS, and military teams worldwide, our portfolio embodies precision, reliability, and performance. As part of a high‑performing, purpose‑driven organization, we are united by a commitment to clinical differentiation, innovation, and excellence. Join a dynamic, growth‑focused team that offers advanced medical technology solutions that make a lasting impact on healthcare.

Position Summary

The Engineer 2, Sustaining, is responsible for supporting the ongoing lifecycle management of vascular access devices, ensuring product quality, regulatory compliance, and manufacturing efficiency. This role focuses on analyzing design changes, conducting verification and validation activities, and collaborating with cross‑functional teams to implement product improvements while maintaining alignment with business objectives and industry regulations. The engineer will work to resolve product and process issues, optimize manufacturing processes, and support design transfer activities.

Principal Responsibilities

• Assist in analyzing market segments and competitive products to understand product positioning and identify areas for improvement.
• Support product evaluations and clinical interactions to understand user needs, device applications, and clinical workflows.
• Provide engineering support for product demonstrations, basic clinician interactions, and product troubleshooting.
• Apply engineering principles to evaluate product design changes, ensuring compliance with regulatory and quality standards.
• Contribute to design verification and validation activities, including developing test protocols, executing tests, and analyzing results.
• Assist in risk management activities, including DFMEA, UFMEA, and hazard analysis, under the guidance of senior engineers.
• Support design documentation, including updating Design History Files (DHF) and Device Master Records (DMR), ensuring compliance with ISO 13485 and FDA 21 CFR 820 requirements.
• Collaborate with process development teams to ensure design outputs are compatible with manufacturing requirements and scalability.
• Participate in sustaining engineering activities such as troubleshooting product performance issues, implementing design improvements, and ensuring manufacturability.
• Work with regulatory teams to ensure product changes and updates meet compliance requirements.
• Support the execution of process validation studies (IQ, OQ, PQ) and contribute to process control improvements.
• Assist in root cause analysis, CAPA (Corrective and Preventive Actions), and non‑conformance resolution efforts.
• Develop familiarity with SAP, Agile PLM, and quality systems to support engineering changes, product tracking, and documentation management.
• Engage in technical report writing, including summarizing test data, engineering analysis, and change justifications.
• Contribute to product labeling verification, documentation updates, and engineering change requests (ECRs) as part of sustaining efforts.
• Collaborate with supply chain and operations teams to ensure smooth implementation of design changes and material substitutions.
• Participate in technical discussions, cross‑functional meetings, and project team collaborations to support business objectives.