<p>JOB SUMMARY- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.</p> <p>The Sr R&D Engineer is responsible for leading the technical aspects for our commercialized Interventional Devices product portfolio. This role is focused on sustaining engineering efforts to ensure continued performance, compliance, and customer satisfaction. Key responsibilities include design maintenance, risk management, and cross functional support for quality, regulatory and supply chain issues.</p> <p>Essential Duties and Responsibilities</p> <ul> <li> <p>Serve as the technical lead for sustaining engineering and marketing support activities related to our Interventional Devices portfolio</p> </li><li> <p>Own and execute design updates, engineering assessments, and documentation revisions in accordance with quality and regulatory standards</p> </li><li> <p>Collaborate with cross-functional teams (Quality, Regulatory, Manufacturing, Supply Chain) to address product issues, resolve complaints, and manage component obsolesces</p> </li><li> <p>Complies and analyzes, operational, test and research data to establish technical specifications for designing or modifying products, processes and materials</p> </li><li> <p>Successfully completes complex engineering work in one or more of the following: technology development, product design and development, test of materials or products, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation</p> </li><li> <p>Use fundamental PD/DFM tools to reduce variation and achieve capable processes with high production yields where required</p> </li><li> <p>Perform process optimization through DOEs, DCMs and process capability studies, as required</p> </li><li> <p>Selects techniques to solve complex problems and make sound design recommendations</p> </li><li> <p>Summarizes, analyzes and draws conclusions from complex test results</p> </li><li> <p>Designs and prepares complex reports to communicate results to technical community</p> </li><li> <p>Designs and coordinates complex engineering tests and experiments</p> </li><li> <p>Interfaces with Physicians/Cath Lab personnel to obtain feedback on concepts and performance of devices</p> </li><li> <p>Translates customer needs into product requirements and design specifications</p> </li><li> <p>Write, execute and review validation protocols and reports when appropriate</p> </li><li> <p>Conduct test method development as required by project teams</p> </li><li> <p>Stay current with and ensure appropriate compliance with SOP's on all projects</p> </li><li> <p>Provide timely responses to the Corrective Action/Preventive Action (CAPA) program as required</p> </li><li> <p>Provide support as required to safety, ISO, FDA, corporate and internal audits</p> </li><li> <p>May perform other duties as assigned</p> </li></ul> <p>QUALIFICATIONS-The requirements listed below are representative of the knowledge, skill or ability required.</p> <p>Education and Experience</p> <ul> <li> <p>Bachelor's Level of Degree in the Engineering/Technical field of study</p> </li><li> <p>Equivalent work related experience acceptable in lieu of degree Yes No</p> </li><li> <p>8 years of demonstrated experience in Engineering or related field</p> </li><li> <p>Experience in the medical device industry</p> </li></ul> <p>Skills/Knowledge</p> <ul> <li> <p>Prior experience with SolidWorks and Minitab software a plus</p> </li><li> <p>Proven statistical analysis on product and process capabilities</p> </li><li> <p>Excellent attention to detail and documentation practices</p> </li><li> <p>Ability to manage multiple tasks in a fast-paced, compliance-driven environment</p> </li><li> <p>Proficient in the following computer software applications: Microsoft Office</p> </li><li> <p>Exceptional interpersonal skills.</p> </li><li> <p>Strong organizational skills.</p> </li><li> <p>Strong communication skills (written and verbal).</p> </li><li> <p>Ability to effectively communicate both internally and externally.</p> </li><li> <p>Ability to read and interpret documents such as safety rules, operating and maintenance, instructions, and procedure manuals. Ability to write routine reports and correspondence.</p> </li></ul>