Sr Product Development Engineer--Interventional Devices (Hybrid)
AngioDynamics
Marlborough, MA
Permanent
Full-time
27 days ago
JOB SUMMARY– To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.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.Essential Duties and ResponsibilitiesServe as the technical lead for sustaining engineering and marketing support activities related to our Interventional Devices portfolioOwn and execute design updates, engineering assessments, and documentation revisions in accordance with quality and regulatory standardsCollaborate with cross-functional teams (Quality, Regulatory, Manufacturing, Supply Chain) to address product issues, resolve complaints, and manage component obsolescesComplies and analyzes, operational, test and research data to establish technical specifications for designing or modifying products, processes and materialsSuccessfully 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 preparationUse fundamental PD/DFM tools to reduce variation and achieve capable processes with high production yields where requiredPerform process optimization through DOEs, DCMs and process capability studies, as requiredSelects techniques to solve complex problems and make sound design recommendationsSummarizes, analyzes and draws conclusions from complex test resultsDesigns and prepares complex reports to communicate results to technical communityDesigns and coordinates complex engineering tests and experimentsInterfaces with Physicians/Cath Lab personnel to obtain feedback on concepts and performance of devicesTranslates customer needs into product requirements and design specificationsWrite, execute and review validation protocols and reports when appropriateConduct test method development as required by project teamsStay current with and ensure appropriate compliance with SOP’s on all projectsProvide timely responses to the Corrective Action/Preventive Action (CAPA) program as requiredProvide support as required to safety, ISO, FDA, corporate and internal auditsMay perform other duties as assignedQUALIFICATIONS–The requirements listed below are representative of the knowledge, skill or ability required.Education and ExperienceBachelor’s Level of Degree in the Engineering/Technical field of studyEquivalent work related experience acceptable in lieu of degree Yes No8 years of demonstrated experience in Engineering or related field
Experience in the medical device industry
Skills/KnowledgePrior experience with SolidWorks and Minitab software a plusProven statistical analysis on product and process capabilitiesExcellent attention to detail and documentation practicesAbility to manage multiple tasks in a fast-paced, compliance-driven environmentProficient in the following computer software applications: Microsoft OfficeExceptional interpersonal skills.Strong organizational skills.Strong communication skills (written and verbal).Ability to effectively communicate both internally and externally.Ability to read and interpret documents such as safety rules, operating and maintenance, instructions, and procedure manuals. Ability to write routine reports and correspondence.