Staff Engineer

SCOPE:This role will involve a range of responsibilities including but not limited to product design, prototyping and bench-testing, verification and validation test design and execution, data analysis, and root cause investigation.NOTE: Candidates must be local the Boston, MA area and be able to adhere to our hybrid policy, which is currently 3 days/week in office and 2 days/week remote.PRIMARY RESPONSIBILITIES:Utilize multidisciplinary engineering knowledge and experience to design and develop new productsSupport medical, scientific, regulatory, manufacturing, marketing, and sales in product research, technology, and designSupport design projects for established products targeted to add value, stay current with regulatory requirements, and proactively pre-empt obsolescencePlan, schedule and coordinate project tasks and activitiesUtilize structured problem-solving approaches to resolve design investigations during development or for on-market productsConceive and build working prototypesRun empirical and experimental analysis utilizing various analytical design toolsWork with outside consultants, suppliers, and customers (including clinicians)Perform Tolerance Analyses of complex assemblies Support bench / animal testing and clinical evaluationsEstablish product requirements and specificationsEstablish test method and model developmentGenerate required documentation including timelines, budgets, specifications, testing protocols, design verification protocols and risk analysisIdentify and mitigate project risksAssist in coordinating the design control system and assure complete compliance with all requirementsPrepare documentation for regulatory submissions and internal quality systemDevelop/coordinate efficient manufacturing processes with third parties as neededCollaborate on pre-clinical, human factors, and human studiesEnsure compliance with procedural and documentation requirements of Sirtex Global, FDA, ISO and other regulatory bodies