Staff Engineer, Product Development

Enable Injections develops and manufactures on-body delivery systems designed to improve the patient experience. QUALIFICATIONSRequiredBachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or related engineering field from an accredited universityA minimum of 8 years of product development experience; OR master’s degree plus 6 years experiencePreferredAdvanced Engineering DegreeExperience in developing and commercializing regulated medical devicesExperience coordinating and driving cross-functional product development teamsExperience in root cause investigation and failure analysisExperience in project planning/scheduling and self-regulated time managementExperience with plastic injection-molded part design, assembly and fabrication methods, and plastic material properties (resins and silicones)Experience with designing for large scale automationKnowledge of global industry standards (ex. ISO, AAMI, ANSI, etc.)Skills & CompetenciesProficiency in mechanical design fundamentals, solid modeling, tolerance stack analysis, design for manufacturing and assembly, Geometric Dimensioning and Tolerancing (GD&T), and statistical analysisStrong analytical and demonstrated problem-solving skillsExcellent verbal communication, technical writing, and presentation skillsDemonstrated ability to prioritize tasks and lead a varied workload to meet departmental and company objectivesWorking knowledge in FDA, CE Regulatory, and/or Design Control processesDemonstrated technical coaching and leadership of peersStrong cross functional internal leadership, communication, influencing and negotiating skillsCompetent with SolidWorks softwareProficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Outlook)Physical RequirementsMust be able to remain in a stationary position for extended periods of timeAbility to operate a computer and other office equipment, such as printer, telephone, etc. ResponsibilitiesLead the design and development of medical device products and components that adhere to company procedures, industry regulations, and customer standardsSignificantly contribute to the development of new designs and/or processes at all stages, from concept creation to launched productApply mechanical engineering principles and techniques to solve challenges related to product design, manufacturing, assembly, and testingConvert user needs to design inputs and develop statistically sound design verification and validation strategiesDevelop and review models, drawings, specifications, test protocols, engineering reports, and other associated engineering documentationPromote visibility and transparency of information within product development and other forums to accelerate decision making, obtain alignment, and increase foundational knowledgeProvide technical guidance and coaching of other engineersSupport project strategies that match Enable product and pharmaceutical partner goalsWork with functional managers and project management leaders to contribute to internal project planning and execution to ensure company goals are metAssist to establish and maintain detailed project plans including defining risks through comprehensive mitigation assessment and planning techniquesProvide project and technical communication to cross functional teams for devices through clinical development, product registration and commercializationUnderstand and follow the New Product Development process with a focus on qualityEnsure accurate and controlled documents are generatedAssist in nonconformance, complaint, and failure investigationsDesign test fixturing and methods to assess design feasibility and performance limitsIdentify and communicate product and Product Development related objectives, issues, and risks and facilitate interdepartmental and cross functional discussion on impactsSupport strong collaborative relationships with external design and manufacturing partners and service providersEnjoy a collaborative and innovative culture with competitive pay and full benefits package.