Description:Your RoleYou will be responsible for supporting the overall technical direction and work for novel Acute Therapies products. Based on your technical skills, you will drive various portions of the product development cycle at stages ranging from feasibility through lifecycle management. You will review and approve design concepts/changes and provide general direction to technical staff, including ensuring that quality is built into the design during new product development and/or sustaining activities. Proactively supervising the program and developing strategies to mitigate technical risks is expected as well as reporting on the progress to senior management during routine cadence meetings.Essential Duties and ResponsibilitiesPerform the activities associated with the Systems Engineering of one or more products in different stages of the product lifecycle from new product development to post-market surveillanceUnderstand clinical and user needs and apply them to product realizationCapture inputs for Requirements from various sources such as Standards, User needs, Regulatory, Quality, Human factors, Manufacturing, Service, etc.Use knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a Systems perspectiveInitiate, develop, and lead feasibility by crafting design concepts and research methodologies that best meet both current and future customer / business needs for a product or process domain areaBuild and maintain Design History File elements and ensure traceability to requirementsFacilitate an improved understanding of the interrelationship between Requirements, Risk and ReliabilityAnticipate technical challenges and risk scenarios and then prepare, lead, and execute mitigation strategies to ensure safe and effective resultsResolve systems-related technical issues by applying problem-solving tools such as cause and effect diagrams, Pareto charts, etc.Propose and drive solutions to technical problems that are ambiguous and diverse in scopePerform impact assessments on the Requirements on an ongoing basis for any proposed design/material/process change or an observation in the field/service or manufacturing to determine the impact and need for any mitigations, then propose recommended mitigations with the rationaleInfluence partners and multi-functional team members within the projectDrive consistency to FDA, ISO and IEC design control procedures, regulations and standardsUse various software tools and programs (e.g. DOORS) to complete the above responsibilitiesTeach and mentor others in life cycle management methodologiesQualifications, Education and/or ExperienceA Bachelor's degree in Electrical, Mechanical, Biomedical, Controls, Systems, Software or other related technical/engineering field3+ years of industry work experienceMust possess sound knowledge of systems engineering and related areas such as electro-mechanical and software engineeringA demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products such as military hardwareDemonstrated strong analytical and problem-solving skillsSuccess in working with multi-functional, global teamsExcellent interpersonal/communication/influencing skillsNotes:Shift - -1This is a hybrid role VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status
Description:Your RoleYou will be responsible for supporting the overall technical direction and work for novel Acute Therapies products. Based on your technical skills, you will drive various portions of the product development cycle at stages ranging from feasibility through lifecycle management. You will review and approve design concepts/changes and provide general direction to technical staff, including ensuring that quality is built into the design during new product development and/or sustaining activities. Proactively supervising the program and developing strategies to mitigate technical risks is expected as well as reporting on the progress to senior management during routine cadence meetings.Essential Duties and ResponsibilitiesPerform the activities associated with the Systems Engineering of one or more products in different stages of the product lifecycle from new product development to post-market surveillanceUnderstand clinical and user needs and apply them to product realizationCapture inputs for Requirements from various sources such as Standards, User needs, Regulatory, Quality, Human factors, Manufacturing, Service, etc.Use knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a Systems perspectiveInitiate, develop, and lead feasibility by crafting design concepts and research methodologies that best meet both current and future customer / business needs for a product or process domain areaBuild and maintain Design History File elements and ensure traceability to requirementsFacilitate an improved understanding of the interrelationship between Requirements, Risk and ReliabilityAnticipate technical challenges and risk scenarios and then prepare, lead, and execute mitigation strategies to ensure safe and effective resultsResolve systems-related technical issues by applying problem-solving tools such as cause and effect diagrams, Pareto charts, etc.Propose and drive solutions to technical problems that are ambiguous and diverse in scopePerform impact assessments on the Requirements on an ongoing basis for any proposed design/material/process change or an observation in the field/service or manufacturing to determine the impact and need for any mitigations, then propose recommended mitigations with the rationaleInfluence partners and multi-functional team members within the projectDrive consistency to FDA, ISO and IEC design control procedures, regulations and standardsUse various software tools and programs (e.g. DOORS) to complete the above responsibilitiesTeach and mentor others in life cycle management methodologiesQualifications, Education and/or ExperienceA Bachelor's degree in Electrical, Mechanical, Biomedical, Controls, Systems, Software or other related technical/engineering field3+ years of industry work experienceMust possess sound knowledge of systems engineering and related areas such as electro-mechanical and software engineeringA demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products such as military hardwareDemonstrated strong analytical and problem-solving skillsSuccess in working with multi-functional, global teamsExcellent interpersonal/communication/influencing skillsNotes:Shift - -1This is a hybrid role
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