Job TitleSkills MatrixSkill - Last Used - Experience in Years/month - Rating (10 points)1 = newbie 10 = expert - Hands on Exp.Yes/NoJAMAMedical devicesFDASaaSAgileKey Responsibilities-Collaborates with the agile team to translate the business vision into language that can be consumed by development resources.Develop and manage the software design history fileSupport Project Documentation and Materials needs via SAPMaintain JAMA tool and produce required documentation for the design history fileTrack project performance, specifically to analyze the successful completion of short- and long-term goalsMeet budgetary objectives and make adjustments to project constraints based on financial analysisDevelop comprehensive project plans to be shared with management as well as other staff membersCollaborates with team in identifying workflow and process gaps and issuesAssists in backlog grooming and maintenanceOrganize and conduct reviews with stakeholders and development teamsCoordinate cross-functional reporting across teams - ensuring inter-dependencies are documented, understood, and communicated.Use and continually develop leadership skillsJob Qualifications-Bachelor's Degree in Engineering/TechnologySelf-reliant; takes initiative; results-oriented; collaborativeCapable of managing time and project assignments with minimal oversightAbility to meet tight deadlines in an environment of competing prioritiesProven commitment to proactive planning, thoroughness, and excellent executionWell organized, detail oriented, highly analytical, possess strong problem-solving skills and must have a desire to be accountable for project successExcellent team-work and coordination, professionalism and disciplineLimited travel might be required.Minimum of 1 year experience in the medical device industry as well as Medical Device Software systems and cardiovascular devices highly preferred (Class III medical device experience strongly preferred)Demonstrates knowledge of quality policies, principles and best practices and FDA/ISO requirementsA strong candidate will also have-Experience supporting FDA regulated productsProject Management Professional (PMP) CertificationExperience working with Agile development with a Continuous Discovery/Delivery mindsetExperience delivering SaaSExperience working directly with software engineers