Medical Device Software Project Manager

My client is a $25 billion company in the medical device industry. They are in need of a Project Manager for software development inside medical devices. If you are a fit, please call KELLY at to discuss.How will you make an impact?As Software Project Manager for Genetic Testing Solutions, you will ensure that software projects run on schedule, meet scope and requirements, and that all software activities and tasks are completed in accordance with design compliance in an FDA regulated environment. The role involves attending core team meetings; coordinating with project team members outside of the software group; preparing, maintaining and overseeing software plans and report documentation; resource planning and management; and resolution of issues that arise throughout the software development cycle. You'll coordinate all software activities to ensure timely completion, overcome obstacles, and mitigate identified risks.Ideally, the project lead will possess a deep understanding of qPCR and IVD genetic testing workflows in a clinical laboratory. This role will provide leadership and guidance to the software engineering team to ensure the highest quality standard of product in an FDA-regulated environment.What will you do?• Collaborate with product management and key stakeholders to define the scope of each software release, with an eye on the product development roadmap.• Plan and manage software development, testing and related activities and timelines for clinical software development projects.• Estimate overall engineering effort and collaborate with management to acquire and enable the necessary resources.• Author, review, and approve software development plans and report documentation, ensuring design compliance for clinical laboratory software.• Drive process improvement in software development and test methodologies, such as tracking software activities, project metrics reporting, and creating efficiencies.• Ensure all software activities are accomplished in accordance with FDA guidance, design compliance with internal procedures, and suitability to intended use of the clinical product.• Ensure that all projects toolsets and environments are in place for the project and are adopted and properly used by the software engineering team.• Participate in Software Hazard Analysis activities to ensure a full understanding of patient and safety risks for clinical software products.• Ensure that risk control measures are implemented correctly and verified accordingly with suitable traceability.• Collaborate with algorithm engineers to coordinate algorithm integration into the software development schedule.• Clearly communicate status of software product development to key stakeholders via status updates.• Ensure completion and delivery of trace matrix from product requirements to test case results.How will you get here?Education/ Experience• Bachelors degree and 8 years related industry experience/ Advanced degree and 6 years related industry/ Educational equivalency with additional industry experience may be considered.• B.S. in computer science or in molecular biology, biology, microbiology, biochemistry, or similar scientific discipline.• Familiarity with laboratory workflows in a clinical diagnostic environment.• Experience in new product development from product realization to product launch.• 3+ years of experience managing projects in a clinical or diagnostic laboratory setting and an FDA regulated environment.• 5+ years of experience leading software teams successfully.• Project planning and advanced computer skills a plus.• Ability to manage multiple work streams concurrently.• Experience with Jira, MS Project, DOORS Next Generation, HP ALM preferred.• Experience in Agile software development methodology preferred.• Familiarity with IEC 62304, ISO 13485, ISO 14971, ISO 9001, and 21 CFR Part 820 preferred.