San Diego, CA
IT PM, PMP, MS Project, PMBOK, FDA, ISO, KPIs, software integration, software releases,
Seeking a Senior Technical Project Manager for our innovative client located in San Diego, CA. This is a 9-month W2 contract position. Work will start on a remote basis and will transition to hybrid remote/onsite or onsite once the team returns to the offices.
The purpose of this role is to drive project execution and design changes within the On Market Portfolio. Candidates will benefit from a strong understanding of product development processes, as well as managing quality investigations. Multi-disciplinary knowledge is ideal including knowledge in software and arrays.
The successful candidate must be able to work independently, handle multiple projects in parallel, and communicate effectively across all levels of the organization.
• Requires a Bachelor’s degree in a scientific discipline or engineering with 5+ years of product development experience in a regulated industry with 4 years as a Project Manager
• Typically requires a current PMP certification
• Expert at project scheduling using MS Project, Office Timeline Plus including dependencies and critical path determination and optimization
• Accomplished at resource scheduling and loading.
• Understands product development lifecycles and on-market management of products.
• Able to communicate effectively at most levels of the organization.
• Command of many topics in the PM Body Of Knowledge (PMBOK)
• Familiar with genetic sequencing principles and sequencing devices and applications.
• Familiar with FDA and CE-IVD regulated product development and post-market processes.
Able to work independently, receiving little to no instruction on day-to-day work.
• Consistently demonstrates advanced maturity and emotional intelligence.
• Lead and/or support projects across platform management teams
• Lead the project planning activities including definition of scope, identification of key task and production of detailed timelines with durations, dependencies, critical path, and milestones.
• Engage the teams to determine project risks and develop mitigation plans.
• Track and report on project success KPIs.
• Develop project effectiveness check plans and monitor in conjunction with leadership.
• Present project plans to senior management and provide regular updates throughout the project management lifecycle to effectively manage expectations of progress against planned commitments.
• Drive continuous improvement initiatives to advance portfolio capabilities including driving continuous improvement within the program management team.
• Network with internal personnel in a matrixed organization to balance priorities and optimize execution
• Apply best practices and knowledge of internal/external business challenges to improve products
• Working knowledge of leading software development projects (SW Releases, SW Environment management, SaaS, SW Integration projects) using standard methodologies (SCRUM, SAFe, Kanban, waterfall, hybrid etc.)
• Advanced use of project management tools including Microsoft Project and/or Office Timeline Plus
• Experience working in a regulated environment and familiar with Design Controls for the development of medical devices such as 21CFR820, ISO 13485, and ISO 14971
• Work knowledge of R&D, Manufacturing, and Software Development from direct or project related experiences
• The successful candidate must be able to work independently, handle multiple projects in parallel, and communicate effectively with all levels of the organization. Demonstrates good judgment in selecting appropriate methods and techniques for obtaining solutions
• Ability to negotiate and influence cross-functionally.
• Adaptable to fast-paced, dynamic work environment and shifting demands. May have early morning or late meetings as this person will be working with teams in different time zones.
• Extremely strong communication, interpersonal skills and customer focus.
• Strong leadership skills with demonstrated ability to effectively work across teams and functions.
For more information, please email: Jobfirstname.lastname@example.org.