Senior Project Manager

Company & Job Overview

Diality Inc, a privately held medical device company located in Irvine, CA, is committed to improving the quality of life for patients with kidney disease. They are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel.

Responsibilities

• Lead the planning and implementation of projects by working closely with the project sponsor and cross-functional teams.
• Hold functional team members accountable to maintaining milestones and deliverable commitments.
• Facilitate and control the definition of project plan, project scope, project schedule, project budget, milestones goals and deliverables.
• Define project tasks and resource requirements.
• Collaborate closely with engineering, operations, quality, regulatory, clinical, and commercial functions.
• Monitor and report project staff, budget, and resources allocation.
• Plan and schedule project timelines
• Track project deliverables using appropriate tools and metrics.
• Provide leadership, direction, and support to project team.
• Constantly monitor and report on progress of the project to management
• Present reports defining project progress, problems, and solutions.
• Document, implement and manage project changes and interventions to achieve project outputs
• Provides solutions to various issues in creative and effective ways.
• Directs the application of existing principles and guides development of new policies and ideas within the function.
• Understands and works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Exhibits advanced wide-ranging experience, using in-depth professional knowledge, acumen, concepts, and company objectives to develop, resolve complex models and procedures.

Required Skills & Abilities

• Proficient at using project management tools such as MS Project
• Proficient at using computer-based software for managing Agile (Scrum) projects (Jira or similar)
• Ability to operate autonomously while running one to multiple new product development projects
• Familiarity with hybrid Scrum/Waterfall Project Execution
• Excellent written and verbal communication and presentation skills with the ability to articulate ideas and concepts into practical solutions.
• Highly organized/detail oriented, excellent follow through and follow up skills, results, and delivery oriented.
• Able to multi-task a variety of duties and work requests
• Self-motivated and works well under pressure with changing priorities and a workload.
• Team player with very good collaboration skills, fostering knowledge sharing with team members.
• Demonstrated positive interpersonal skills with the flexibility and adaptability to relate to and collaborate with people at all levels of organization and work well with a diverse employee group.
• Positive attitude and desire to succeed.

Education & Experience

• Bachelor’s degree in Engineering or Science related field
• Minimum 7 years’ of related experience or 5 years and a Master’s degree
• 4+ years of project management experience in the life sciences industry with specific experience in medical device highly desired.
• Proven experience taking a project through scoping and requirements identification through production release.
• Proven experience in stakeholder management and setting expectations.
• Proven experience managing complex technical projects in a medical device space
• Experience in engaging cross functional leadership in engineering, manufacturing, regulatory affairs, finance, commercial.
• PMP and/or CSM preferred

Travel

Willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attendance at select conferences.

Physical Requirements

• Sit for the majority of the day and will be required to stand as needed.
• May require walking, primarily on a level surface for periods of time throughout the day.
• The employee is occasionally required to stand, walk, climb or balance, stoop, kneel, crouch or crawl and talk or hear.
• Proper lifting techniques will be required to lift up to 75lbs.
• Individuals will be required to travel via airplane, train, taxi, car and/or other means of transportation as needed.

Working Environment

Typical office areas with offices, cubicles and conference rooms.