Senior Project Manager

Senior Project Manager

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. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems.

We are currently seeking a Senior Project Manager who will be responsible for the coordination, implementation, execution, control, and completion of dialysis machine development projects ensuring consistency with company strategy, quality, commitments, and goals.

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

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Individuals will be required to 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.

The information contained in this job description is for compliance with the Americans with Disabilities Act (ADA) and is not an exhaustive list of duties performed for this position.