Sr. Program Manager/ENG Product Development

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. 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 Program 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 for maintaining milestones and deliverable commitments.
• Facilitate and control the definition of the 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 resource allocation.
• Plan and schedule project timelines
• Track project deliverables using appropriate tools and metrics.
• Provide leadership, direction, and support to the project team.
• Constantly monitor and report on the 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 the 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, and resolve complex models and procedures.

Qualifications & Requirements:

• Bachelor’s degree in Engineering or Science related field
• Medical Device experience required
• Minimum 8 years of related experience or 6 years and a Master’s degree
• 5 years of program management experience in the life sciences industry with specific experience in medical devices highly desired.
• 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
• 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
• Familiarity with hybrid Scrum/Waterfall Project Execution
• Experience in engaging cross-functional leadership in engineering, manufacturing, regulatory affairs, finance, and commercial.
• 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 the organization and work well with a diverse employee group.
• Positive attitude and desire to succeed.
• PMP and/or CSM preferred