Senior Program Manager

Diality, Inc.; Irvine (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Diality, Inc. is seeking a Senior Program Manager to coordinate, implement, and complete dialysis machine development projects aligned with company strategy and quality commitments.

You will work with engineering, operations, quality, regulatory, clinical, and commercial teams to ensure milestones, budgets, and deliverables are met. The role requires a Bachelor’s in Engineering or Science, 8–10+ years in life sciences PM, and experience guiding complex medical device programs through development

Qualifications

• Bachelor's degree in Engineering or Science related field.
• Minimum 10 years’ of related experience or 8 years and a Master’s degree.
• 8+ years of program management experience in the life sciences industry with specific experience in medical device highly desired.

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

Skills

MS Project

Jira

Agile/Scrum

Hybrid Scrum/Waterfall

Communication

Organization

Multitasking

Self-motivation

Team collaboration

Cross-functional leadership

Education

Bachelor's degree in Engineering or Science

10+ years program management experience

PMP and/or CSM preferred

Job description

Description

Company & Job Overview

Diality is a medical device company focused on developing solutions to improve lives impacted by kidney disease. Diality offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connected hemodialysis system designed to maximize clinical flexibility and ease-of-use for both clinical and non-clinical users. The Moda-flx Hemodialysis system combines flow rate capabilities of conventional in-center dialysis devices with a fully integrated reverse osmosis (RO) water filtration system to provide a broad range of prescriptions and meet the needs of any professional dialysis care setting.

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 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.

Requirements

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 10 years’ of related experience or 8 years and a Master’s degree
• 8+ years of program 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

• Sustained periods of time standing and sitting in a laboratory
• Sitting at a desk utilizing a computer
• Some lifting of<25 pounds

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.