Purpose:

‍We are currently seeking a Program Manager who will be responsible for the overall direction, coordination, implementation, execution, control, and completion of dialysis machine development projects ensuring consistency with company strategy, quality, commitments, and goals.  This is a highly visible role reporting directly to the company’s Chief Operations Officer.  The Program Manager will also have direct engagement with Diality’s CEO and other company officers on a weekly basis. 

Duties & Responsibilities:

• Lead the planning and implementation of projects by working closely with the project sponsor and cross functional teams
• Hold functional leaders accountable to maintaining milestone and deliverable commitments 
• Facilitate the definition of project plan, project scope, project schedule, project budget, milestones goals and deliverables
• Act as main contact with both internal and external stakeholders during all development phases
• Define project tasks and resource requirements
• Collaborate closely with engineering, operations, quality, regulatory, clinical, and commercial functions
• Develop full scale project plans and project budget
• 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
• Ensure and maintain development process according to ISO 13485 and FDA 21 CFR 820 requirements
• Constantly monitor and report on progress of the project to management
• Manage project risks
• Present reports defining project progress, problems, and solutions
• Document, implement and manage project changes and interventions to achieve project outputs
• Project evaluations and assessment of results

Qualification Requirements: 

• Scientific or engineering degree
• Certification in advanced project management is preferred
• Knowledge of both theoretical and practical aspects of project management
• Aptitude for conflict resolution, negotiation and creating positive outcomes
• Goal orientated, able to set, reach and exceed goals
• Creative and persistent problem solver; excellent analytical and thinking skills with a highly refined work ethic who can work independently or as part of a team.
• Results and goal oriented and driven to succeed with unquestionable integrity
• Maintains a steady focus on objectives and tasks, ability to plan and organize activities autonomously

Experience and Required Skills:

• BS/MS Engineering with ten years of experience in relevant field and similar role
• PMP and/or CSM preferred
• Proficient at using project management tools such as MS Project
• Proficient at using computer-based software for managing Agile (Scrum) projects (Jira or similar)

Knowledge & Abilities:

• 10+ years of program management experience in the life sciences industry with specific experience in medical device highly desired
• Proven experience in project estimation and budget controlling
• Proven experience in stakeholder management and setting expectations
• Proven experience in risk management
• Proven experience managing complex technical projects (medical devices preferred)
• Exceptional documentation skills
• Outstanding communication skills at all levels of an organization
• Experience in engaging cross functional leadership in engineering, manufacturing, regulatory affairs, finance, commercial 
• Excellent written and verbal communication and presentation skills with the ability to articulate ideas and concepts into practical solutions
• Highly organized, 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
• Self-confident, highly organized, detail oriented, high energy with excellent time management and planning skills.
• 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.

Physical Demands:

The employee may occasionally lift and/or move up to 40 pounds.

Working Environment:

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities.

Travel:

Ability to occasionally travel domestically

Overall Purpose:

‍In preparation for the transition from an R&D organization to a commercial enterprise, Diality will develop a Customer Service Organization to support the roll out of the company’s first product. 

The Manager of Customer Service will report to the Chief Business Officer (CBO) and be responsible for owning the development of the company’s customer service structure and overall strategy. As the company scales and grows, the dialysis industry continues to evolve with new provider models, Diality will need to develop and execute a customer service model that supports the initial commercial release of our device but also contemplates the long-term direction of the market. The Manager of customer service will lead an organization that has responsibility for supporting customers, sales and field service pertaining to Diality Dialysis System. This position is the first hire in the Customer Service Department and therefore will be responsible for not only establishing new processes and procedures but over time the recruitment, hiring, and onboarding of additional customer service staff. 

The Customer Service Manager will interface externally with our customer’s purchasing and contracts professionals and internally with Diality’s sales and marketing functions

Duties & Responsibilities:

• Together with the CBO, develop the company’s customer service strategy
• Ownership for the development of all documentation and processes to manage order fulfillment for the company hemodialysis system including both our capital and annuity revenue streams 
• Ability to recruit, onboard, train and manage customer service professionals.
• Provide direction and leadership to the customer service team.
• Ensure all customer issues are managed quickly, and the customers are happy with resolution.
• Must have basic knowledge of medical devices.
• Schedule preventative maintenance with customer and Field Service.
• Communicate customer information/needs to Sales and Field Service.
• Ability to understand and communicate customer issues and escalations.
• Provide detailed reporting on Customer Services KPI’s to CBO
• Accurately document all customer service activities.
• Self-starter with the ability to multi-task and re-prioritize duties throughout the day.
• Excellent communication skills with the ability to interact with customers, patients, and internal personnel.
• Manage and maintain company assets required to perform all necessary job functions.

Qualification Requirements: 

• Bachelor’s degree or military equivalent.
• 7+ years Customer Service experience in the Medical Equipment Industry preferred with at least 3+ years managing others 
• Must have valid driver’s license and good driving record.

Experience and Required Skills:

• Previous experience in building Customer Service Departments within the medical device industry is a requirement for this role 
• Visionary leader who can operate at all levels within the organization from the C-Suite down to the customer and patient 
• Self-Starter with the ability to understand the right level of process and structure needed for a growing medical device organization at the right time

Knowledge & Abilities:

• Ability to respond in verbal or written form (email) to inquiries or complaints from customers or co-workers.
• Excellent computer and technology skills with regards to software applications, (Excel, Word, Outlook, Power Point) ERP databases, and technology innovation.

Physical Demands:

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 most 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:

This position primarily works in an office environment. It requires frequent sitting, standing, and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities.

Travel:

Ability to travel domestically as needed