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Software Engineer IV

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Overall Purpose:

We are currently seeking a Software Engineer IV | Embedded/C/CAN for our Irvine, CA office. This position is primarily responsible for the design and implementation of firmware that controls pumps, valves, heaters, monitor sensors, communicates with sub-assemblies and external devices and manages the workflow with UI for our product.

Duties & Responsibilities:

Development of firmware based on user needs
Test and debug firmware
Prepare design control documents
Assist in performing development testing, verification, and validation
Review system and hardware designs from a firmware perspective

Qualification Requirements:

BSc degree in Computer Science, Electrical Engineering or equivalent
Minimum 10 years (preferably 15) of experience as a firmware developer
Solid experience in C is a MUST
Solid experience with architecting and developing real-time embedded software is a MUST
Experience with firmware development using RTOS (e.g., FreeRTOS, SafeRTOS, etc.)
Experience with communication protocols in a distributed architecture (e.g., CAN Bus)
Passionate about code quality and following well-defined SDLC

Experience and Required Skills:

Experience with writing requirements and specification documents
Experience working in a fast-paced environment
Experience of Agile process and Scrum
Electrical background in addition to programming
Closed loop control (PID) and fine tuning
Experience with Python scripting
Experience interfacing with programmable logic/FPGAs a PLUS
Knowledge and experience with rules and regulations for medical device software development (IEC 62304) a PLUS)
Highly organized; good follow through and follow up; 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 workload
Team player with excellent collaboration skills, fostering knowledge sharing among team
Exceptional communication and documentation skills

Knowledge & Abilities:

Real-time Embedded, C, CAN, closed loop control (PID)

Physical Demands:

None

Working Environment:

Office

Our Joel Test Score

Do you use source control? YES.
Can you make a build in one step? YES.
Do you make daily builds? YES.
Do you have a bug database? YES.
Do you fix bugs before writing new code? YES.
Do you have an up-to-date schedule? YES.
Do you have a spec? YES.
Do programmers have quiet working conditions? Developing a medical device is a team effort, you will be co-located with people working on the same exciting project.
Do you use the best tools money can buy? We are using unit testing tool, integration testing tool, code coverage tool, and static code analysis tool in continuous integration mode.
Do you have testers? YES.
Do new candidates write code during their interview? YES.
Do you do hallway usability testing? YES.

Travel:

< 10 %

Electrical Engineer II (Electronics)

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Overall Purpose:

Identifies, analyzes, designs and implements and tests electronic hardware for medical devices, sensor, controller and communication system interfaces.

Duties & Responsibilities:

Develops electronics and electronic sub-systems targeting high-reliability medical device applications
Participates in the engineering life cycle of medical device electronics including requirements, architecture, design, implementation, modeling and simulation, verification, integration, and debug following appropriate engineering best practices and department processes.
Create schematic drawings and support PCB design, layout and routing of sub-assemblies and systems
Apply risk, failure analysis, and root cause analysis as required within the engineering discipline
Diagnoses and proposes solutions for electrical system issues
Test and verifies electrical designs
Provides solutions for production pre and post validation
Produces and reviews BOMs
Prepares design documentation and participates-in design review.
Implements required medical product design control processes as part of electronics development.
Executes tasks and provides timely status input to project or team lead.

Qualification Requirements:

At least 4 years of relevant design experience
Bachelors of Science (or Master’s) in Electrical Engineering

Experience and Required Skills:

Electronic development CAD tools (schematic capture, layout) – Altium
Experience with microcontroller and FPGA based designs
Experience with serial data communication (SPI, I2C, UART, etc)
Experience with power electronics (SMPS, battery charger, motor drivers, etc)
Experience with data acquisition (ADC, filters, amplification, etc)
Ability to diagnose electrical problems and offer solutions
Medical Device experience preferred
Experience with electronic lab equipment
Good written and verbal communication skills

Knowledge & Abilities:

Sensor implementation and communication
Microcontroller based designs
Analog and digital circuit design
PCB design and layout toolsets
Best practices for medical device electronics safety, IEC 60601-1, IEC 60601-1-2
Show high initiative, be self-motivated, and have ability to act independently on technical matters

Physical Demands:

Standing for periods of time
Lifting equipment up to 40 lbs.

Working Environment:

Office and Laboratory

Travel:

Up to 5%

Marketing Manager

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Overall Purpose:

Reporting to the Diality Marketing Director but working directly with the CBO and other Diality executives, the Marketing Manager position is responsible for marketing Diality’s hemodialysis system upon market entry. In this role, you will be responsible for creating, developing, and managing new customer acquisition campaigns. You will be the common thread between our product development and sales organization to ensure that the voice of the customer is at the forefront of all that we do.

Duties & Responsibilities:

Collaborate with management, brand/digital marketing resources, and the sales team to develop a structures sales process capital placement to maximum patient utilization
Build, implement and optimize a lifecycle marketing strategy that informs product enhancements and future product development of the Diality platform
Develop product content strategy and work cross-functionally to develop sales enablement documentation, sales collateral, case studies, product videos, website copy, and blog posts, among other types of content that clearly articulate the benefits of Diality’s digital platform to providers, physicians, and patients
Develop and test positioning and messaging across customer audiences in various care settings – in-center, acute and ultimately the home
Collaborate with sales representatives for business development opportunities with different patient coalitions or trade associations
Establish metrics, KPIs and dashboard to provide insights in order to assess the effectiveness of campaigns and identify opportunities to improve
Candidate will ideally have competitive intel in the dialysis and/or diabetes management markets
Generate creative growth strategies while executing on the tactics
Partner with Marketing Director and Sales team to accelerate sales and device utilization

Qualification Requirements:

Who you are:

Bachelor’s degree in Marketing, Sales, or related business or scientific field
5 years of marketing, business, sales, or related business experience in the medical device industry

Desired:

Experience in dialysis and or diabetes management
5+ years of B2B marketing experience, including 3+ years in growth or product marketing with a strong focus on building brand awareness and generating qualified leads
Experience in marketing to healthcare economic models
You have the ability to personally deliver, hold stakeholders and vendors accountable and toggle between high level strategic direction, planning and the details to execution

Experience and Required Skills:

Ability to work and thrive in a fast-paced, high growth and at times unstructured work environment
Excellent communicator and creative thinker with a bias to inbox zero
You are intellectually curious with strong analytical skills
Familiarity with Salesforce and/or Microsoft Dynamics
Experience with qualitative and quantitative market research
Experience working with R&D teams to create customer and marketing requirements

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 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:

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 50% travel domestically as needed

Quality Engineer III

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‍Overall Purpose:

The Quality Engineer will play a lead role in coordinating quality assurance activities intended to ensure effective product quality processes are in place and executed throughout the lifecycle of Diality’s products. Involved in product development teams and other activities to support design controls and design transfer. Involved with product manufacturing and Supplier management activities related to quality processes in order to ensure compliance applicable requirements and standards. Will be considered a subject matter expert (SME) on Quality matters, relevant Quality tools and will work on complex problems and projects. This position is also responsible for supporting Regulatory submissions (i.e., 510k, etc.).

Duties & Responsibilities:

Coordinate attention to customer complaints, corrective actions, Medical Device Reports (MDRs) and product recalls. Responsible for bringing on-market product issues to closure and escalating to senior management for support as necessary.
Key member of the product development team representing the Quality function. Steer and support the design control aspects of product quality, program management, and quality planning from product design through manufacturing.
Supports regulatory submissions, notifications, and registrations.
Utilize wide variety of data sources including product review, complaints, manufacturing, and product quality data to identify statistically significant trends and risks.
Conduct internal and external (e.g., supplier) Quality compliance audits. Reports results and recommendations for changes as required. Confirms acceptable follow up action on audits.

Qualification Requirements:

Extensive experience and knowledge of regulatory requirements associated with Medical Device product development and Quality Management Systems (e.g., 21 CFR 820, ISO 13485, EU MDR 2017/745, etc.).
Previous experience interacting directly with FDA is required.
Product development team experience. Experience reviewing and approving technical documentation.
Broad based technical knowledge and skills in diverse areas of business (e.g., Engineering, Operations, Quality, Marketing, Clinical research etc.).
Ability to effectively negotiate and influence cross-functional stakeholders, affiliates, and Regulatory agencies are a plus.

Experience and Required Skills:

A minimum BA/BS Degree with at least 7+ years of quality engineering experience required in medical device industry.
Demonstrated experience in supporting medical device regulatory submissions and post-market activities.
Training or certification in Quality Systems Auditing preferred.

Knowledge & Abilities:

Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR regulations.
Experience maintaining risk management files per ISO 14971 requirements.
Demonstrated medical device regulatory submission experience preferred.
Excellent interpersonal skills including ability to interact with high degree of diplomacy.
Excellent problem-solving skills, applied thinking skills and technical writing skills.
Excellent communication and organization skills required.
Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
Expertise in Microsoft Office applications.

Physical Demands:

Working Environment:

Travel:

Ability to travel domestically as needed

Program Manager

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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

Manager Customer Service

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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:

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:

Travel:

Ability to travel domestically as needed

Software Engineer IV

Electrical Engineer II (Electronics)

Marketing Manager

Quality Engineer III

Program Manager

Manager Customer Service

Please apply below if you are passionate about improving the care and lives of patients with kidney disease.