Job Description

Aidar Health, Inc., is a fast-growing health technology and digital medicine company with the mission to enhance the quality of life of patients with chronic conditions and enable positive health outcomes.

Aidar designs develop and deliver clinically validated breath- and saliva-based sensors and evidence-based therapeutic interventions for various chronic conditions, including heart failure, COPD, infectious disease (i.e., COVID-19), and chronic kidney disease, among many others.

Aidar has developed a revolutionary FDA-cleared medical device, MouthLab, and a cloud-based enterprise platform, which leverages proprietary AI and machine learning algorithms to create a new kind of personalized healthcare experience for chronic disease patients.

Aidar Health is looking for a Principal Systems Engineer to join our team to lead a medical device development group. Lead end-to-end device development from concept to prototype to requirements to implementation for devices that integrate a wide range of biophysical and biochemical sensors into a handheld device. The ideal candidate will have a breadth of basic knowledge in physics, and biomedical instrumentation, including analog and digital electronics, signal processing, firmware and software development, mechanical design, and physiology.

As a Principal Systems Engineer, the individual will operate in all phases and contribute to all activities of the device development and verification process. A successful candidate is self-motivated and works well both independently and in a team environment.

The position is onsite in Baltimore, Maryland.

JOB DESCRIPTION

• Lead a cross-functional team to design, develop, test, and document innovative system solutions utilizing software, hardware, and disposable components.
• Lead the definition and development of user needs, business needs, use cases, requirements, and system architecture.
• Lead the engineering analysis to optimize and select system-level concepts to ensure the final solution fulfills needs, requirements, use cases, environments, and the overall system vision.
• Coordinate with marketing and business teams to generate appropriate development goals and requirements
• Provide technical leadership along with technical and clinical procedure subject matter expertise to internal and cross-business development teams
• Develop novel ways of integrating off-the-shelf chemical and biophysical sensors into a multi-sensor platform
• Participate in building and evaluating electronic and firmware prototypes
• Design signal processing strategies and algorithms for new sensor data integration into a viable product
• Create performance, design, and architecture requirements and specifications
• Develop test methods and strategies to support early feasibility, characterization, and qualification
• Design and develop advanced new test methods, and improve existing test methods, measurement techniques, and fixtures.
• Develop unit and system-level test strategies and equipment to enable product testing for short and long-term performance and reliability
• Coordinate the multidisciplinary engineering effort toward the implementation of new systems following sound design and development methodology
• Lead documentation and oversight activities including design and development reviews, system integrations, verification, and validation testing, and management of design history files and deliverables.
• Manage and/or coordinate with a diverse set of cross-site technical contributors, including internal teams, sub-contractors, and vendors to successfully transition the system into a manufacturable design.

MINIMUM QUALIFICATIONS

• Bachelor’s or master’s degree in biomedical engineering, electrical engineering, or related discipline
• 3+ years of post-graduation engineering experience
• Experience with PCB level electronics schematic design, capture, layout, and assembly, and debugging analog and digital circuits
• Experience with managing noise and signal integrity in electronic circuits
• Experience in the full cycle of product development, manufacturing, maintenance, and documentation
• Experience with embedded software and algorithm development and fundamental signal processing
• Experience with generating requirements, design documentation, system validation, system architecture, and system integration testing.
• Experience with quality management processes.
• Excellent written, verbal, and interpersonal skills
• Strengths in collaboration, initiative, and innovation
• Strong critical thinking with effective problem-solving skills in solving new, unique, and deep technical challenges
• Holds self-accountable for delivering on commitments
• Ability to figure out what you don’t know and learn it on your own

DESIRED QUALIFICATIONS

• MS or Ph.D. in biomedical engineering, electrical engineering, or related discipline

• 5+ years of experience in medical device development and/or manufacturing

• Experience processing physiological signals (ECG, SpO2, etc.)

• Experience with writing technical documentation Experience in medical device design and manufacturing

• Experience leading a technical development

• Experience interacting with marketing/business, and manufacturing groups

• Experience with mechanical and/or electrical design, mechanical/electrical drawings, tolerance analysis, and computer-aided design (CAD)

• Experience with Bluetooth, WiFi, and LTE for data communication

• Good understanding of chemical and biophysical sensors used to capture biological signals

• Ability to read medical and engineering literature and patents

• Previous patent disclosure experience

• Experience working in a startup environment

• Experience with Electrical Safety Standards- 60601, 60601-2

• Familiarity with medical regulatory structure, CFR 21 820 FDA Quality System Regulation, GMP, GDP, ISO 13485, EU Medical Device Directives, and other applicable quality system regulatory standards

• Ability to foresee challenges and provide alternative solutions and make recommendations with engineering-based rationales

• Ability to quickly prototype new concepts and ideas

• Ability to assess new technologies via comprehensive reviews of the state-of-the-art

• Project management skills include leading a project team as well as planning and estimating tasks, milestones, resources, and budget

• Ability to drive change – including design practices and processes – throughout the organization.

• Experience working in an environment under medical device design controls

• Strong understanding of human physiology and computational biology

AIDAR’S CULTURE:

Our positive and supportive culture encourages our people to do their best work every day. We celebrate individuals by recognizing their uniqueness and offering them the flexibility to make daily choices that can help them to be healthy, centered, confident, and aware. Our culture of collaborating with each other and serving our patients (members) like our family is perhaps our biggest competitive advantage and the biggest accomplishment that we are proud of. We are continuously looking for new ways to maintain a culture where our people excel and lead healthy, happy lives.

WHY AIDAR HEALTH?

• It is a mission-driven company providing an opportunity to make a significant difference in a billion people's lives.
• Aidar is an ISO 13485:2016 and MDSAP Certified company.
• Aidar's rapid health assessment device, MouthLab is FDA 510k cleared, and CE Mark approved.
• You will have an opportunity to shape our company culture and our technical team by working with the CEO and the CTO.
• A competitive salary (competitive with industry standards and commensurate with qualifications), and other benefits.

TO APPLY:

Please send your Resume/CV to CAREERS AT AIDAR.COMwith Principal Systems Engineer in the subject line.

We are looking to hire quickly, so we will be reviewing applications on a rolling basis. Applicants are therefore encouraged to apply as soon as possible. Please note that due to the high volume of applications, we will only contact applicants selected for an interview.