Product Quality Assurance Engineer at Eko

Emeryville, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Digital HealthIndustries

Requirements

Bachelor’s degree in engineering (or related field)
Experience in the medical device industry regulated by ISO 13485 and 21 CFR 820
Experience with products containing both hardware and software aspects
Hybrid role with required onsite presence on Tue/Wed/Thu

Responsibilities

Support new product development and sustaining engineering to ensure products are designed, developed, and maintained in compliance with industry regulations and internal standards
Act as the QA point of contact and Subject Matter Expert (SME) for validation and Quality Risk Management activities related to assigned products/systems
Write, review, and approve validation documents, including Validation Plans, Functional Risk Assessments, Application Design or Configuration Specifications, Test Scripts, and other appropriate documents
Perform GxP-related activities in alignment with business requirements and ensure compliance with applicable regulations
Maintain up-to-date knowledge of industry standards, regulations, and best practices related to quality management, and implement changes as necessary
Facilitate development and maintenance of product design documents, including design inputs, product requirements specifications, design output documents, DMR, DHF, and design traceability matrices
Support risk management activities to maintain a comprehensive product risk management file, including product hazard analysis/FMEA, use error analysis, and risk management reports
Lead product-specific quality system activities and processes per ISO 13485, including complaint handling, CAPA investigations, supplier evaluations, training development and management
Collaborate with internal teams to identify and implement improvements to quality management processes and ensure internal SOPs comply with applicable international and local regulations
Partner with cross-functional groups to ensure audit-readiness across the quality management system, including complaints/feedback, CAPA/NC closures, internal audit planning/execution, and supplier evaluation/approval
Follow and maintain Quality Management System processes to support product development in compliance with international and US medical device regulations
Drive completion of key design control, risk management, and change control deliverables for new product development and current on-market products

Skills

ISO 13485

21 CFR 820

Quality Management System

Design Control

Risk Management

Change Control

CAPA

Internal Audit

Supplier Evaluation

Medical Device Regulations

Eko

Advanced digital stethoscopes for cardiovascular detection

About Eko

Eko Health specializes in advanced medical devices and software that enhance the detection of cardiovascular diseases. Their main product is an electronic digital stethoscope that integrates with AI-powered software to help healthcare professionals identify heart conditions more accurately. The stethoscopes feature Bluetooth connectivity, noise cancellation, and amplification, allowing clinicians to listen wirelessly and clearly. The AI software automatically checks for signs of heart disease, such as atrial fibrillation and heart murmurs, providing reliable results without interrupting the examination process. Eko Health differentiates itself from competitors by combining traditional stethoscope functionality with modern digital enhancements and leveraging a large dataset of real-life heart sounds to train its AI for accurate detection. The company's goal is to improve early detection and timely intervention in heart and lung diseases, ultimately leading to better patient outcomes.

Oakland, CaliforniaHeadquarters

2013Year Founded

$227.8MTotal Funding

SERIES_DCompany Stage

AI & Machine Learning, Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Paid-time off

Medical/Dental/Vision, Disability + Life Insurance

Volunteer time off

One Medical membership

Parental Leave

401(k) Matching

Work from home equipment stipend

Flexible schedules

Wellness programs (Wellness Wednesdays, Time off)

Wellness perks (Headspace, Ginger, Aaptiv, Physera)

Learning and Development stipend

Risks

Competition from Astellas Pharma's DIGITIVA may impact Eko's market share.

CPT code issuance may delay reimbursement, affecting short-term revenue.

Scaling partnerships like LSU Athletics may face challenges, limiting expansion.

Differentiation

Eko Health integrates AI with digital stethoscopes for enhanced cardiac care.

Their platform is FDA-cleared, ensuring high reliability and trust among clinicians.

Eko leverages the largest dataset of heart sounds for accurate AI training.

Upsides

Eko's partnership with LSU Athletics expands AI use in sports medicine.

The AMA's CPT code issuance boosts potential reimbursement for Eko's SENSORA platform.

Recent $41 million funding round indicates strong investor confidence in Eko.

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