Senior Design Quality Assurance Engineer

1 month ago

Palo Alto, United States Glooko Full time

This position is responsible for developing, establishing, and maintaining quality and compliance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards, agency regulations, Glooko’s Quality Policy, Quality Objectives, and Quality Manual.

About the Role:

Support and assure FDA and ISO 13485 Design Controls requirements on the development processes for Glooko products on cross-functional teams

Ensure compliance to the elements of Design Controls including Planning, Design Input, Design Output, Design Review, Design Verification, Design Validation, Design Transfer, Design Changes, and Design History File

Lead the medical device risk management activities, include FDA cybersecurity requirements, across the global organization

Facilitate the risk management and dFMEA/sFMEA processes among stakeholders in Engineering, Verification, Clinical, Product and Regulatory

Lead risk evaluation for pre-market and post-market issues for product safety, including completion of the risk documentation and the risk management file

Identify potential quality issues in products and processes and deliver guidance on developing effective remediation for addressing them

Exercise independent judgment in evaluating complex processes, procedures and systems against written regulatory requirements and company procedures

Collaborate and guide with cross-functional team members and stakeholders to ensure implementation of Design Controls and Quality Systems

Manage the change control process by monitoring all types of changes that can influence product reliability and quality

Create Quality and Risk Management Plans for product development projects and manage the plans throughout the development process

Participate in the CAPA process and work with CAPA owners to address and close CAPAs in a timely manner

Support Externals Audits from FDA, ISO 13485 and Partners including documentation and follow-up on the action items for audit issues

Support Internal Audits to document and follow-up on audit issues and assist teams with resolution of the issues

Prepare documentation required by the FDA and assist in maintaining the Glooko Quality System

About You:

BS or MS degree in Software Engineering, Biomedical Engineering, Electical Engineering, Computer Science, Regulatory Affairs or another scientific discipline

Minimum 6-8 years Quality System and Design Assurance experience in the FDA-regulated medical device industry with specific experience working directly with medical device software development teams

Direct experience with FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 62034, IEC 82304, and FDA Cybersecurity expectations

Strong understanding and responsibility for compliance to Design Control Requirements

In-depth knowledge of Medical Device Risk Management practices according to ISO 14971 including application of Risk Management to all the stages of software development including dFMEA/sFMEA.

A lengthy track record in effective application of Design Control best practices to medical device software development teams

Knowledgeable of AAMI Technical Information Reports including: TIR80002-1 – Guidance on the application of ISO14971 to Medical Device Software, TIR45 - Using Agile in Medical Device Software Development and TIR36 - Validation Of Software For Regulated Processes

In-dept experience in all general FDA and ISO 13485 Quality System processes including: Management Review, Document Control, Training, CAPA, Audits, Complaints, Supplier Management, SOPs, etc.

Ability to lead and manage various Regulatory activities and meetings including CAPA, risk analysis, documentation and audit meetings

Detail oriented and well organized with excellent skills in written and verbal communications and analytical and strategic thinking

Ability to work independently and to collaborate effectively on teams

Experience working on diabetes-related product desired

The Company:

Each year, diabetes, obesity, and other cardiometabolic diseases cause the highest incidence of death, disability, and healthcare system costs. At Glooko, we make it simpler for people with these illnesses to connect with their physicians and care teams. Glooko is the universal platform for providing an FDA-cleared, HIPAA-compliant, EU MDR-certified Web and Mobile (iOS and Android) application for people with clinicians who treat them.

Glooko accelerates research and improves care by making it simpler for people to collect and share their health data with physicians and researchers. The platform seamlessly unifies and visualizes data from over 210 devices, including blood glucose meters, insulin pumps, continuous glucose monitors, activity trackers, and biometric devices. Connecting to these devices allows Glooko to deliver insights that improve personal and clinical decision support. Patients and providers have one place to view their health management information, including medications, food intake, exercise, and biometrics. The platform makes it easier for physicians to monitor and deliver more personalized care remotely.

Glooko’s mobile app and web dashboard enable patients to track and proactively manage their diabetes care easily. Glooko’s Population Tracker and APIs offer diabetes-centric analytics and insightful reports that enable clinicians to identify at-risk patients. Clinicians can send pattern-triggered notifications to patients, health systems, and payers.

Our proprietary platforms enable clinical trial conduct and acceleration by leveraging advanced patient selection and site identification tools as well as remote device and e-PRO data collection capabilities. This platform's capabilities support the rapid development and iteration of digital companion and therapeutic applications.

Launched in 2010, Glooko is funded and managed by visionary technologists and leaders in healthcare.

#J-18808-Ljbffr

  • Senior Brand Designer

    3 weeks ago

    Palo Alto, United States Assured Full time

    Job DescriptionJob DescriptionAssured is on a mission to modernize insurance. Claims processing (i.e. should we pay this claim?), while often overlooked, is the foundation of the entire industry. It’s currently highly manual, involving phone calls, faxes, and gut instinct—costing tens of billions of dollars a year. We can do better.At Assured, we provide...

  • Senior Brand Designer

    2 weeks ago

    Palo Alto, United States Assured Full time

    Job DescriptionJob DescriptionAssured is on a mission to modernize insurance. Claims processing (i.e. should we pay this claim?), while often overlooked, is the foundation of the entire industry. It’s currently highly manual, involving phone calls, faxes, and gut instinct—costing tens of billions of dollars a year. We can do better.At Assured, we provide...

  • Senior Brand Designer

    1 week ago

    Palo Alto, United States Assured Full time

    Job DescriptionJob DescriptionAssured is on a mission to modernize insurance. Claims processing (i.e. should we pay this claim?), while often overlooked, is the foundation of the entire industry. It’s currently highly manual, involving phone calls, faxes, and gut instinct—costing tens of billions of dollars a year. We can do better.At Assured, we provide...

  • Senior Brand Designer

    4 weeks ago

    Palo Alto, United States Assured Full time

    Job DescriptionJob DescriptionAssured is on a mission to modernize insurance. Claims processing (i.e. should we pay this claim?), while often overlooked, is the foundation of the entire industry. It’s currently highly manual, involving phone calls, faxes, and gut instinct—costing tens of billions of dollars a year. We can do better.At Assured, we provide...

  • Senior Brand Designer

    3 weeks ago

    Palo Alto, United States Assured Full time

    Job DescriptionJob DescriptionAssured is on a mission to modernize insurance. Claims processing (i.e. should we pay this claim?), while often overlooked, is the foundation of the entire industry. It’s currently highly manual, involving phone calls, faxes, and gut instinct—costing tens of billions of dollars a year. We can do better.At Assured, we provide...

  • Senior Server Engineer

    2 weeks ago

    Palo Alto, United States Cognoa Full time

    **Senior Server Engineer** * Palo Alto, CA - Remote OK * Full-Time * Technology * Senior Server Engineer **Senior Server Engineer** (full-stack rails) to join our server team who has in-depth experience building high quality, interactive products using proven web technologies such as **Ruby**, **Rails**, and **Javascript**. Our engineering team writes...

  • Senior Physical Design Engineer, Autopilot AI

    2 months ago

    Palo Alto, United States CareerBuilder Full time

    **Senior Physical Design Engineer, Autopilot AI (Dojo)** ????Engineering & Information Technology????Palo Alto, California?? ID98124????Full-time Responsibilities * The candidate will be responsible for leading and driving large designblocks from early design stage to tape out. * Work responsibilities include synthesizing extremely high speed designs,...

  • Senior Mechanical Reliability Engineer

    4 weeks ago

    Palo Alto, United States Audubon Companies Full time

    External Description Senior Mechanical Reliability Engineer Direct Hire Laplace, LA Immediate Need PTO, Benefits, and 401k Long term position This position is not open to international candidates, and does not offer relocation or per diem Audubon is currently seeking a Senior Mechanical Reliability Engineer to be part of a project team working onsite at a...

  • Senior Hardware Design Engineer

    2 weeks ago

    Palo Alto, United States PSI Quantum Full time

    PsiQuantum is on a mission to build the world's first fault tolerant quantum computer capable of tackling today's most intractable computational challenges to deliver transformative results. We know that means it will need roughly 1 million qubits and will be building scale in size. Quantum computing is expected to deliver breakthroughs for today's still...

  • Senior Design Verification Engineer

    3 weeks ago

    Palo Alto, United States SambaNova Systems Full time

    The third era of AI has arrived, powered by Generative AI. Generative AI is achieving step-function increases in scale, versatility, and accuracy compared to legacy AI technologies, presenting an opportunity for organizations to fundamentally transform their business and operations. SambaNova Suite is enabling organizations and enterprises to achieve the...

  • Senior Design Verification Engineer

    1 week ago

    Palo Alto, United States SambaNova Systems Full time

    The third era of AI has arrived, powered by Generative AI. Generative AI is achieving step-function increases in scale, versatility, and accuracy compared to legacy AI technologies, presenting an opportunity for organizations to fundamentally transform their business and operations. SambaNova Suite is enabling organizations and enterprises to achieve the...

  • Senior Software Development Engineer, Search Quality

    3 weeks ago

    Palo Alto, California, United States Amazon Full time

    This is a unique opportunity to build technology and science that millions of people will use every day. Are you excited about working on large scale Natural Language Processing (NLP), Machine Learning (ML), and Deep Learning (DL)?We are embarking on a multi-year journey to improve the shopping experience for customers globally. Amazon Search team creates...

  • Senior Software Development Engineer, Search Quality

    1 week ago

    Palo Alto, California, United States Amazon Full time

    This is a unique opportunity to build technology and science that millions of people will use every day. Are you excited about working on large scale Natural Language Processing (NLP), Machine Learning (ML), and Deep Learning (DL)?We are embarking on a multi-year journey to improve the shopping experience for customers globally. Amazon Search team creates...

  • Quality Engineer

    3 weeks ago

    Palo Alto, California, United States Magna International Inc. Full time

    Job Number: 62865 Group: Magna Mechatronics, Mirrors & Lighting Division: Magna Mirrors Lowell Job Type: Permanent/Regular Location: ALTO Work Style: On-Site About usWe see a future where everyone can live and move without limitations. That's why we are developing technologies, systems and concepts that make vehicles safer and cleaner, while serving our...

  • Quality Engineer

    1 week ago

    Palo Alto, California, United States Magna International Inc. Full time

    Job Number: 62865 Group: Magna Mechatronics, Mirrors & Lighting Division: Magna Mirrors Lowell Job Type: Permanent/Regular Location: ALTO Work Style: On-Site About usWe see a future where everyone can live and move without limitations. That's why we are developing technologies, systems and concepts that make vehicles safer and cleaner, while serving our...

  • Senior Design Verification Engineer

    3 weeks ago

    Palo Alto, United States SambaNova Systems Full time

    The third era of AI has arrived, powered by Generative AI. Generative AI is achieving step-function increases in scale, versatility, and accuracy compared to legacy AI technologies, presenting an opportunity for organizations to fundamentally transform their business and operations. SambaNova Suite™ is enabling organizations and enterprises to achieve the...

  • Solidworks Senior Mechanical Design Engineer

    2 weeks ago

    Palo Alto, CA, United States Storm4 Full time

    Senior Mechanical Engineer I am working with a super exciting, leading modular on-site Hydrogen company in Palo Alto, CA who are looking for a Senior Mechanical Engineer to join their team! Create detailed designs, and build mechanical prototypes. Ability to utilize and arrange optimal hardware components including sensors, pipes, and valves. Complete...

  • Quality Assurance Lead

    2 weeks ago

    Palo Alto, CA, United States Pull Full time

    Pull Systems helps electric vehicle (EV) manufacturers, suppliers and operators manage their fleets with increasing levels of automation. Our software platform is underpinned by a library of machine learning models that predict battery behavior using a world class database of 3 years of operating history from nearly 100k vehicles. With Pull Systems, our...

  • Senior Manager, Motor Design

    3 weeks ago

    Palo Alto, California, United States Ford Motor Company Full time

    At Ford Motor Company, we believe freedom of movement drives human progress. We also believe in providing you with the freedom to define and realize your dreams With our incredible plans for the future of mobility, we have a wide variety of opportunities for you to accelerate your career potential as you help us define tomorrow's transportation.Ford Model E...

  • Senior Manager, Motor Design

    1 week ago

    Palo Alto, California, United States Ford Motor Company Full time

    At Ford Motor Company, we believe freedom of movement drives human progress. We also believe in providing you with the freedom to define and realize your dreams With our incredible plans for the future of mobility, we have a wide variety of opportunities for you to accelerate your career potential as you help us define tomorrow's transportation.Ford Model E...