Digital Diagnostics Quality Engineer - Remote Considered

Company: Danaher
Location: Greensboro
Posted on: June 12, 2021

Job Description:

Wondering what's within Beckman Coulter?

Take a closer look.

Join a team where you can be heard, be supported, and always be yourself. At Beckman Coulter, a Danaher company, we're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. We are dedicated to advancing and optimizing the laboratory to move science and health care forward for more than 80 years. Find the opportunity to build relevant career, be creative, and try new things with the support needed to be successful. Find the Danaher Business System, which makes everything possible.

And no matter where you look at Beckman Coulter, at the heart of what we do, you'll witness our shared purpose-helping realize life's potential-in action. Our work helps improve millions of lives.

We hope you'll see yourself here, too.

What you find at Beckman Coulter -and within yourself - might just change the world!

The Staff Quality Engineer, Software, Digital Health V&V for Beckman Coulter Diagnostics is responsible for overseeing software validation and verification activities which includes understanding emerging technologies such as Digital Health, artificial intelligence, machine learning, Software as a Medical Device (SaMD), and Clinical Decision Support (CDS).

This position is part of the global Quality Assurance organization and can be located remotely in the USA. This role will implement and manage quality management systems to meet modern Digital Health regulatory requirements at the intersection of the medical device industry, the software industry, and data science.

You will report to the Senior Director, Quality Systems & Clinical Decision Support Solutions for emerging technologies Global Quality efforts, implementing and sustaining compliance to industry regulations regarding CDS, AI-ML, and SaMD, and drive process improvement. This position can be located in Brea, CA or Miami, FL or Remote will be considered.

In this role, you will have the opportunity to:

• Influence global strategies and decisions as a Subject Matter Expert for policies, procedures, and work instructions to ensure compliance with international regulations and standards. This includes compliance with Food & Drug Administration (FDA), Medical Device Single Audit Program (MDSAP), HIPAA, GDPR, HL7, FHIR, FDA QSR, 21st Century Cures Act, IEC 62304:2016, ISO 13485, ISO 14971, and European Union Medical Device Directives (MDD); as well as other applicable global regulatory requirements and standards.
• Drive the adoption of a new quality management system and continuous improvement for Digital Health.
• Provide strategic direction for CDS, SaMD, AI/ML AI/ML new product development and design change teams in terms of different quality functions
• Keep the management up to date on the Digital Health developments, the regulatory needs and help train the organization on the quality requirements.
• Demonstrate real-world experience to lead the company and projects through:
• Software product development, design controls, verification & validation, risk management, qualifications, and human factors for SaMD, CDS, and AI-ML models
• Understanding of various EHR (Electronic Health Records) and EMR (Electronic Medical Records).
• Function as a global representative in the internal as well as Agency /3rd Party Audits.

The essential requirements of the job include:

• Bachelor's degree in related field with 5+ years' experience OR Master's degree in an area with 3+ years' experience OR Doctoral degree in a field with 0-2 years' experience.
• Experience in the application of design controls in accordance with 21 CFR Part 820, ISO 13485, and ISO 9001 for the development of SaMD/CDS products and design changes
• Experience in producing detailed and comprehensive quality system documentation and reports.
• Demonstrated experience in product (SaMD, CDS) software development processes and maintenance oversight of post-market released software such as change management.
• Ensure compliant and complete product documentation, inclusive of DHFs, with a particular focus on design controls, risk management, and document controls.

It would be a plus if you also possess previous experience in:

• Demonstrated experience in the implementation of cybersecurity and data privacy industry practices for SaMD, CDS, AI-ML, and related infrastructure data storage, with a working knowledge of industry standards and regulations for GDPR HIPAA requirements.
• Experience engaging with FDA's Digital Health Program a plus.
• Knowledge on 510(k) submission process.
• Understand the industry trends and regulatory challenges with the digital health space. Partnerships and participation in advocacy groups and an understanding of market trends and competitive activities.

Beckman Coulter, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

We believe you'll like what you see.

At Beckman Coulter, we're driven by a sense of wonder for what we can create-and what we can become. Here, you'll accelerate your career while driving innovation that improves lives. You'll work hard and try new things, with guidance from committed leaders, powerful DBS tools, and the support of a global organization. As part of the Danaher family of 67,000 associates across the globe, your possibilities for growth and development are unparalleled.

We believe that creativity and innovation thrive when the most diverse set of voices are heard, and that's why we're taking concrete steps to ensure that we're fostering an inclusive and engaging workplace for our team. If you'd like to learn more, read stories from our associates on our Careers Blog or contact one of our recruiters.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here.

Keywords: Danaher, Greensboro , Digital Diagnostics Quality Engineer - Remote Considered, Other , Greensboro, North Carolina