Quality Engineer IV - Software V&V - Remote

Danaher Chaska , MN 55318

Posted 2 months ago

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. You'll find the Danaher Business System, which makes everything possible.

At Beckman Coulter, at the heart of what we do, witness our shared purpose-helping realize life's potential-in action.

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 V&V for Beckman Coulter Diagnostics is responsible for overseeing software validation and verification activities which includes understanding emerging technologies such as 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 software regulatory requirements at the intersection of the medical device industry, the software industry and data science.

You will report to the Global Process Owner responsible for emerging technologies Global Quality efforts, implementing and sustaining compliance to industry regulations regarding CDS, AI-ML, and SaMD, and drive process improvement.

In this role, you will have the opportunity to:

  • Influence global 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, 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.

  • Demonstrate real-world experience to lead the company through global regulatory pathways for:

  • Risk Management, Human Factors, and V&V for SaMD, CDS, and AI-ML models

  • Product software patching; both security and updates/upgrades, including AI-ML iterations

  • Partnership with data source companies, such as: IBM, Epic, and other EMR data sources

  • Company instrument data management for use in development of Intellectual Property

  • Function as global representative during internal as well as Agency /3rd Party Audits and assist in the preparation and submission of audit responses and requests for information to Notified Bodies.

  • Consult on QA support to Beckman Coulter software product development projects in areas of Quality Systems (Design Controls) and validation related activities.

  • Drive continuous improvement of software development procedures, methods, tools, techniques, and training, etc. to support project efficiencies.

The essential requirements of the job include:

  • Bachelor's degree in related field with 9+ years' experience OR Master's degree in field with 7+ years' experience OR Doctoral degree in field with 4+ years' experience.

  • Demonstrated experience in product (SaMD and/or instrument software) software development processes, code and/or unit inspection, and maintenance oversight of post-market released software such as change management and defect management.

  • 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 and HIPAA requirements.

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

Accelerate your career while driving innovation that improves lives! Work hard and try new things, with guidance from committed leaders, powerful DBS tools, and the support of a global organization. With 67,000 associates across the globe, the 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. 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.

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