- Fulfill the Development QA / Design Assurance role on Software Product Development Core and/or Design Change Teams as the design progresses through the development lifecycle.
- Collaborate constructively with other functional group team members to define performance requirements, conduct risk analysis, and establish right-size verification test plans.
- Facilitate risk assessments for new designs and design changes at various project development phases. Ensure that risk management activities are performed in accordance with company procedure and ISO 14971
- Ensure compliance with applicable regulatory agency requirements, published standards, company policies/procedures, local procedures/work instructions, and project-specific plans.
- Assure the product Design History File (DHF) is auditable, traceable, concisely organized, complete, and supports regulatory product registration needs.
- Drive continuous improvement of new product development procedures, methods, tools, techniques, training, etc., to support project-specific efficiencies.
- BS in Software Engineering or related technical field with 9+ years of experience, a Master's degree in a field with 7+ years of relevant experience, or a Doctoral degree with 4+ years of experience
- 1-2 years of experience within product design and/or manufacturing environment supporting software/hardware development projects.
- Proven knowledge of design control processes, including design change, risk management, design requirements, design V&V, and design transfer
- Artificial Intelligence or Machine Learning
- Quality Assurance
- Agile Development
- Experience in a regulated industry, specifically knowledge of IVD and the Medical Device industry
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Staff Quality Assurance Engineer - West Sacramento, CA, United States - Beckman Coulter Diagnostics
Description
Wondering what's within Beckman Coulter Diagnostics? Take a closer look.
At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.
The Staff Quality Assurance role for Beckman Coulter Diagnostics supports cross-functional core team members in the software product design and development lifecycle of the Microbiology Business Unit in West Sacramento, California.
You will be part of the US Diagnostics Development Quality (Design Assurance) team and report to the Manager of Quality Assurance responsible for Diagnostic Software Development Quality. Our goal is to provide high-quality, reliable, and regulatory-compliant products to support worldwide market release in meeting the needs of our clinical customers, our patients, and Beckman's business growth objectives. If you thrive in a fast-paced and diverse role and want to work to build a world-class Quality organization—read on
In this role, you will have the opportunity to:
The essential requirements of the job include:
It would be a plus if you also possess previous experience in:
At Beckman Coulter Diagnostics, we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for an on-site work arrangement which is defined as being on-site a minimum of 3 days each week. The other 2 days can be on-site or remotely from your home. Additional information about this work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.
The salary range OR the hourly range for this role is $110k-$125. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here .
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.
