As a global leader in mass spectrometry, SCIEX delivers solutions for precision detection and quantification of molecules to help protect and advance the wellness and safety of all. Because of our 50 years of groundbreaking innovation, our customers can quickly respond to environmental hazards, better understand biomarkers relevant to disease, improve patient care in the clinic, bring relevant drugs to market faster, and keep food healthier and safer. At SCIEX, you’ll find a rewarding role that amplifies your impact on the world and helps you realize life’s potential.
SCIEX is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
The Principal Design Quality Engineer will drive outstanding product quality, safety, design and reliability through the R&D/Software Development and Quality teams and into the product. This meaningful technical position within the quality team will have direct influence on software and system product quality for R&D/production builds and release to market.
While the focus of this role is intended to be Software products, support of Hardware (Electromechanical) products as well as complex systems comprising of Software and Hardware systems may also be required.
Actively participate in and/or facilitate the development, review and approval of requirements and deliverables required to support product software development (planning, requirements, architecture, verification/validation etc.)
Ensure SW FMEA are conducted to help drive good designs at early development stages. Participate in FMEA activities and provide mentorship as needed.
Conduct evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation against SCIEX processes and work instructions.
Review software systems design, change specifications, and plans against contractual and/or process requirements.
Assess both the safety risk and security risk for the OTS/SOUP used in the product software. Conduct OTS/SOUP analysis and generate Basic Documentation and/or Special Documentation per FDA mentorship.
Compile the List of SOUP for third party libraries embedded in the medical device software products.
Provide leadership regarding non-product software validation activities, demonstrate strong working knowledge of 21 CFR Part 820.70
Interact and form constructive working relationships with all levels of leadership within Quality, Marketing, R&D, Systems Engineering and Operations.
Advise Design Quality Engineers to act as trusted advisors and as project core team members communicate and pull in other Quality groups proactively as needed
Proactively advance issues and risks appropriately through appropriate channels to Management.
Be able to recognize opportunities for enhancements and continuous improvement of existing processes.
Education and/or Work Experience Requirements:
B.S. or higher preferred in Computer Science, Software Engineering or relevant engineering subject areas, or equal years of work experience, with 5+ years in a software quality, systems engineering or test engineering.
Strong working knowledge of IEC 62304, IEC 62366, 21 CFR Part 820.70
Experience as an internal auditor combined with validated understanding of ISO 13485 and ISO 9001 is preferred
Knowledge of developing and testing medical devices incorporating software
Working knowledge in one of the following software languages: C#, C, C++
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful tools and the stability of a tested organization.
Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.
If you’ve ever wondered what’s within you, there’s no better time to find out.
Ability to author technical reports, business correspondence and standard operating procedures.
Ability to apply knowledge and work with development and supply vendors to ensure compliance to SCIEX requirements.
Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.