Software Design Quality Assurance Staff Engineer

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Job Description

Join our Life Sciences Solutions team and collaborate with leading organizations, laboratories, and healthcare companies to drive scientific breakthroughs! We offer a wide range of products, services, and digital solutions supporting genetic testing, genomic analysis, proteomics, cell biology, precision medicine, and drug discovery. Our cutting-edge technologies are also used in human identification, forensics, and novel treatments like CAR-T cell therapy. With deep scientific and technical expertise, our dedicated colleagues help customers across diagnostics, healthcare, academia, government, pharmaceuticals, and biotechnology tackle global challenges and enhance human health. Be a part of our dynamic team and help shape the future of science and medicine!

You'll join the rest of our Thermo Fisher Scientific team in Singapore, our strategic hub for Asia-Pacific! You'll be amazed by our state-of-the-art facilities including our sterile drug manufacturing facility, Customer Experience Center, and Bioprocess Design Center. We specialize in instrument and assay development for life science, pharmaceutical, and clinical diagnostic markets, leveraging expertise in computer-aided design, precision engineering, additive manufacturing, and cloud engineering! This is your chance to drive innovation at the center of Asia's most exciting scientific ecosystem!

DESCRIPTION:

When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Job Description and Key Responsibilities
As part of our team at Thermo Fisher Scientific, you'll do important work in helping to build software systems and products that help governments, hospitals, and laboratories around the world identify infectious and inherited diseases. Your work will have real-world impact and you'll have incredible opportunity to achieve your career goals.

Working in the Life Sciences Solutions Group (LSG), you will support Design Quality and compliance for software product development across all aspects of the SDLC. Your knowledge of design compliance and regulatory guidance – ISO 13485, IEC 62304, 21 CFR 820, ISO 14971, and global cybersecurity standards – will propel our collective success in delivering IVD medical device and RUO software and instrument systems in a complex and evolving regulatory environment. Your experience with QMS and software product development will help to enable the success of software engineering, systems, and product teams across the globe.

We will ensure that software team members are trained in design-compliant company procedures and will work to advance software engineering procedures and associated training modules. Our guidance and expertise will help LSG establish a world class, IVD-oriented culture around Design Quality for Software as a Medical Device.

Project Leadership
• Serve as Software Design Quality lead on multiple programs with significant business and regulatory impact.
• Contribute your Design Quality expertise to next generation NPI software and instrument systems.
• Coach, lead, and enable software teams to deliver products efficiently and in compliance with FDA and EU regulatory standards.

Process Improvement
• Lead continuous process improvement initiatives for software product development in areas such as cybersecurity, AI adoption, risk management, pre- and post-market support, and change control.

• Contribute to an evolving training curriculum to enable and promote cultural adoption of design compliant SDLC activities.
• Study evolving global standards and perform gap assessments to incorporate process improvement opportunities.

Project Execution
• Provide guidance throughout SDLC activities to enable design compliance with internal procedures and regulatory/international standards.
• Collaborate with project leaders across disciplines to ensure effective DHF management for complex regulated product development.
• Facilitate SDLC process activities and provide consultation for complaint handling, change management, and CAPA process activities.
• Lead risk management and software hazard analysis activities at the project/program level.
• Serve as Software Design Quality SME in regulatory compliance audits and inspections.

REQUIREMENTS:

Minimum Qualifications
• BS in computer science, engineering, biology, or similar technical subject area.
• Direct experience in software product development activities from product concept to launch.
• 5-10 years of experience in FDA/EU regulated environments (ISO 13485).

• Understanding of design control activities for planning, design, development, verification, and validation of Software as a Medical Device (IEC 62304).
• Working knowledge of ISO 14971 and 21 CFR Part 11.

• Project planning and advanced computer skills a plus.

Professional Characteristics:
• Ability to organize and manage your time and activities across multiple, concurrent projects.
• Work attitude that exhibits drive, creativity, collaboration, decision making, and ambition.
• Ability to build and maintain relationships with project team members from all subject areas, including software engineering, regulatory, and program management.
• Highly functioning Design Quality SME in a dynamic, multi-disciplinary business and scientific environment.

Leadership Skills:
• Proven track record influencing others and leading significant change.
• Excellent interpersonal, verbal, and written communication skills in English.