Sr Staff Engineer, Systems Design
Work Schedule
Standard Office Hours (40/wk)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life — enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while advancing science through research, development, and delivery of innovative technologies.
The job
We are seeking a highly skilled and experienced Sr Staff Systems Engineer to join our Instrument R\&D organization in Uppsala, Sweden. In this role, you will lead systems engineering activities for advanced instrument platforms and drive new product development programs from concept through commercialization.
The successful candidate will bring strong expertise in systems engineering within regulated environments, with deep knowledge of requirements management, quality processes, and regulatory compliance. You will work cross\-functionally across engineering, quality, regulatory, manufacturing, and product management teams to deliver robust and compliant solutions.
Key Responsibilities
- Lead systems engineering activities across complex instrument development projects.
- Define, manage, and maintain system and subsystem requirements throughout the product lifecycle.
- Drive system architecture, integration, verification, and validation activities.
- Support new product development initiatives from feasibility through release.
- Ensure compliance with applicable regulatory standards and quality management system requirements.
- Lead risk management activities including hazard analysis and mitigation planning.
- Collaborate closely with multidisciplinary teams including software, hardware, mechanical, quality, regulatory, and operations.
- Facilitate technical reviews, design reviews, and engineering change processes.
- Provide technical leadership, mentoring, and guidance to engineering teams and stakeholders.
- Contribute to continuous improvement of systems engineering methodologies and development processes.
- Bachelor’s, Master’s, or PhD degree in Engineering or a related technical discipline.
- Significant experience in systems engineering and new product development.
- Strong expertise in:
+ Regulatory compliance
+ Quality systems
+ Product development lifecycle processes
- Experience working in regulated industries such as medical devices, diagnostics, analytical instruments, or life sciences.
- Strong understanding of verification, validation, and risk management processes.
- Excellent communication and stakeholder management skills.
- Demonstrated ability to lead technically complex cross\-functional projects.
- Knowledge of standards and regulations such as ISO 13485, IEC 62304, ISO 14971, FDA design controls, or equivalent.
- Experience with analytical or laboratory instrumentation development.
- A meaningful role supporting development of technologies that advance science and healthcare.
- Collaborative international working environment.
- Opportunities for professional development and career growth.
- Competitive compensation and benefits package.
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