Senior Systems Engineer

Work Schedule

Environmental Conditions

Job Description

In this role you will be part of Thermo Fisher Scientifics ImmunoDiagnostics Division (IDD) which develops manufactures and markets diagnostic tests for allergy asthma and autoimmune diseases.

With approximately 1900 employees worldwide IDD is the global leader in in vitro allergy diagnostics and a leading provider of autoimmune diagnostics in Europe. Our Uppsala site home to more than 750 employees serves as the divisions global headquarters and includes both research and development and manufacturing operations.

Your future challenge

We are looking for an experienced Senior Systems Engineer to join our Sustaining Engineering & Compliance team within the R&D instrument department.

In this role you will play a key part in ensuring the long-term performance compliance and continuous improvement of our diagnostic products. As a technical leader you will drive Quality Management System (QMS) development support product lifecycle activities and collaborate with cross-functional teams to ensure our products continue to meet customer business and regulatory requirements.

What you will do

As a Senior Systems Engineer you will:

• Lead the development implementation and continuous improvement of Quality Management System (QMS) processes to ensure compliance with applicable regulatory requirements.
• Maintain and improve technical documentation in accordance with the quality system.
• Provide training and system support to colleagues on quality processes and tools.
• Lead and contribute to sustaining engineering and product development activities.
• Drive process improvement initiatives to enhance product quality efficiency and compliance.
• Lead design reviews and provide technical guidance throughout development and sustaining projects.
• Collaborate closely with Engineering Assay Development Quality Regulatory Affairs Manufacturing and other cross-functional teams to deliver effective technical solutions.

Who are you

You are an experienced systems engineer with a passion for quality technical leadership and continuous improvement. You enjoy working collaboratively across functions and are motivated by solving complex engineering challenges while ensuring regulatory compliance.

We believe you have:

• A Bachelors degree in Engineering Life Sciences or a related technical field.
• At least five years of experience in sustaining engineering product maintenance quality oversight or a similar role within the medical device diagnostics or another regulated industry.
• Strong knowledge of quality management systems and regulatory requirements for medical devices or scientific instruments.
• Experience leading technical initiatives and collaborating with multidisciplinary teams.
• Experience with Design Controls product lifecycle management and sustaining engineering.
• A structured approach with strong analytical and problem-solving skills.
• Experience mentoring colleagues and providing technical leadership.
• Excellent communication and stakeholder management skills.
• Fluent written and spoken English.

The following are considered an advantage:

• An advanced degree in Engineering Life Sciences or a related technical field.
• Experience working within FDA ISO 13485 or other regulated environments.
• Swedish language skills.

Why join Thermo Fisher Scientific

At Thermo Fisher Scientific your work contributes to improving patient care and advancing scientific discovery around the world. As part of our global organization youll collaborate with talented colleagues lead meaningful technical initiatives and help ensure the continued success of products that make a real difference for healthcare professionals and patients worldwide.

Our Mission is to enable our customers to make the world healthier cleaner and saferand our people are at the heart of making that possible.

Ready for your next challenge

We look forward to receiving your application.

Apply today!

Applications will be reviewed after the summer holiday period in August. The position will be filled as soon as a suitable candidate has been identified so we encourage you to submit your application as early as possible.