Sysmex Astrego - Together for a better healthcare journey

At Sysmex Astrego, we are working towards something bigger than ourselves — improving the diagnosis and treatment of bacterial infections and contributing to the fight against antibiotic resistance. We are a medical technology company based in Uppsala, Sweden, and part of the global Sysmex Group. Here, scientific excellence, cutting-edge technology, and a genuine desire to make a difference come together.

Our product, the PA-100 AST System, which was awarded the prestigious Longitude Prize 2024, enables rapid identification of both the bacteria causing the infection and its antibiotic resistance, in less than an hour. This allows patients to receive the right treatment much faster, which is crucial both for individual health and for global public health.

To strengthen our team, we are now looking for an experienced and driven Senior Project Manager with a proven track record in IVD product development.

The Role

As Project Manager at Sysmex Astrego, you will play a key role in driving our product development projects from early feasibility to global launch. You will lead cross-functional project teams covering R&D, QA/RA and Operations, ensuring delivery on time, within budget and at the right quality.

You will closely collaborate with both internal stakeholders and external partners worldwide, ensuring project execution according to goals and compliance with regulatory requirements in EU, US, and Japan.

Responsibilities

• Lead and manage IVD development projects (systems and assays) from concept to global commercialization, building on the prize winning PA-100 AST System.
• Establish project plans, budgets, timelines and deliverables in line with Stage-Gate methodology.
• Lead, Coordinate and facilitate cross-functional project teams.
• Ensure compliance with regulatory requirements (IVDR, FDA, PMDA, etc.).
• Oversee quality and documentation processes according to ISO 13485 and ISO14971.
• Report project status, risks, deviations and decisions to management and steering committees.
• Contribute to continuous improvement of project models, processes, and tools for project management.

Requirements

• Master’s degree in Engineering, Life Sciences or equivalent.
• 10+ years of experience in IVD/Medical device product development.
• Proven track record of leading global product launches of diagnostic systems (hardware, software and assays).
• Deep understanding of regulatory requirements in EU (IVDR), and US (FDA 510k/de novo/PMA).
• Hands-on experience working under ISO 13485 (quality management systems).
• Good working knowledge of ISO 14971 (risk management for medical devices).
• Solid experience in cross-functional project leadership in an international setting.
• Strong knowledge of project management methodologies (e.g., Stage-Gate, PMP, Prince2).
• Fluent in English, both written and spoken.

Preferred qualifications

• Experience in both system and assay development.
• Knowledge of microbiology and/or diagnostic point of care devices.
• Prior experience in a global corporate or matrix organization.
• Ability to balance strategic perspective with hands-on execution.
• Swedish language skills are an advantage.

Why Sysmex Astrego?
Sysmex Astrego is committed to creating an inclusive workplace that values diversity.
We are an equal opportunity employer and ensure that every employee has the opportunity to contribute with their expertise and unique perspectives to the team.

We offer you:

• A central role in a rapidly growing company shaping the future of diagnostics.
• Opportunity to influence the full product lifecycle – from idea to clinical reality.
• An international network within the Sysmex Group.
• A strong sense of community in a multicultural workplace with staff activities, team-building events and shared breakfasts at the office
• A competitive benefits package including wellness allowance, dedicated wellness hour, free parking and the option to lease a benefit bicycle

We will be conducting interviews on an ongoing basis, so please apply as soon as possible, no later than 30th of september.

Please note that we do not wish to be contacted by external recruitment agencies or staffing companies. Thank you!