Senior Project Manager IVD Product Development

Haeger & Carlsson is proud to partner with Sysmex Astrego, an innovative and rapidly growing in vitro diagnostics company, in the recruitment of their next Senior Project Manager – IVD Product Development. You will join a collaborative, fast‑moving, and innovation‑driven culture where scientific rigor meets entrepreneurial energy. This is a high‑impact role for a hands‑on project leader who wants to drive innovative diagnostic solutions from early concept to global launch.

To succeed, you bring solid experience in IVD or medical device development and are confident navigating complex, cross‑functional, and international environments. You balance strategic thinking with practical execution and excel where innovation meets regulatory rigor. Working closely with R&D, QA/RA, and Operations, you create structure, maintain clarity, and proactively resolve challenges to ensure both technical and commercial success.

As Senior Project Manager – IVD Product Development, you will own system and assay development projects — ensuring progress, regulatory compliance, and successful market readiness. You will lead the process from feasibility and design through verification and validation. In close collaboration with Sysmex's global organization, you will prepare the product for international commercialization, delivering on time, on budget, and in compliance with EU, US, and Japanese regulations.

You will report to the Head of PMO and be based in Uppsala, where on‑site collaboration is key to effective project execution and team alignment.

Sysmex Astrego AB was founded as Astrego Diagnostics AB in 2017, based on 10 years of basic research at Uppsala University, with the vision of developing diagnostic products to support the global fight against antibiotic resistance. In 2022, the company was acquired by Sysmex Corporation to bring its products to the global market.

Sysmex Corporation is a global diagnostics company headquartered in Kobe, Japan, with more than 9,200 employees. Sysmex has delivered high‑quality healthcare products for over 50 years, focusing on medical analytical devices and IT solutions for the laboratory sector worldwide — particularly in hematology, coagulation, and urinalysis.

Key Responsibilities

o Lead IVD development projects (systems and assays) from concept to global launch, including next‑generation work on the PA‑100 AST System.

o Build and maintain project plans, budgets, timelines, and deliverables using Stage‑Gate methodology.

o Drive and coordinate cross‑functional teams across R&D, QA/RA, and Operations to ensure strong execution.

o Ensure compliance with IVDR, FDA (510k/de novo/PMA), PMDA, and other applicable regulatory requirements.

o Oversee documentation, quality processes, and risk management in line with ISO 13485 and ISO 14971.

o Identify and mitigate project risks; report progress, issues, and key decisions to management and steering committees.

o Contribute to continuous improvement of project methods, governance, and project‑management tools.

o Manage both new product development and lifecycle updates to maintain competitiveness, compliance, and scalability.

Qualifications

o Master's degree in Engineering, Life Sciences, Biotechnology or similar.

o Extensive experience in IVD or medical device product development.

o Proven track record of leading global launches of diagnostic systems (hardware, software, assays).

o Strong knowledge of IVDR and FDA pathways (510k, de novo, PMA).

o Hands‑on experience with ISO 13485 and solid understanding of QMS requirements.

o Working knowledge of ISO 14971 and risk‑management practices.

o Extensive experience leading cross‑functional teams in international settings.

o Strong command of project‑management frameworks such as Stage‑Gate, PMP, or Prince2.

o Excellent English communication skills, spoken and written.

Preferred qualifications

o Experience in both system and assay development.

o Knowledge of microbiology and/or point‑of‑care diagnostics.

o Experience in global corporate or matrix organizations.

o Ability to combine strategic leadership with hands‑on involvement.

o Swedish language skills are an advantage.

Questions are answered by:

Anna Emterling, Sr Recruitment Manager