Vacant job

Miris AB, a global leader in human milk analysis technology, is seeking an experienced Project Manager to join our team in Uppsala, Sweden. We are passionate about making a difference in neonatal care and are looking for someone equally committed to delivering exceptional products to support new and existing customers worldwide.

About the Role

In this multifaceted role, you will be responsible for planning, coordination, and completion of projects and other R&D activities.

Your key duties and responsibilities will include:

• Perform detailed project plans that support given scope, timeframe, and budget.
• Define and update design input and design specifications to support market requirements and user needs.
• Procure and coordinate external consultants when needed.
• Perform risk analyses to minimize product and project risks.
• Ensure that design output is verified to meet design input requirements.
• Make sure to support the product registration process with relevant documentation.
• Monitor and track progress and report status, including any deviations to plan.
• Work and document according to company QMS and ensure compliance with ISO 13485 associated standards.
• Oversee post-market lifecycle management and act when needed.
• Participate in audits and inspections.

Who You Are

You are a structured and service-minded professional who thrives in a dynamic international work environment, always with the customer needs in mind. You have a great understanding of all technical disciplines included in general embedded products. You both enjoy leading people in large complex projects and yourself in smaller activities, from idea to completion. You are pragmatic and hands-on to make things happen. You have a strong driver to create value and deliver on time. You are a proactive problem solver who can balance multiple tasks while delivering high-quality results. You are an excellent leader as well as a team player and have no problem working on your own.

Qualifications

Must have:

• BSc or higher degree in Engineering Physics, Mechatronics, Biomedical Engineering, or similar.
• Minimum of 10 years experience in project management of embedded products within the medical industry.
• Very good understanding of mechanical, electrical, and software engineering, and work within cross-functional teams.
• Great communication skills in Swedish and English, both oral and written.
• Great skills in ISO 13485 and documentation according to associated standards.

Nice to have:

• Experience from development of IVD-instruments.
• Experience from hands-on systems engineering and test of embedded products.