ShanX Medtech BV (SXM, NL) is a dynamic young company dedicated to revolutionizing healthcare through innovative diagnostic tools. Our journey began with a deeply personal experience—the founder's mother's near-fatal struggle with a poorly treated bacterial infection. This ignited our mission to transform infection management, propelling us to develop pioneering solutions that prevent unnecessary suffering.
At SXM, impact is paramount. We're proud to introduce KAIROS IVD, our groundbreaking rapid antibiotic susceptibility testing device, poised to redefine how bacterial infections are treated. Our goal is clear: to equip healthcare professionals with the means to make informed treatment decisions swiftly and accurately. Through our innovative solutions, we're combating antibiotic resistance, enhancing patient outcomes, and saving lives.
As a Project Leader you will play a critical role in driving the successful execution of KAIROS to completion, and you’ll be responsible for ensuring that projects are well planned, aligned and coordinated, delivered on time, within budget, and in accordance with quality and regulatory requirements.
This is a part-time contract for 16 hours per week, extending over three years, with the possibility of extension and potential for an increased work week.
Your responsibilities include but are not limited to:
Project Planning: Collaborating with stakeholders to develop comprehensive project plans, timelines, and budgets to ensure alignment with company goals and objectives.
Team Management: Leading and motivating cross-functional project teams, including scientists, engineers, regulatory specialists, and quality assurance personnel and external subcontractors. Assigning tasks, setting priorities, and fostering a collaborative and productive work environment.
Resource Allocation: Identifying resource requirements, including personnel, equipment, and budgetary needs, and allocating resources effectively to meet project milestones and deadlines.
Risk Management: Identifying potential project risks and issues that may impact project timelines or outcomes and developing strategies to mitigate risks and ensure project success.
Communication: Serving as the primary point of contact for project stakeholders, providing regular updates on project progress, milestones, and issues. Facilitating effective communication and collaboration among team members and stakeholders.
Quality Assurance: Ensuring that all project activities comply with regulatory requirements, quality standards, and company policies. Implementing quality assurance processes and procedures to maintain the highest standards of product quality and safety.
Problem-Solving: Addressing challenges and obstacles that arise during the course of the project and implementing creative solutions to overcome them. Proactively identifying opportunities for process improvement and optimization.
Documentation: Maintaining accurate and comprehensive project documentation, including project plans, meeting minutes, progress reports, and regulatory submissions. Ensuring that all project documentation is up-to-date and accessible to stakeholders as needed. Prepare milestone reviews.
Project Closure: Facilitating project closure activities, including finalizing deliverables, conducting post-project reviews, and documenting lessons learned. Ensuring smooth transition of project outcomes to relevant stakeholders, such as manufacturing, marketing, and sales teams.
• Master’s degree in biology, Biomedical Engineering, Chemistry, or a related field.
• Minimally 2 years’ experience in project management, with a preference in in-vitro diagnostics development.
• Basic understanding of in vitro diagnostics principles and technologies is beneficial. Familiarity with regulatory requirements such as FDA regulations and ISO standards, notably ISO13485.
• Problem solving skills and ability to adapt quickly to changes.
• Competitive compensation and benefits package
• Access to professional development opportunities for career growth and advancement, including training resources.
• Flexible schedule and work arrangements
• Dynamic and collaborative work environment
Join us in shaping the future of healthcare, where every moment is vital in the fight against bacterial infections. We're seeking a motivated Project Leader to join our team and contribute to the timely development of this crucial diagnostic device. This is an exceptional opportunity to join us in our early stages and play a pivotal role in our future success.