Project Manager - Medical Devices

Onera Health

Eindhoven, Netherlands

Description

Onera is hiring a Project Manager to support R&D and to be a key contributor to the Onera digital health platform development. We offer a great opportunity for professional growth in an ambitious and fast-growing start-up. The key purpose of this position is to ensure that (medical device) projects are planned, executed, and completed in accordance with regulatory requirements and quality standards and within agreed timelines and budgets with stakeholders. 

Key Responsibilities

You will be part of a multidisciplinary, energetic, and internationally minded start-up team. You will have the different responsibilities listed below:

Project Planning and Initiation:
- Define project scope, objectives, and deliverables that support business goals in collaboration with senior management and stakeholders;
- Develop comprehensive project plans that include timelines, resources, budget, and risk management strategies;
- Ensure that project plans comply with our QMS and applicable regulatory standards.
Quality and Compliance:
- Ensure that all project deliverables meet quality standards and regulatory requirements;
- Work closely with the quality assurance team to integrate quality controls into the project workflow;
- Manage the Design History File (DHF) and ensure all design controls are implemented;
- Contributes in audits, ensuring availability of supporting evidence in timely manner.
Project Execution and Monitoring:
- Lead project teams to ensure timely and effective execution of project tasks;
- Monitor project progress against the plan, adjusting as needed to address deviations;
- Ensure all project activities and changes are documented, reviewed and approved in compliance with our QMS and maintain accurate project records;
- Manage changes to project scope, schedule, and costs using appropriate verification techniques.
Stakeholder Management, Communication and Reporting:
- Serve as the primary point of contact for project stakeholders, providing regular updates on project status, risks, and issues;
- Prepare and present project reports, including progress updates, risk assessments, and project outcomes to senior management and regulatory bodies;
- Monitor and manage project risks throughout the project lifecycle, implementing corrective actions as necessary.
Resource Management:
- Ensure product resource needs are met, including personnel, equipment, and materials;
- Coordinate with cross-functional teams, including R&D, quality assurance, regulatory affairs, production, and marketing;
- Coaching and advising project team members.

Requirements

Min. Bsc in technical field (Computer Science, Engineering, life sciences, business administration etc.);
A master’s degree in a relevant discipline, such as biomedical engineering, project management, or an MBA, can be advantageous.;
Experience with project management related to (medical) device product development (SW, HW, System);
Knowledge of project management methodologies and tools (PMP, Agile, Jira);
Understanding of ISO 13485 and knowledge of other relevant medical regulations (e.g., FDA, MDR, IVDR) , as well as IEC 62304 and IEC 60601 requirements, is a plus;
Proficiency in risk management principles and practices, esp. ISO14971;
Strong leadership skills with the ability to motivate and manage teams and excellent conflict resolution and negotiation skills;
Decision-making and problem-solving skills (analyze complex problems, identify root causes, implement effective solutions);
Excellent interpersonal and communication skills;
Strong focus on quality assurance and compliance;
Excellent organizational skills with the ability to manage multiple priorities and projects simultaneously. Strong attention to detail and ability to meet deadlines;
Proficiency in project documentation and record-keeping in compliance with regulatory standards;
Ability to prepare clear and concise reports for various stakeholders;
Pro-active and focused on results with strong sense of responsibility and accountability.