- Medical device - Class 3 - ISO13485 - startup
- Manufacturing, design transfer, process validation, supply chain management
About Our Client
Our client is a start-up specialised in Medical Devices - Class 3, based in Lausanne.
1) Operations Management
- In collaboration with the COO, the Director of Product Development, the Project Managers and the QA Manager, supervises the production of company pipeline products.
- Owner of following processes of the Quality Management System: Manufacturing, Transfer to Manufacturing, Suppliers Management, Purchasing, Order Handling and Delivery, Storage and Product Preservation, Equipment Qualification and Process Validation.
- Leads local activities related to products and manufacturing technology transfers to subcontracted manufacturers.
- Manages operations resources to effectively manufacture products in an environment that is fully compliant with GMP, ISO standards and applicable regulatory requirements.
- Evaluates subcontractors and preparing necessary documents that define collaboration: Quality agreement, services agreement, consultancy agreement & non-disclosure agreement.
- Ensures adequate inventories of raw materials & finished goods as well as tools, fixtures, suppliers are properly maintained.
- Ensures adequate finish goods distribution to final users.
- Responsible for establishing and maintaining adequate infrastructure and material resources relative to operations.
- Evaluate overall manufacturing performance by gathering, analyzing and interpreting data and metrics.
- Supports COO in preparing annual budget and in following-up monthly spending by providing accurate requests.
- Prepares and finalizes Processes Validation for products towards regulatory clearance and and/or CE-Mark.
- Perform supplier audits.
2) HR Management
- Responsible for establishing Quarterly and Annual Objectives for his direct reports. Responsible for evaluation of his direct reports on a quarterly and annual basis, providing feedback when improvement is required.
- In collaboration with the management defines the appropriate organizational structure and develops skills by encouraging training required to achieve the company objectives.
- Creates, maintains, and promotes a work environment of participation, open communication and teamwork.
- Responsible for maintaining HR files up to date according to applicable procedures.
3) Professional responsibility
- All activities performed in accordance with Quality and Regulatory guidelines.
- Maintain professional curiosity and knowledge of advancement and development in the field.
- Willingness to acquire new knowledge specific to field through continuing education.
The Successful Applicant
- Master degree or Engineering degree (technical school) in Mechanical Engineering, Microengineering, Biomedical Engineering or Physics with at least 5 to 7 years of experience in leading a team, leading projects, preparing budgets.
- At least 5 years of experience in a medical device company, with direct experience of design transfer to manufacturing, manufacturing validation and external suppliers and sub-contractors management.
- Good knowledge of EU requirements relative to development and production of active implantable devices (ISO 13485, MDR EU 2017/745).
- Knowledge of US requirements relative to development and production of active implantable devices (21 CFR 820) is an asset.
- Fluent in French and English (written and spoken).
What's on Offer
You are passionate candidate and are available to grow your carreer in start-up with a lot of potential ! (CV in PDF format)