Director of Operations m/f

Lausanne Permanent

added 09/07/2021

  • 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.

Job Description

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)

Ghislain de Miribel
Quote job ref

Job summary

Contract Type
Consultant name
Ghislain de Miribel
Job Reference

PageGroup is an equal opportunity employer committed to workforce diversity, both as an employer as well as a recruitment service provider. Each recruitment decision we make for people we hire and people we place into new roles is based solely on the candidates’ knowledge, experience and skills.