Associate Director - Global Device Introduction & Maintenance
Ref#: CH-FER-0104 / R0008306
In our Headquarter in St-Prex/Lausanne (Switzerland), we are looking for a:
The Global Device Introduction & Maintenance team is responsible for:
· Ensuring input on design for manufacture and supply chain to global medical device projects
- Leading design transfer / tech transfer in global medical device projects.
- Maintaining commercial medical devices (design changes, DHF, process…), including managing agreed change projects and investments.
- Device supplier relation management for selected suppliers (Third Party Manufacturers / CMO’s).
Your main responsibilities will be:
- Lead & manage the department, including:
- People management
- Budgeting and follow-up
- Resource management
- Stakeholder management
- Lead & manage agreed global device maintenance projects, from project initiation to closure (e.g. larger design changes, design / tech transfer to other suppliers, etc.), including
- Management of significant external costs and handling of substantial equipment investments.
- Awareness to identify drug primary packaging / compatibility aspects in connection with changes and ensure that relevant responsible function areas are involved to handle these.
- Ensure pro-active maintenance of commercial global devices
- Managing commercial medical device overview
- Managing smaller design changes and support on manufacturing process issues
- Ensuring DHF maintenance (including risk management)
- Supporting complaint investigations & technical questions
- Provide input to global device development projects:
- Ensure timely consideration of supply chain setup / manufacturing strategy in close collaboration with Product Supply and rest of R&D
- Design for manufacturing (including robust design and manufacturing processes) in close collaboration with TPM’s / CMO’s.
- Holds a M.Sc. or Ph.D. in a relevant discipline (typically engineering or natural science).
- At least 10 years experience in medical device development or production, with demonstrated project and people management experience.
- Strong working knowledge within medical device design control, design changes, manufacturing processes (validation, QC, packinging), CAPA’s, statistical methods.
- Experience with managing and collaborating effectively with external third party manufacturers / CMO’s
- Preferable: experience with drug delivery medical devices, including drug-device combination products, drug CMC interface aspects, and GXP regulated work within the pharmaceutical industry.
- Excellent leadership skills
- Strong ability to work effectively across organizational boundaries in a large organization, manage stakeholders, and influence in a collaborative way.
- Good communication skills, excellent command of English (spoken and written), and preferably French.
- Ability to work well both as an integral part of larger project teams but also as a self-starter.
- Effective in, and motivated by, working in a multicultural and interdisciplinary environment.
A challenging and exciting job in an international company with great development possibilities, a competitive salary and an entrepreneurial and open work environment, in which your leadership will be valuable and make a difference.
Not yet ready to apply? Sign up to be notified of future opportunities
Serendi is a recruitment service provider with its headquarters in Switzerland. Our clients are large Swiss or international companies.
We manage the entire recruitment process for our client companies - including sourcing of candidates. Candidates are selected based on how well their experience and qualifications match our clients position requirements.
We source and screen thousands of candidates and applications per year and recommend the most qualified candidates to our clients.
If you want to apply for one of the open positions with one of our clients you can do this through this website. Please enter the required data and upload your CV. Our recruitment consultants will screen your application very thoroughly. You will receive via email constant updates on the status of your application. Please apply for each position you are interested in.