Medical Device Project Lead-Development, Contract, Switzerland

Your Role:

Leading or supporting technical activities within development of parenatal delivery systems - eg drug/device combination products and medical devices.

- Deliver project according to project milestone plans
- Plan and lead technical activities
- Manage technical development activities
- Collaborate with internal stakeholders and project teams
- Lead collaboration with external partners for developmentMonitoring of work progress (According to plan)
- Monitoring, support and challenging of technical development
- Test and verification work
- Monitor development and implementation of manufacturing processes
- Coordinate and monitor technical documentation
- Compile design control documentation remediation
- Contribute to high quality design history file

Your Experience:

- Masters Degree in Science/Engineering/Medical Engineering
- Fluency in English
- 8+ years Pharmaceutical industry
- Leading packaging/device/combination product projects
- Remediation projects
- Managing external suppliers
- Communication/conflict solving skills
- Technical knowledge in primary containers eg syringes/cartridges
- Understanding of Human Factors Engineering and Risk Management
- Understanding of clinical studies processes/requirements
- Understanding of pharmaceutical development

Professional Experience:
The successful candidate for this position will lead or support technical activities within the development of parenteral delivery systems
An ideal candidate would have a relevant degree in engineering and at least 8 years of experience in a similar area, including:

- Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive);
- DHF compilation;
- Experience in pharmaceutical companies
- Experience in leading packaging/device/combination product projects
- Experience in remediation projects;
- Product design/Design for manufacture
- Experience of managing external suppliers;
- Good communication and conflict solving skills;
- Good technical knowledge in primary containers, eg syringes and cartridges
- General understanding of Human Factors Engineering and Risk management
- Good understanding of clinic studies processes and requirements.
- Good understanding of pharmaceutical development in general.

Main Tasks:

- Deliver project according to plan at project milestones;
- Plan and lead technical activities;
- Manage technical development activities in collaboration with internal stakeholders as well as in the projects teams;
- Lead the collaboration with external development partners
- Monitor work progress according to plan
- Monitor, support and challenge technical development as well as test and verification work
- Monitor development and implementation of manufacturing processes
- Coordinate and monitor technical documentation
- Compile Design Control documentation remediation and contributing to a high quality Design History file.

Education:
Master degree in Science/Engineering or Mechanical Engineering or University level Engineering education.

Language:
Excellent skills in English language are required.

We welcome applications of consultants' who match most of the above requirements and are available on a short notice. There is a competitive Hourly rate available for the contract; alternative market rates are also welcome.

We hope the role will be of interest to you and understand that further information may be required before making an application to the end client, please feel free to send either your full name, contact details or a complete CV via this website and I will endeavour to get back to you with further information on the role and answer any questions you may have.

Kind regards,

Serena Edith Alpi

Michael Bailey Associates

Job code: 110730

Key words: Medical Device, Project lead development, medical devices, monitoring, regulations, FDA 21, CFR 820, Risk Management, Human Factors Engineering, DHF compilation, Design History File compilation, English, Pharmaceutical, Contract, Basel, Switzerland

Michael Bailey International is acting as an Employment Business in relation to this vacancy.