Beschreibung
Development Support & Design Risk EngineerLocation: Zürich
Duration: 10 months with possible extension
The position is supporting Product Development in different types of projects to ensure that all deliverable are established on time and in the required quality. The Position is also reviewing the Engineering Change Orders to make sure that quality relevant aspects are covered. Furthermore it needs to ensure that the Design Risk Management process is followed and support the management of standards and guidance's.
Overall responsibilities
- Ensure a compliant execution of development projects by PD and Operations (in collaboration with the Site Quality Managers).
- Ensure that Design Control relevant deliverable are established on time and in the required quality.
- Act as an advisor to development project members to help them find a pragmatic way of achieving compliance.
- Ensure the proper handover of the projects from the development teams to the sites from a quality perspective (Design Transfer)
- Approve / Review Change Requests and other technical documentation as described in the DC process
- Participation in Design Review meetings and review of the Design Review documentations.
- Review and support the Design Risk Management execution.
- Support the on boarding of new suppliers in product life cycle management projects.
- Support to ensure the design transfer is performed according to the QMS regulation.
- Pragmatic but compliant application of the PLCM process.
- Ensuring the Risk Management process is followed.
- Improvement of the Medical Device know how in the project teams.
- Customer orientation.
- Competence in development as a key asset for creating acceptance and momentum in Development
- Ability to make self-reliant decisions considering the compliance risks.
Key Competencies for this Role:
- Aligning performance for success
- Delivery of Results, Planning and Organising
- Raising the Bar, Gaining Commitment
- Managing Conflict, Quality Orientation
- Decision Making, Initiating Action
Your Profile
- Higher education (preferably engineering or science)
- 8 years of experience in the Medical Device industry (preferably Development or Quality Management) and basic knowledge of ISO 13485, 21 CFR 820, ISO 14971.
- Consequent and efficient, compliant and pragmatic. The position will always be on the line to decide what is acceptable from a Quality Management perspective and what not.
- The position holder must be strong in discussion with the TPL (Technical project leader) and whitstand the tendency to skip necessary steps or do them unsufficiently. She must therefore be capable of working cross-functionally.
- Experience from interacting with project managers under pressure, from cross-functional work and a basic understanding from all functions in the company. Experience in Product Development and leading workshops.
- Experienced in effective and compliance design transfer of new products and technologies in production environment
If you think that you can fulfil the requirements above and if you are keen to discuss the general job market situation in Switzerland, please do not hesitate to get in contact with me.
Best Regards
Sabina Keel