JD-003 Design & Development Manager 2022_001
Education
Bachelor's degree in engineering or equivalent.
Experience
>=2 years
Skills
- Knowledge of artificial intelligence applications in the healthcare sector.
- Communicative, organised, resolute and goal oriented.
Responsibilities
- To coordinate the product design and development processes.
- To manage the product technical aspects with suppliers and subcontractors.
- To support the monitoring of the medical device during its entire life cycle.
- To verify that the developed products meet the requirements of the applicable regulations.
- To prepare the design and development documentation.
- To provide the COO with all the information required for the drafting of the medical device technical documentation.
- To support the maintenance of the risk management report.
- To notify the JD-004 Quality Manager or the JD-005 Technical Manager & Person Responsible for Regulatory Compliance (PRRC) of any non-conformity, deviation, need or abnormality.
- To request training from the Quality Manager and attend said training.
- To notify the existence of non-conforming products or materials to the JD-004 Quality Manager for their correct identification, documentation, segregation, evaluation and control.
| Approved by | Accepted by |
|---|---|
E-Signature (Appfire integration):  Andy Aguilar 92D8162DF4A424FB2926AB5A75420880 Signer name: Andy Aguilar Signing time: Sat, 24 Sep 2022 00:00:00 GMT Reason: Approved | E-Signature (Appfire integration): Gerardo Fernandez 59ED9928036D0138DFED5B8EDF2B32B9 Signer name: Gerardo Fernandez Signing time: Sat, 24 Sep 2022 00:00:00 GMT Reason: Accepted |
| JD-001 General Manager | JD-003 Design & Development Manager |
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-003, JD-004
- Approver: JD-001