PRODUCT ENGINEERING DEVELOPMENT ASSISTANT MANAGER

Private Advertiser

Mimaropa

On-site

PHP 600,000 - 1,000,000

Full time

9 days ago
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Job summary

Private Advertiser in the Philippines is seeking a design and development specialist to oversee the design and development stages, ensure completion, and provide product specifications during development.

You will review and approve test protocols, maintain EC Declaration of Conformity, perform risk management, manage BOM/BOO, IO tables, and technical files, and handle label templates and artwork, with special ability in planning, testing, evaluation and reporting.

Qualifications

  • Ability to plan, execute, and monitor design development activities.
  • Knowledge of MDR/MDD documentation processes is a plus.
  • Strong analytical and documentation skills.

Responsibilities

  • Oversee design and development stages to ensure completion.
  • Provide product specifications during development phase.
  • Receive and evaluate change requests from customers.
  • Prepare MDR/MDD documentation.
  • Review and approve test protocols and reports.
  • Review and approve Product Engineering Change Orders related to procedural changes.
  • Review and approve risk management program implementation during development.
  • Review and approve device settings for parts, WIP, and product codes.
  • Review and approve Product Standard Charts establishment and updates.
  • Review and approve BOM and BOO documentation.
  • Review and approve creation and maintenance of technical files.
  • Review and approve label printing templates and artwork.
  • Review and approve EC Declaration of Conformity processes.
  • Review and approve design verification processes.
  • Review and approve IO table collection and updates.
  • Review and approve literature data collection and analysis.
  • Review and approve clinical data evaluation and updates.
  • Other responsibilities assigned by superior
  • With knowledge in planning, testing, evaluation and reporting

Skills

Planning
Testing
Evaluation
Reporting

Job description

1. Overview the design and development stages to ensure it is performed or completed.

2. Provide product specification during development phase.

3. Receive notification for request of change from customer.

4. Prepare documents for MDR/MDD.

5. Review and approve test protocols and reports.

6. Review and approve the initiation and maintenance of Product Engineering Change Orders related to procedural changes.

7. Review and approve the implementation of the risk management program throughout the development process.

8. Review and approve the settings for parts, WIP, and product codes.

9. Review and approve the establishment, modification, updating, and maintenance of Product Standard Charts.

10. Review and approve the establishment and maintenance of Bills of Materials (BOM) and Bills of Operations (BOO).

11. Review and approve the creation, modification, updating, and maintenance of technical files.

12. Review and approve the maintenance and control of label printing templates and artwork.

13. Review and approve the evaluation and maintenance of the EC Declaration of Conformity.

14. Review and approve design verification processes.

15. Review and approve the collection of design transfer requirements for development and the establishment of the Input/Output (IO) table.

16. Review and approve the revision and updating of the IO table throughout the development cycle.

17. Review and approve the conduct of literature research, appraisal, and analysis of relevant data.

18. Review and approve the evaluation and updating of clinical data.

19. Other responsibilities assigned by superior

SPECIAL ABILTY:

With knowledge in planning, testing, evaluation and reporting

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