Product Engineering Development Manager — Regulatory & QA Lead

Private Advertiser; Mimaropa; On-site; PHP 600,000 - 1,000,000; Full time

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

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.