Senior Design Assurance Engineer - Mitral Valve Devices

4C Medical Tech; Don Mariano Marcos; On-site; PHP 900,000 - 1,100,000; Full time

Benefits offered by this job

Medical

Dental

Vision

FSA

Basic Life

401(k) Retirement Plan

Paid Holidays

PTO

Maternity/Paternity paid leave

Job summary

4C Medical Tech is seeking a Senior Design Assurance Engineer to lead design assurance activities across the product lifecycle and ensure compliance with FDA, ISO, and EU standards. The role involves managing DHF, risk management per ISO 14971, and supporting regulatory submissions with cross-functional teams.

You will mentor junior engineers and drive improvements in design controls, risk management, and documentation quality, while collaborating with R&D, Clinical, Operations, and Regulatory

Qualifications

• Experience in medical device development and design assurance.
• Familiarity with FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR.
• Strong technical writing and documentation skills.
• Ability to lead cross-functional teams and mentor junior engineers.

Responsibilities

• Lead design assurance activities throughout the product lifecycle.
• Own design controls, including inputs/outputs, reviews, verification, validation, and transfer.
• Maintain Design History Files (DHF) to be audit-ready.
• Author and review risk management documentation per ISO 14971.
• Support regulatory submissions and audits.
• Provide QA support to R&D, Clinical, Operations, and Regulatory Affairs.
• Drive continuous improvement across design assurance and product development.

Skills

Design controls

Risk management

Technical writing

Project management

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Minitab

Nitinol processing basics

Job description

4C Medical Tech is seeking a Senior Design Assurance Engineer to lead design assurance activities across the product lifecycle and ensure compliance with FDA, ISO, and EU standards. The role involves managing DHF, risk management per ISO 14971, and supporting regulatory submissions with cross-functional teams.

You will mentor junior engineers and drive improvements in design controls, risk management, and documentation quality, while collaborating with R&D, Clinical, Operations, and Regulatory