Quality Design Control Engineer

Temporary Position – Maternity Leave Replacement

Position Overview

The Quality Design Control Engineer is responsible for supporting and leading design control and product quality activities throughout the product lifecycle, ensuring compliance with applicable regulatory requirements, international standards, and company procedures.

Roles and Responsibilities

• Lead and maintain Design Control activities in accordance with ISO 13485:2016, applicable regulatory requirements, and internal procedures, including design changes, impact assessments, design reviews, Verification and Validation (V&V) activities, product configuration management, traceability, and Design History File (DHF) documentation.
• Lead the preparation, review, execution, and documentation of Design Verification and Validation (V&V) activities, including protocols, reports, deviations, and supporting documentation.
• Maintain and continuously update the Risk Management File in accordance with ISO 14971, including risk analyses, risk-control measures, verification of risk-control effectiveness, and benefit-risk assessments, as applicable.
• Ensure that product designs and design changes comply with applicable regulatory requirements, standards, design inputs, specifications, and internal procedures.
• Support design transfer and configuration management, ensuring consistency between approved design documentation, product specifications, manufacturing documentation, and released product configurations.
• Lead and coordinate product-related qualification and validation activities, including sterilization validation, biocompatibility assessments, packaging and transportation validation, shelf-life activities, and preclinical studies, as applicable.
• Support facility, equipment, and process qualification and validation activities, as required.
• Collaborate cross-functionally with R&D, Manufacturing, Regulatory, Clinical, and Operations teams to ensure that quality and regulatory requirements are appropriately incorporated throughout product development and implementation of design changes.
• Support investigations, CAPAs, nonconformances, and change-control activities where design- or product-related assessment is required.

Qualifications and Preferred Skills

• B.Sc. in Biomedical Engineering, Mechanical Engineering, Life Sciences, or another relevant scientific or engineering discipline.
• Minimum of 3 years of experience in Design Control and/or Quality Engineering within the medical device industry. Experience with cardiovascular or other Class III interventional medical devices is preferred.
• Strong knowledge of and practical experience with ISO 13485 and ISO 14971.
• Familiarity with applicable medical device standards, including ISO 10993, ISO 11135, ISO 11607, and other relevant product-specific standards.
• Hands-on experience with design changes, risk management, V&V activities, technical documentation, and DHF maintenance.
• Strong technical understanding and the ability to evaluate the potential impact of design and manufacturing changes on product safety, performance, and regulatory compliance.
• Excellent attention to detail, accuracy, and technical documentation skills.
• Strong communication and cross-functional collaboration skills.
• Good written and verbal English communication skills.
• Ability to work independently, manage multiple priorities, and collaborate effectively within a multidisciplinary team.