Design Quality Assurance Engineer 

About the Role
This is an exciting opportunity for a Design Quality Assurance Engineer  to join a cross-functional team within a leading organization’s cardiology division. The successful candidate will support a major new acquisition integration and product development program with high visibility, offering excellent growth potential, acquisition integration experience, and a broad perspective in the medical device industry.

The engineer will provide quality engineering support to acquisition integration, product development, and sustaining projects for both current clinical and future commercial products. They will develop, establish, and maintain quality-engineering methodologies, systems, and practices that meet company, customer, and regulatory requirements.

The Design Quality Engineer will serve as a Quality representative to promote awareness, visibility, and communication on quality initiatives in support of departmental, functional, site, and corporate quality goals.

This role follows a hybrid work model, requiring employees to be in the local office four days per week.
This position is not eligible for relocation assistance or visa sponsorship.

Key Responsibilities:

• Support verification, validation, and usability planning and testing to meet or exceed internal and external requirements.

• Develop, update, and maintain the Design History File; collaborate with R&D on Design Input/Output documentation (Product Specifications, Component Specifications, Prints).

• Work within a cross-functional team to identify and implement effective controls, supporting product development through commercialization.

• Support regulatory submissions to notified bodies.

• Develop, update, and maintain product and/or software risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs).

• Develop, update, and maintain usability files: plan, participate in usability assessments, and generate/update usability documentation.

• Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues collaboratively with the team.

What We’re Looking For:

Required Qualifications:

• Bachelor’s degree in Mechanical, Electrical, or Biomedical Engineering (or equivalent qualification).

• Minimum of 3 years’ experience in design assurance, quality, or a related role within the medical device or other regulated industry.

• Strong understanding of ISO 13485 / Quality System Regulations and ISO 14971 / Risk Management.

• Self-motivated with a passion for solving problems and driving results.

• Excellent communication and presentation skills.

Preferred Qualifications:

• Understanding of medical electrical equipment, cybersecurity, and software design controls.

• High attention to detail, accuracy, and completeness.

• Strong organizational and planning abilities with a drive for results.

• High-energy problem solver capable of driving issues to closure.

• Ability to collaborate effectively within global cross-functional teams (R&D, Process Development, Manufacturing, etc.).