Engineer 3 - Design Quality

JOB SUMMARY

Drive the quality engineering excellence for groundbreaking medical device development programs.  As a Sr Design Quality Engineer, you will drive engineering excellence from concept through commercialization, ensuring both innovation and compliance. This role is a part of the Global Design Assurance Engineering team and combines technical leadership with quality expertise to influence product development, enhance design robustness, and optimize development processes. Working across multiple programs, you'll collaborate with talented engineering teams, lead quality initiatives, and serve as a technical advisor to development teams and senior leadership. Success in this position requires extensive design controls experience, deep engineering knowledge, creative problem-solving, and a passion for developing life-changing medical technologies.  

ESSENTIAL DUTIES

• Drive strategic quality integration during early design phases to accelerate development while maintaining product excellence
• Champion design control processes by providing innovative solutions that balance compliance with design creativity
• Lead comprehensive risk management activities to optimize design decisions and ensure product safety
• Anticipate quality system challenges and guide teams through efficient resolution while maintaining compliance
• Guide implementation of advanced digital quality tools including automated documentation systems and data analytics platforms
• Drive quality strategy in design reviews to ensure robust designs that exceed customer and regulatory requirements
• Lead evaluation and maintenance of Design and Development File documentation to ensure Quality System compliance
• Collaborate across engineering disciplines to ensure effective DFX implementation and design requirements
• Present complex technical analyses to influence strategic decisions with senior leadership
• Mentor junior engineers in quality engineering principles and innovative problem-solving approaches
• Partner with manufacturing teams to ensure successful design transfer and production excellence
• Lead cross-functional initiatives to secure resources and drive program success
• Establish and grow the Design Quality Engineering team while implementing best practices and driving cross functional collaboration under general direction

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelors degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor’s of Science degree or Master of Science degree in Engineering preferred.

Experience

• Minimum 6 years of experience within a regulated industry, medical device experience strongly preferred
• Demonstrated success in design quality implementation and innovation
• Experience with modern quality tools and digital systems

Skills

• Practical application of quality management systems and design control methodologies
• Advanced expertise in risk management tools and failure mode analysis
• Deep understanding of ISO 13485, ISO 14971, and medical device regulations
• Demonstrated interactive skills in, cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team member, team behaviour, and support for engineers, technicians, and management.
• Represents the organization as design quality contact on projects. Interfaces with staff, suppliers, and external subject matter experts to resolve technical issues.
• Strong knowledge and deep understanding of product development processes desired including: design verification, design validation, reliability, design quality implementation, design controls, statistics, test method validation
• Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication
• Excellence in technical documentation and design history file management
• Demonstrated ability to influence cross-functional teams and senior stakeholders
• Strong project management skills with ability to drive multiple programs simultaneously
• Detail-oriented mindset with strong focus on accuracy and thoroughness
• Demonstrated ability to apply latest technological principles to enhance quality processes
• Fluent in English with excellent written and verbal communication skills
• Commitment to continuous learning and staying current with industry advances

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

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