Design Quality Eng Supervisor

JOB TITLE:  Design Quality Engineering Supervisor

JOB SUMMARY

Lead the quality strategy and execution for groundbreaking medical device development programs that improve patient lives. As a Design Quality Engineering Supervisor, you will lead the Design Quality Engineering team and drive engineering excellence from concept through commercialization, ensuring both innovation and compliance individually and for a team. This role combines team management with technical leadership and 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

• Establish and grow the Design Quality Engineering team while implementing best practices and driving cross functional collaboration under general direction
• 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 History 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
• Provide leadership for the functions junior Quality engineers in development and adherence to 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

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 of Science Degree in Engineering, preferred.

Experience

• Minimum 6 years of experience within a regulated industry, medical device experience strongly preferred
• At least 1 year of supervisory experience
• Demonstrated success in design quality implementation and innovation
• Experience with modern quality tools and digital systems

Skills

• Mastery 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
• Deep understanding of product development processes including reliability engineering
• Strong command of design verification and validation processes
• 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

JOB TITLE:  Design Quality Engineering Supervisor

JOB SUMMARY

Lead the quality strategy and execution for groundbreaking medical device development programs that improve patient lives. As a Design Quality Engineering Supervisor, you will lead the Design Quality Engineering team and drive engineering excellence from concept through commercialization, ensuring both innovation and compliance individually and for a team. This role combines team management with technical leadership and 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

• Establish and grow the Design Quality Engineering team while implementing best practices and driving cross functional collaboration under general direction
• 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 History 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
• Provide leadership for the functions junior Quality engineers in development and adherence to 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

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 of Science Degree in Engineering, preferred.

Experience

• Minimum 6 years of experience within a regulated industry, medical device experience strongly preferred
• At least 1 year of supervisory experience
• Demonstrated success in design quality implementation and innovation
• Experience with modern quality tools and digital systems

Skills

• Mastery 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
• Deep understanding of product development processes including reliability engineering
• Strong command of design verification and validation processes
• 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

JOB TITLE:  Design Quality Engineering Supervisor

JOB SUMMARY

Lead the quality strategy and execution for groundbreaking medical device development programs that improve patient lives. As a Design Quality Engineering Supervisor, you will lead the Design Quality Engineering team and drive engineering excellence from concept through commercialization, ensuring both innovation and compliance individually and for a team. This role combines team management with technical leadership and 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

• Establish and grow the Design Quality Engineering team while implementing best practices and driving cross functional collaboration under general direction
• 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 History 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
• Provide leadership for the functions junior Quality engineers in development and adherence to 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

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 of Science Degree in Engineering, preferred.

Experience

• Minimum 6 years of experience within a regulated industry, medical device experience strongly preferred
• At least 1 year of supervisory experience
• Demonstrated success in design quality implementation and innovation
• Experience with modern quality tools and digital systems

Skills

• Mastery 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
• Deep understanding of product development processes including reliability engineering
• Strong command of design verification and validation processes
• 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