Design Quality Engineer II

Job summary:

Drive the quality engineering excellence for groundbreaking medical device development programs.  The Design Quality Engineer (DQE) contributes to and ensures completion of work required to deliver quality product designs that ensure both innovation and compliance. This role is a part of the Global Design Assurance Engineering team and combines technical skills with quality expertise. Supports medical device and laboratory products with mechanical, electrical, and software elements. Uses the combination of technical and quality knowledge to influence product development and enhance design robustness across multiple programs. 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:

• Work in a cross-functional, collaborative, team-based environment to drive product quality during design and development including the completion of project design quality deliverables.
• Champion design control processes by providing innovative solutions that balance compliance with design creativity specific to specification development, verification, validation, human factors, and process qualification.

• Anticipate quality system challenges and guide teams through efficient resolution while maintaining compliance
• Drive quality strategy in design reviews to ensure robust designs that exceed customer and regulatory requirements
• Facilitate and support risk management activities such as FMEA and hazard analysis.
• Follows department processes and regularly makes recommendations for processes and procedural improvements.
• Drives root cause analysis for deviations and quality design issues to solve moderately complex problems and recommend solutions. 

• Performs investigation for quality issues and drives product and systemic improvements through CAPA and change management.
• Provides quality guidance for technical reports, charts, and graphs to support project recommendations and responds to questions from staff members and management.

• Supports data analysis and decision making through robust statistical methods.

OTHER DUTIES AND RESPONSIBILITIES

• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
• May contribute to the development of procedures for technical or business processes.

MINIMUM QUALIFICATION REQUIREMENTS

Education:

• Bachelor’s 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 2 years experience.
• Two years of GMP manufacturing experience required.

Skills:

• 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 behavior, 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.
• Follows technical specification requirements and provides input on technical procedures on various processes that impact multiple disciplines.
• Knowledge of product development processes desired including: reliability growth, 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.
• Experience in quality management systems and design control methodologies
• Expertise in risk management tools and failure mode analysis
• Understanding of ISO 13485, ISO 14971, and medical device regulations
• Strong command of design verification and validation processes
• Excellence in technical documentation and design history file management
• Demonstrated ability to influence cross-functional teams
• 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 summary:

Drive the quality engineering excellence for groundbreaking medical device development programs.  The Design Quality Engineer (DQE) contributes to and ensures completion of work required to deliver quality product designs that ensure both innovation and compliance. This role is a part of the Global Design Assurance Engineering team and combines technical skills with quality expertise. Supports medical device and laboratory products with mechanical, electrical, and software elements. Uses the combination of technical and quality knowledge to influence product development and enhance design robustness across multiple programs. 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:

• Work in a cross-functional, collaborative, team-based environment to drive product quality during design and development including the completion of project design quality deliverables.
• Champion design control processes by providing innovative solutions that balance compliance with design creativity specific to specification development, verification, validation, human factors, and process qualification.

• Anticipate quality system challenges and guide teams through efficient resolution while maintaining compliance
• Drive quality strategy in design reviews to ensure robust designs that exceed customer and regulatory requirements
• Facilitate and support risk management activities such as FMEA and hazard analysis.
• Follows department processes and regularly makes recommendations for processes and procedural improvements.
• Drives root cause analysis for deviations and quality design issues to solve moderately complex problems and recommend solutions. 

• Performs investigation for quality issues and drives product and systemic improvements through CAPA and change management.
• Provides quality guidance for technical reports, charts, and graphs to support project recommendations and responds to questions from staff members and management.

• Supports data analysis and decision making through robust statistical methods.

OTHER DUTIES AND RESPONSIBILITIES

• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
• May contribute to the development of procedures for technical or business processes.

MINIMUM QUALIFICATION REQUIREMENTS

Education:

• Bachelor’s 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 2 years experience.
• Two years of GMP manufacturing experience required.

Skills:

• 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 behavior, 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.
• Follows technical specification requirements and provides input on technical procedures on various processes that impact multiple disciplines.
• Knowledge of product development processes desired including: reliability growth, 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.
• Experience in quality management systems and design control methodologies
• Expertise in risk management tools and failure mode analysis
• Understanding of ISO 13485, ISO 14971, and medical device regulations
• Strong command of design verification and validation processes
• Excellence in technical documentation and design history file management
• Demonstrated ability to influence cross-functional teams
• 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 summary:

Drive the quality engineering excellence for groundbreaking medical device development programs.  The Design Quality Engineer (DQE) contributes to and ensures completion of work required to deliver quality product designs that ensure both innovation and compliance. This role is a part of the Global Design Assurance Engineering team and combines technical skills with quality expertise. Supports medical device and laboratory products with mechanical, electrical, and software elements. Uses the combination of technical and quality knowledge to influence product development and enhance design robustness across multiple programs. 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:

• Work in a cross-functional, collaborative, team-based environment to drive product quality during design and development including the completion of project design quality deliverables.
• Champion design control processes by providing innovative solutions that balance compliance with design creativity specific to specification development, verification, validation, human factors, and process qualification.

• Anticipate quality system challenges and guide teams through efficient resolution while maintaining compliance
• Drive quality strategy in design reviews to ensure robust designs that exceed customer and regulatory requirements
• Facilitate and support risk management activities such as FMEA and hazard analysis.
• Follows department processes and regularly makes recommendations for processes and procedural improvements.
• Drives root cause analysis for deviations and quality design issues to solve moderately complex problems and recommend solutions. 

• Performs investigation for quality issues and drives product and systemic improvements through CAPA and change management.
• Provides quality guidance for technical reports, charts, and graphs to support project recommendations and responds to questions from staff members and management.

• Supports data analysis and decision making through robust statistical methods.

OTHER DUTIES AND RESPONSIBILITIES

• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
• May contribute to the development of procedures for technical or business processes.

MINIMUM QUALIFICATION REQUIREMENTS

Education:

• Bachelor’s 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 2 years experience.
• Two years of GMP manufacturing experience required.

Skills:

• 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 behavior, 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.
• Follows technical specification requirements and provides input on technical procedures on various processes that impact multiple disciplines.
• Knowledge of product development processes desired including: reliability growth, 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.
• Experience in quality management systems and design control methodologies
• Expertise in risk management tools and failure mode analysis
• Understanding of ISO 13485, ISO 14971, and medical device regulations
• Strong command of design verification and validation processes
• Excellence in technical documentation and design history file management
• Demonstrated ability to influence cross-functional teams
• 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.