Senior Design Assurance Quality Engineer

POSITION SUMMARY:

This position will be part of one or more product development teams where they will be responsible for contributing to the on-time development of high-quality products. This position will also be responsible for supporting and leading activities related to trending quality field performance. This position will be responsible for subsequent improvements for marketed products and optimization of design control processes as needed.

ESSENTIAL FUNCTIONS OF THE POSITION:

• On time quality delivery of assigned product development team deliverables
• Ensure assigned design control procedures are compliant with FDA, GMP, ISO and other applicable standards and regulations.
• Optimize existing processes to maximize efficiencies and continue to identify, plan and execute continuous improvement activities.
• Drive continuous improvements through observation, measurement and root cause analysis/resolution
• Develop new processes which support speed, cost reductions and quality improvements
• Provide subject matter expertise for assigned processes to users as necessary.
• Responsible for cross functional collaboration with R&D, manufacturing operations, marketing, sales, regulatory and clinical functions
• Provide coaching respective to investigative methods, risk mitigation techniques, DOE, statistical analysis, Reliability and other related techniques (including Six Sigma, FTA, FMEA, HALT, etc.)
• Provide guidance for development of manufacturing test/evaluation methods and process validation
• Provides investigative support/leadership for product quality issues
• Work with product development teams to help cascade requirements from VOC through manufacturing requirements and link to production controls
• Work with product development teams on timely use of Risk Management activities including supporting and leading FMEAs and essential requirements analysis including standards review and evidence of conformity.
• Serve as technical resource for problem investigations to guide root cause analysis and corrective action development.
• Provide mentorship to junior level design assurance engineers in design control and product development
• Ensure commitment to functional excellence and the ability to execute positive changes

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Regular and predictable work performance
• Ability to work under fast-paced conditions
• Ability to make decisions and use good judgement
• Ability to prioritize various duties and multitask as required
• Ability to successfully work with others
• Additional duties as assigned

BASIC QUALIFICATIONS:

• Bachelor’s degree in Engineering required or demonstrated equivalent combination of education, training and experience.
• Minimum of 5 years of experience in an engineering role in the medical device industry
• Experience with business process development
• Working knowledge in statistical analysis techniques including Reliability assessment
• Experience in test method strategies, development and validation including GR&R
• Experience with risk management methodology
• Knowledge of Design Controls and experience with FDA QSR 21 CFR Part 820, and ISO 13485
• Ability to create and manage key internal and external partnerships
• Excellent written and verbal communication skills
• High level of attention to detail
• Familiar with product safety and standards
• Ability to demonstrate proficiency in issue resolution.
• Ability to multi-task and work with little direction
• Ability to manage multiple priorities
• Familiar with product safety standards
• Ability to travel 10%

PREFERRED QUALIFICATIONS:

• 7 years or more experience in an engineering role in Medical Devices
• 5 or more years’ experience working with Product Development
• Experience in processes related to Design Change Control, Design Reviews, Requirements Management
• Certification in ASQ, Six Sigma/Design for Six Sigma

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed
• Ability to occasionally bend and push/pull as needed
• Ability to pass pre-employment drug screen and background check

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