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 and optimization of core design control business processes.

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 manufacturing operations, marketing, sales, regulatory and clinical functions
• May include coaching and training respective to investigative methods, risk mitigation techniques and general safety (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
• 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 judgment
• 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 from an accredited college or university or demonstrated equivalent combination of education, training and experience
• Minimum of 3 years of experience in an engineering role in the medical device industry
• Experience with quality system 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 travel 10%

PREFERRED QUALIFICATIONS:

• 5 years or more experience in an engineering role in Medical Devices
• 3 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

#LI-KN1