POSITION SUMMARY:This position will be part of one or more product development teams where they will 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
Provide coaching respective to investigative methods, risk mitigation techniques, Reliability analysis, design control, testing strategies and measurement system analysis (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 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 7 years of experience in an engineering role in the medical device industry
Experience in development of and linking product requirements from VOC through to design output and production controls
Experience with business process development
Experience in Reliability definition, testing and assessment
High level of knowledge/experience in statistical analysis techniques
High level of knowledge/experience in test method strategies, development and validation including GR&R
High level of knowledge/experience with risk management methodology using ISO 14971
High level of knowledge/experience 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 effectively mentor and coach others
Ability to travel 10%
PREFERRED QUALIFICATIONS:
10 years or more experience in an engineering role in Medical Devices
7 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
