As a leading provider of innovative technologies for the treatment of Atrial Fibrillation (Afib) and related conditions, electrophysiologists and cardiothoracic surgeons around the globe count on AtriCure to deliver best-in-class solutions that can treat even the most complex cases. Our Isolator® Synergy™ Ablation System is the first and only medical device approved by the FDA for the treatment of long standing persistent Afib, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide, and we are expanding into pain management therapies. We invest in innovation, clinical science, and education to focus on improving lives for our patients’ worldwide.
Reporting to Director of Design Assurance, the Manager of Design Assurance Quality Engineering will be both 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 as well as part of the Quality Leadership team. The latter will mentor and coach DA engineers to be successful in the development of new AtriCure products.
ESSENTIAL FUNCTIONS OF THE POSITION:
- On time quality delivery of assigned product development/sustaining project deliverables, as applicable
- Optimize existing design control processes to maximize efficiencies and continue to identify, plan and execute continuous improvement activities as needed.
- Drive continuous improvements through observation, measurement and root cause analysis/resolution
- Provide subject matter expertise for assigned design control processes to users as necessary.
- Responsible for cross functional collaboration with product development, manufacturing/operations, marketing and regulatory.
- Provide coaching to team members, direct reports and other DA quality engineers respective to investigative methods, risk mitigation techniques, requirements management and other design control related processes/deliverables/techniques (including Six Sigma, FTA, FMEA, HALT, basic stats analysis, etc.)
- 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.
- Ensure commitment to functional excellence and the ability to execute positive changes
- Lead the hiring of top talent for new DA team members
- Coach/mentor DA engineers in the group in areas of development, prioritization of work, tracking of progress of milestones, timely and consistent feedback on performance
- Motivate both members of the development teams they are assigned to as well as the other associates in the DA department to embrace the principles of quality that will ultimately result in products that excel in the market place.
- Provide clear expectations of prioritization and success criteria to associates.
- Assist in gap closure to comply with EU MDR Regulation changes
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
- Regular and predictable worksite attendance
- 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
- Bachelor’s degree required or demonstrated equivalent combination of education, training and experience.
- Minimum of 7 years of experience in an engineering role in the medical device industry
- Minimum of 2 years of experience in support of product development
- Working knowledge in statistical analysis techniques including Reliability analysis
- Experience in test method strategies, development and validation including GR&R
- Ability to motivate a team
- experience in successfully coaching/managing other engineers
- Ability to set direction/vision/strategy and execute
- Experience with risk management methodology
- Knowledge of Design Controls and experience with FDA QSR 21 CFR Part 820, ISO 13485 including EU MDR
- 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%
- 10 years or more experience in an engineering role in Medical Devices
- 5 or more years’ experience supporting Product Development
- 2 or more years’ experience in managing direct reports.
- Experience in processes related to Design Change Control, Design Reviews, Requirements Management
- Certification in ASQ, Six Sigma/Design for Six Sigma
- 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