Senior Engineer – Design Quality Assurance

Role Overview

• Drive the design & execution of Production Release Process project for components & finished devices
• Lead and implement complex projects including quality improvement initiatives
• Sets direction for cross-functional teams and drives towards compliant and efficient solutions to complex problems
• Lead Process/Design Risk Analysis
• Lead multiple product Design Control activities for new product development efforts
• Provide leadership in understanding of the quality regulations to other disciplines
• Support Process/Design Validation/Verification activities and approach including software validation
• Lead implementing limited cost of quality concepts, including cost of quality, data collection, & reporting
• Support Manufacturing Engineering in the creation of DMR, DHR, routes, and bills of material, print changes, and specifications for in-house / external manufacturing
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.

Requirements

• Bachelor’s Degree in Engineering required
• Minimum of 5 years of experience in Quality Engineering within an FDA regulated medical device manufacturing environment
• Up to 10% domestic travel
• Strong working knowledge of technical problem solving via Six Sigma type tools to analyze, drive root cause, and solve problems
• Proven track record in Sustaining Engineering, support of commercialized products and Post Market Surveillance
• Strong working knowledge of statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab
• Strong working knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO 13485, ISO 14971, ISO 11135, EUMDR and Human Factors
• Strong written and oral communication skills
• Ability to thrive in a fast-paced, dynamic and deadline-driven environment
• Well organized, flexible self-starter, team motivated and excellent at prioritizing and multi-tasking
• Skilled in presentation development and public speaking.

Benefits

• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehensive medical, dental, vision coverage effective on start date
• 24/7 Employee Assistance Program
• Free live and on-demand Wellbeing Programs
• Generous Paid Vacation and Sick Time
• Paid Parental Leave and Adoption Assistance*
• 12 Paid Holidays
• On-Site Child Daycare, Café, Fitness Center**