Quality Design & Development Engineer II

Description

About us:

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

Position Summary:

The Quality Design & Development Engineer II position is primarily responsible for Design and Development (product development), Regulatory compliance, qualitative and quantitative data analysis, complaint investigation and analysis, Manufacturing support, Training, Gage R&R, and other Quality functions. Additionally, this role is expected to provide input and contribute on Quality System strategies and approach.

Key Responsibilities:

• Perform Design & Development Quality Engineering activities throughout the design, development, and production of medical devices to ensure compliance to company's Design Control procedures and regulatory requirements (specifically FDA 21 CFR 820, ISO 13485, and ISO 14971)
• Create, review and/or approve technical Design & Development documentation to facilitate design, development, and product verification testing of medical devices in collaboration with cross-functional engineering teams
• Create and execute Quality Plans for Product Design & Development projects
• Represent Quality Engineering in technical design and phase end reviews
• Develop and perform Design of Experiments (DOE)
• Develop and validate test methods and Gage R&Rs
• Develop sampling plans and acceptance criteria for product testing and inspection methods using appropriate statistical techniques
• Provide direction in implementing Incoming Inspection plan, First Article Inspection plans, In-Process and Final Product Inspection
• Conduct and support root cause investigations, applying systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues, including CAPAs, nonconformances, and complaints, while developing and implementing corrective and preventative actions for quality system and product-related nonconformances
• Lead and/or participate in risk management activities, develop Risk Management Plans and Reports, perform PFMEAs (Process Failure Mode Effects Analysis) to evaluate and ensure product safety and functionality
• Support customer risk management activities, including FMEAs (Design and Use/Application) and Hazards analysis
• Conduct statistical analysis of data, including normality assessments, data transformations and distribution evaluations, capability analysis, hypothesis testing, ANOVA, and the calculation of confidence and tolerance intervals
• Provide statistical data / trending analysis on CAPA, Complaint, NCMR and other quality metrics
• Responsible for the assessment of component and system level specifications relative to customer needs and product performance specifications
• Perform requirement flow down analysis on critical to quality product performance specifications down to components and processes
• Apply Design for Reliability and Manufacturability tools and techniques
• Support for multiple projects, balancing priorities, and resources to meet both project and management expectations
• Prepare reports required by the project or department management
• Lead and/or participate in reviews and communications with customers
• Develop and perform operational and process qualifications for customer manufacturing processes in conjunction with other engineering departments
• Develop and assist with software validation and verification
• Assist with vendor audits and qualifications
• Participate and/or lead internal audits to assess compliance to FDA and ISO 13485 requirements, as well as the internal Quality System, including investigation observations and findings and reporting
• Member of customer and 3rd party quality audit team. May be required to lead this effort (front room and/or back room)
• Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts
• Complies with company, quality, and safety standards, policies, and procedures

Must Have:

• A Bachelor's degree in a STEM engineering discipline required.
• Minimum 2 years of experience in quality engineering required
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred).
• Demonstrated use of Quality tools/methodologies including Design Control, Risk Analysis (Hazard Analysis), Design FMEA, Process FMEA, Statistical Analysis, and Gage R&R/Test Method Validation
• Knowledge of product development processes and methods
• Strong track record of effectively…