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 organizing tasks, resources, and project documentation in a fast-paced engineering or regulated environment
• Strong verbal and written communication skills including technical report writing and attention to detail
• Ability to work with a wide variety of functional areas including R&D, Manufacturing, and QA, accomplishing results with minimal guidance.
• Proficient in using computer systems, particularly with Microsoft Office applications.
• Must be able to read, write, and speak fluent English

Good to have:

• Quality certification(s) (e.g., ASQ CQE, QCI, Six Sigma, etc.).
• Extensive experience with medical device QSRs in design control and production environments
• Thorough understanding of regulatory requirements for Class II and III medical devices, including FDA 21 CFR Part 820, ISO 13485, and ISO 14971, with hands-on experience applying design controls, risk management, and documentation practices
• Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints.

Salary Range: 85,000 to 100,000 based on experience and skills

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.