About us:

For over three decades, Cirtec Medical has been a leading provider of manufacturing solutions for complex Class II and III medical devices. We specialize in providing comprehensive services from design and development to manufacturing and finished device assembly. Our expertise spans active implants and neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components.

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 challenge, you may be a perfect fit for our team!

Position Summary:

The Principal Catheter Quality Engineer will develop, establish, and maintain quality engineering methodologies, systems and practices which meet customer and regulatory requirements. This role will be focused on leading quality engineering support to the new product development process, operations/production, and quality systems. This individual will also serve as the lead Quality representative to improve awareness, visibility, and communication on quality initiatives to support site and corporate quality goals and priorities.

Key Responsibilities:

• This position may have direct-reporting responsibilities for daily activities of site Quality personnel. This position may be the backup to site management representative.
• Provide Quality Engineering support for engineering product development and sustained manufacturing of catheters
• Provide direction in implementing Incoming Inspection, First Article Inspection, In-Process and Final Product Inspection plans
• Develop and justify appropriate sampling plans with characterization of test/inspection methods.
• Author, review and/or approve documentation for Design Control activities for Design and Project Phase Reviews as well as Product Verification testing in cooperation with cross-functional engineering teams per project requirements.
• Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments

Must Have:

• Bachelor of Science, preferably in biomedical, mechanical, or materials engineering discipline.
• 10 years minimum experience in medical device environment, or combination of education and relevant work experience.
• Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
• Must possess excellent verbal communication, organizational and management skills

Good to have:

• Catheter experience preferred.
• Minitab experience desirable.

Salary Range: The pay range for this role is $125,000-187,000. The successful candidate’s starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions.

Cirtec Medical Corporation considers everyone 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 its related companies fully endorse equal opportunity. 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 an enjoyable 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 stage of your career and life. 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.