Sr. Tool Design Engineer

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 Sr. Tool Design Engineer is primarily responsible to provide support to engineering, production, and quality while adhering to quality system requirements. For developing and improving tooling and fixtures from concepts and sketches into drafting prints while complying with industry drafting standards. Activities completed in this position must be implemented in accordance with Good Manufacturing Practices, Good Documentation Practices, ISO, and FDA requirements.

Key Responsibilities:

• Generate 3D models and Engineering drawings.
• Create detailed tooling, gage, and fixture engineering drawings independently and with input from the subject matter expert or engineer.
• Review engineering drawings to ensure adherence to specifications and standards.
• Perform dimensional stack-ups, adjusting as needed for best-fits.
• Manage workload to support various departments.
• Review external customer CAD files for drawing requirements and modify as needed to support internal customers.
• Initiate and or review ECO's for Drawing releases and revisions.
• Work effectively with other departments to resolve drawing discrepancies.
• Work with product development teams to ensure compliance when transferring documents to production releases.
• Maintain strict adherence for multiple CAD file relationships, models, assemblies, libraries, and symbols.

Must Have:

• A Bachelor's degree in STEM engineering required.
• 5 years of experience required in Tool Design
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes
• Knowledge of FDA, cGMP, GDP principles and practices, (ISO 9001, ISO 13485)
• Proficiency with Solidworks required with Pro-E/CREO experience.
• Solid working knowledge of dimensioning and Geometric tolerances, GD&T
• Blueprint reading
• Computer skills associated with Microsoft software.
• Must be able to read, write and speak fluent English.
• Excellent reading, writing, communication, and organizational skills.
• Maintains performance with changing priorities under minimal supervision.
• Possess team collaboration skills.
• Must be able to make clear and accurate decisions.
• Strong mechanical aptitude

Good to have:

• PDM file management experience preferred.
• Medical Device Experience

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.