Sr. Mechanical Designer

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 Sr. Mechanical Designer position is primarily responsible for developing and designing medical devices, tooling and fixtures from concepts and sketches utilizing SolidWorks 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 utilizing SolidWorks Concept design Design detailed tooling, gage, and fixture engineering drawings independently and with input from the subject matter expert or engineer Design detailed medical device related engineering drawings independently and with input from the subject matter expert or engineer Review engineering drawings to ensure adherence to specifications and standards Design reviews Manage workload to support various departments 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 Maintain compliance to procedures and regulatory requirements Maintain CAD database support in multiuser environment Support PDM Vault Review ECN's for drawing release and revisions Reliable, consistent, and punctual attendance is an essential function of the job Complies with company, quality, and safety standards, policies and procedures Must Have: Associates degree in an Engineering discipline or related field 7 plus years' experience in the engineering/manufacturing environment (Machining, Finishing, and assembly) for medical devices related to product and tool design FDA, cGMP, GDP principles and practices (ISO 9001, ISO 13485) Proficiency with Solidworks and Solidworks PDM Vault required 3D Printing knowledge Understanding of toolmaking/machining practices Ability to use basic hand and power tools Solid working knowledge of dimensioning and Geometric tolerances, GD&T Computer skills associated with Microsoft software Must be able to read, write and speak fluent English Excellent reading, writing, communication, and organizational skills 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. 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 pr vides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.