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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 Mechanical Design Engineer II is primarily responsible for defining, designing, and developing components and assemblies for Class II and Class III medical devices and related accessories. Able to multitask and run multiple projects while meeting customer commitments. Required are strong analytical skills to understand customer requirements, foresee technical challenges and lead the definition of design solutions to meet customer needs. The Mechanical Design Engineer II leads the design efforts for small to medium scale programs, can work independently, and act as a technical lead. Key Responsibilities: Lead the mechanical development of new designs, improve existing designs, and transition current and future designs into production. Own the design and development of medical devices through: Transformation of internal and external inputs into outputs Develop design requirements and specifications with mechanical and electrical components and assemblies. Create test methods and corresponding test method validations. Coordinate design verification activities. Generate 3D models and engineering drawings utilizing Solidworks. Perform tolerance analyses to ensure component interactions are understood. Communicate technical risks as they arise. Create and Check completed layouts and drawings for clarity, completeness, conformity to standards, procedures, specifications, and accuracy of calculations and dimensioning. Host design reviews with internal and external stakeholders. Evaluate feasibility of concepts and provides estimates for mechanical design timelines. Manage workload to support various projects, in smaller scale and complexity. Provides regular status updates to management and customer. Maintain compliance to procedures and regulatory requirements. Writes/updates work instructions, part specifications, verification protocols, and various technical documents. This is not a remote position. Must Have: Bachelor's degree in a STEM engineering discipline At least 2 years of experience FDA, cGMP, GDP principles and practices, (ISO 9001, ISO 13485) Proficiency with CAD Understands tolerance stack ups, DFM, and GD&T for proper design alignment in assemblies. Experience in an engineering environment with mechanical, tool design, and manufacturing processes Able to multitask and support multiple projects while meeting customer commitments. Maintain performance with changing priorities under supervision. Must be able to read, write and speak fluent English Excellent reading, writing, communication, and organizational skills. Good to have: Solidworks experience Medical Device Experience Competitive market salary from $80000 to 92000 per year depending on qualifications and 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 ulture 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. 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.