Sr. Mechanical Design Engineer

Cirtec • Brooklyn Park, MN

283d • $105,000 - $125,000 • Onsite

About The Position

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! The Senior Mechanical Design Engineer 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 Senior Mechanical Design Engineer leads the design efforts for medium to large scale programs, can work independently, act as a technical lead, and be a mentor to other engineers.

Requirements

• Bachelor's degree in an Engineering (STEM) discipline.
• Minimum of 5+ years of work experience.
• Experience and knowledge of working under quality management systems that meet governmental regulations such as FDA QSR, ISO 13485, the MDD relevant standards, and have knowledge cGMP, GDP principles and practices.
• Experience implementing Design for Manufacturability (DFM) principles into design.
• Proficiency with CAD - SolidWorks preferred.
• Understands tolerance stack ups, DFM, and GD&T for proper design alignment in assemblies.
• Good understanding of the product development process within the medical device industry.
• Able to multitask and support multiple projects while meeting customer commitments.
• Excellent reading, writing, communication, and organizational skills.

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.
• Serve as technical expert in phase or 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 medium to large scale and complexity.
• Provides regular status updates to management and customer.
• Writes/updates work instructions, part specifications, verification protocols, and various technical documents.

Benefits

• Training and career development.
• Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs.
• Paid Time Off.
• 401(k) retirement savings with a company match.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Publishing Industries
• Education Level: Bachelor's degree