Lead Mechanical Design Engineer for Class II and III Devices

22 hours ago


Brooklyn Park, Minnesota, United States Cirtec Medical Full time

About Us

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Cirtec Medical has been a leading outsourcing partner for complex medical devices for over three decades. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly.

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Job Description

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The Senior Mechanical Design Engineer will be responsible for defining, designing, and developing components and assemblies for Class II and Class III medical devices and related accessories. This role requires strong analytical skills to understand customer requirements, foresee technical challenges, and lead the definition of design solutions to meet customer needs.

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Main Responsibilities

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  1. Develop design requirements and specifications with mechanical and electrical components and assemblies.
  2. Create test methods and corresponding test method validations.
  3. Coordinate design verification activities.
  4. Generate 3D models and engineering drawings utilizing Solidworks.
  5. Perform tolerance analyses to ensure component interactions are understood.
  6. Communicate technical risks as they arise.
  7. Create and Check completed layouts and drawings for clarity, completeness, conformity to standards, procedures, specifications, and accuracy of calculations and dimensioning.
  8. Host design reviews with internal and external stakeholders.
  9. Serve as technical expert in phase or design reviews with internal and external stakeholders.
  10. Evaluate feasibility of concepts and provides estimates for mechanical design timelines.
  11. Manage workload to support various projects, in medium to large scale and complexity.
  12. Provides regular status updates to management and customer.
  13. Writes/updates work instructions, part specifications, verification protocols, and various technical documents.
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Requirements

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  • Bachelor's degree in an Engineering discipline.
  • Minimum of 5 years of 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.
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Benefits

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Cirtec Medical offers a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. These include training and career development opportunities, healthcare and well-being programs, paid time off, and a 401(k) retirement savings plan with a company match.

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Location

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This is not a remote position. The job is located at our headquarters in [insert location].



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