Design Engineering Expert for Complex Medical Equipment

17 hours ago

Brooklyn Park, Minnesota, United States Cirtec Medical Full time

About Us

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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.

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Job Description

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We are seeking a highly skilled Senior Mechanical Design Engineer to join our team. As a key member of our design team, you will be responsible for leading the design efforts for medium to large scale programs. You will have a strong analytical mindset, excellent communication skills, and the ability to multitask while meeting customer commitments.

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Main Responsibilities

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  • Define, design, and develop components and assemblies for Class II and III medical devices and related accessories.
  • 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.
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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 competitive salary, ranging from $120,000 to $150,000 per year, depending on experience. We also offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

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