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Principal Mechanical Engineer

2 months ago

Santa Clara, California, United States Cirtec Medical Full time
About the Role

Cirtec Medical Corporation is seeking a highly skilled Principal Mechanical Engineer to join our team. As a key member of our engineering team, you will be responsible for designing, developing, and validating complex medical devices.

Key Responsibilities
  • Own the design and development of medical devices, transforming internal and external inputs into outputs
  • Develop design requirements and specifications with mechanical and electrical components and assemblies
  • Generate 3D models and engineering drawings utilizing Solidworks
  • Perform tolerance analyses to ensure component interactions are understood
  • Understand the functional performance of the products as they are developed
  • Create test methods and corresponding test method validations
  • Lead dFMEA creation
  • Coordinate design verification activities
  • Communicate technical risks as they arise
  • Perform detailed design reviews and tolerance analyses to achieve product performance, cost, reliability, and manufacturability requirements
  • Communicate directly with clients to understand needs and present results
  • Effectively interface with and manage suppliers to fabricate prototype and final components
  • Manage workload to support various projects, in larger scale and complexity
  • Mentorship of other engineers in various functions
  • Maintain compliance to procedures and regulatory requirements
  • Provide regular status updates to management and/or customer
  • Write/Update work instructions, part specifications, verification protocols, and various technical documents
Requirements
  • Bachelor's in Mechanical/Biomedical Engineering, or an equivalent engineering discipline
  • 10+ years' experience within the Medical Device industry; or a combination of education and relevant work experience
  • Experience in development of medical devices (i.e. delivery tools, catheters, consoles, surgical tools, etc.) is highly preferred
  • Experience in developing test protocols, test methods, executing engineering level tests, analyzing test data, and developing reports
  • Experience in developing test fixtures
  • Proficiency with Solidworks required
  • Excellent communication skills both written and oral
  • Experience and working knowledge of medical device design control processes highly preferred
What We Offer
  • A fast-paced work environment
  • Clean, and well-lit production areas
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives, and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a company match
Working Environment

Work is performed in an office environment. The noise level in the work environment is usually moderate.

EEO Statement

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer

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.