Mechanical Engineer: IVF Device Design Specialist

3 weeks ago

Reston, Virginia, United States Overture Life Full time

Position: Mechanical Engineer specializing in IVF Medical Devices

Location: Palo Alto

Reports to: VP of Engineering

FLSA Status: Exempt/Salary

Overture Life is a leader in automating the embryology lab to standardize and improve IVF processes.

We are addressing the high costs and low success rates in IVF by developing innovative medical devices.

The DaVitri device uses microfluidics to automate egg freezing, and our other products span robotics, mass spectrometry, machine vision, and machine learning.

Job Summary:

As a Mechanical Engineer specializing in IVF medical devices, you will play a crucial role in designing and developing advanced reproductive technologies.

This position offers a unique opportunity to lead the design and innovation of cutting-edge IVF medical devices, shaping the future of reproductive health.

Key Responsibilities:

  • Design and Development:
  • Lead the design and development of mechanical components and systems for IVF medical devices.
  • Create detailed CAD models and engineering drawings, ensuring accuracy and compliance with industry standards.
  • Conduct design analysis, including stress, thermal, and fluid dynamics simulations, to validate performance and reliability.
  • Prototyping and Testing:
  • Oversee the fabrication of prototypes and conduct hands-on testing to evaluate functionality, durability, and safety.
  • Analyze test data and refine designs based on results to improve device performance and user experience.
  • Cross-Functional Collaboration:
  • Work closely with electrical engineers, software developers, and clinical experts to integrate mechanical designs with other engineering disciplines.
  • Collaborate with regulatory affairs and quality assurance teams to ensure compliance with FDA regulations and ISO standards.
  • Documentation and Reporting:
  • Prepare and maintain comprehensive design documentation, including design reports, test plans, and validation protocols.
  • Provide regular updates on project progress and technical challenges to project stakeholders.
  • Innovation and Improvement:
  • Stay current with advancements in mechanical engineering and medical device technology, particularly in the IVF field.
  • Propose and implement innovative solutions to enhance device functionality, reliability, and ease of use.

Required Qualifications:

  • Education: Bachelor's degree in Mechanical Engineering or a related field.
  • Experience: Minimum of 3 years of experience in mechanical design, with a focus on medical devices or complex systems.
  • Skills:
  • Proficiency in CAD software (e.g., Onshape, SolidWorks) and engineering analysis tools.
  • Strong understanding of mechanical design principles, materials, and manufacturing processes.
  • Experience with prototyping and hands-on testing of mechanical components.
  • Knowledge of regulatory requirements for medical devices (e.g., FDA, ISO 13485).
  • Excellent problem-solving skills and attention to detail.
  • Strong communication skills and ability to work effectively in a team environment.

Preferred Qualifications:

  • Advanced degree in Mechanical Engineering or a related field.
  • 5+ years of experience in the medical device industry, specifically with IVF technologies or similar medical devices.
  • Experience with design for manufacturability and design for assembly principles.
  • Familiarity with additive manufacturing techniques and rapid prototyping.
  • Knowledge of human factors engineering and usability testing for medical devices.
  • Experience with software integration and interdisciplinary project coordination.
  • Professional certifications related to mechanical engineering or medical device design.

Additional Information:

  • Work Environment: Office-based, our office is in Palo Alto
  • Travel Requirements: Some flexibility to travel domestically and internationally, up to 6 weeks a year for clinical instrument testing

Benefits:

Industry competitive pay, stock options in a fast-growing technology company, health insurance package options, paid parental leave, 401(k), and paid time off.

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