Principal Mechanical Engineer

2 days ago

Charlottesville, Virginia, United States Rivanna Medical Full time
About the Role

Rivanna Medical, Inc. is seeking a highly experienced Principal Mechanical Engineer to lead the development of our cutting-edge medical imaging solutions. As a key member of our engineering team, you will be responsible for designing, developing, and validating mechanical systems for our ultrasound-based medical devices and single-use consumables.

Key Responsibilities
  • Technical Leadership: Provide technical oversight and guidance to mechanical design teams on multiple projects simultaneously, from concept through production.
  • Design and Development: Architect, design, develop, and validate mechanical systems for medical devices and consumables, ensuring compliance with design specifications and regulatory standards.
  • Collaboration: Work closely with cross-functional teams, including product management, clinical, manufacturing, and other engineering disciplines, to translate user needs into system requirements and mechanical specifications.
  • Testing and Verification: Develop test protocols and manufacturing fixtures for mechanical components and systems, overseeing prototype testing, performance evaluation, and documentation.
  • Manufacturing Support: Collaborate with suppliers, internal manufacturing teams, and external manufacturing partners to ensure successful design transfer to production and maintain the device history file.
  • Team Development: Mentor and develop junior engineers, providing technical guidance and fostering a culture of continuous improvement within the mechanical engineering team.
Requirements
  • Education: Minimum of Bachelor's degree in Mechanical Engineering or a related field, with advanced degree preferred.
  • Experience: Minimum of 10 years of related experience in mechanical design engineering, with at least 5 years in a leadership role in medical device product development preferred.
  • Skills: Expertise in 3D CAD software (SolidWorks or Onshape preferred) and proficiency in relevant mechanical engineering design tools and methodologies (GD&T, tolerance analysis, FEA, etc.).
  • Design and Manufacturing: Expertise in designing for manufacturability and assembly (DFM/DFA) and specifying/scaling-up manufacturing processes for low-, mid-, and high-volume production.
  • Medical Device Regulations: Strong knowledge of medical device regulations, standards, and quality management systems, including ISO 13485, FDA design controls, IEC 60601, and risk management processes (ISO 14971).
  • Communication and Leadership: Excellent verbal and written communication skills, with the ability to present complex technical information clearly and concisely to RIVANNA leadership and external stakeholders.
About Rivanna Medical, Inc.

Rivanna Medical, Inc. is a privately held designer, manufacturer, and distributor of world-first, imaging-based medical solutions based in Charlottesville, VA. Our company operates an FDA-registered and ISO 13485:2016 certified manufacturing facility where we produce the Accuro product line and related medical equipment and components.

Employee Benefits

Rivanna Medical, Inc. offers a comprehensive benefits package, including health insurance, vision and dental coverage, group life insurance, long-term disability insurance, paid time off, a 401(k) plan with company match, and more. We are committed to creating an inclusive team environment where our core values of trust, humility, and dedication are practiced every day.

Equal Employment Opportunity Statement

Rivanna Medical, Inc. is committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, color, sex (including childbirth, breastfeeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age, protected medical condition, genetic information, disability, or any other protected status in accordance with all applicable federal, state, and local laws.

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