Principal Mechanical Engineer

2 days ago

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

Rivanna Medical, Inc. is seeking an experienced Principal Mechanical Engineer to lead our dynamic engineering team in the development of world-first imaging-based medical technologies.

As a Principal Mechanical Engineer, you will be responsible for leading mechanical engineering development of multiple projects at all stages from concept to commercialization. You will work closely with cross-functional teams to translate user needs into system requirements and mechanical specifications.

The ideal candidate has a strong background in mechanical design and product development, with a proven track record of leading complex mechanical design projects in a cross-functional, fast-paced environment and delivering products to market in the medical device industry.

Key Responsibilities
  • Lead Mechanical Development: Architect, design, develop, and validate mechanical systems for ultrasound-based medical devices and single-use consumables
  • Technical Leadership: Provide technical oversight and guide mechanical design teams on multiple projects simultaneously, at all stages from concept through production
  • Innovation: Drive continuous improvement and innovation in mechanical design technologies, materials, and processes to improve product performance and reliability while reducing costs
  • Collaboration: Work closely with cross-functional teams to translate user needs into system requirements and mechanical specifications
  • Verification: Develop test protocols and manufacturing fixtures for mechanical components and systems. Oversee prototype testing, performance evaluation, and documentation to ensure compliance with design specifications and regulatory standards
  • Manufacturing Support: Work closely with suppliers, internal manufacturing team, and external manufacturing partners to ensure successful design transfer to production, maintain the device history file, and execute engineering change orders
  • Team Development: Mentor and develop junior engineers, providing technical guidance and fostering a culture of continuous improvement within the mechanical engineering team
  • Compliance: Ensure mechanical designs and development processes meet QMS and regulatory requirements, including ISO 13485, FDA regulations (21 CFR 820), and IEC Requirements
Requirements
  • Minimum of Bachelor's degree in Mechanical Engineering or a related field, with advanced degree preferred
  • 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
  • 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.)
  • Expertise in designing for manufacturability and assembly (DFM/DFA) and specifying/scaling-up manufacturing processes for low-, mid-, and high-volume production
  • Experience designing both complex electromechanical medical devices and single-use consumables while successfully incorporating industrial design, human factors, sterilization, and packaging inputs
  • 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)
  • Excellent verbal and written communication skills, with the ability to present complex technical information clearly and concisely to RIVANNA leadership and external stakeholders
  • Strong problem-solving and decision-making abilities, with a track record of analyzing complex issues and implementing effective solutions
  • Demonstrated leadership abilities with experience in mentoring and developing engineering talent
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. Rivanna Medical, Inc. operates an FDA-registered and ISO 13485:2016 certified manufacturing facility where it produces the Accuro product line and related medical equipment and components.

Accuro is the world's first spinal navigation device designed to improve the safety, speed, and efficiency of spinal needle guidance procedures.

Rivanna Medical, Inc.'s revolutionary platforms feature BoneEnhance Multi-Frequency Image Reconstruction, which optimizes ultrasound for the visualization of bony versus soft tissue anatomy, and SpineNav3DTM AI-Based Spine Recognition, which automates ultrasound image interpretation.

Employee Benefits

Rivanna Medical, Inc. offers a comprehensive benefits package, which includes 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 continually seeking to enhance our team with individuals who bring unique perspectives and experiences. This diversity of thought and perspective drives innovation and strengthens our commitment 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.

All employees must be able to lift at least 25 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of their positions.

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