Rivanna Medical, Inc. is seeking an experienced Staff Mechanical Engineer to join our dynamic engineering team. You will work with a talented team of professionals as we strive to achieve our mission to develop and commercialize world-first imaging-based medical technologies that elevate global standards of care. In this role, you will lead the mechanical engineering development of multiple projects at stages ranging from concept to production. 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. This job will be on-site in Charlottesville, VA; applicants must be willing to relocate to Charlottesville, VA for this position.

Responsibilities:

• Mechanical Development: Lead the architecture, design, development, and validation of 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, ensuring all designs meet performance, manufacturability, and regulatory requirements.
• Cross-Functional Collaboration: Work closely with cross-functional teams, including product management, clinical, and manufacturing, to translate user needs into system requirements and mechanical specifications. Collaborate with electrical, software, and ultrasound engineering disciplines to ensure seamless system integration.
• Testing & Verification: Develop and oversee test protocols, verification testing, and documentation for mechanical components and systems 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.
• Continuous Improvement: Drive innovation through the introduction of new technologies, materials, and processes to improve product performance and reliability while reducing costs.
• Team Mentorship: Provide technical guidance and mentorship to junior engineers, fostering a culture of continuous improvement and professional development within the mechanical engineering team.
• Compliance: Ensure mechanical designs meet QMS and regulatory requirements, including ISO 13485, FDA regulations (21 CFR 820), and IEC 60601.

• Bachelor’s degree in Mechanical Engineering or a related field is required, with an advanced degree preferred.
• 10 + years of related experience in mechanical design engineering is required, with at least 3 + 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 including 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.
• Experience with industrial design, human factors, sterilization, and packaging considerations.
• Understanding of medical device regulations, standards, and quality management systems including ISO 13485, FDA design controls, IEC 60601, and ISO 14971.
• Excellent verbal and written communication skills, with the ability to present complex technical information clearly and concisely to team members, Rivanna Medical, Inc. leadership, and external stakeholders.
• Strong problem-solving and decision-making abilities, with a track record of delivering innovative solutions to complex challenges.
• Demonstrated leadership abilities with experience in mentoring and developing engineering talent.   

About Rivanna Medical, Inc.: RIVANNA® is a privately held designer, manufacturer, and distributor of world-first, imaging-based medical solutions based in Charlottesville, VA. RIVANNA 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 SpineNav3D™ AI-Based Spine Recognition, which automates ultrasound image interpretation.

Employee Benefits at Rivanna Medical, Inc.: 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.