Description:
RIVANNA is seeking a Senior 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 design, test, and integrate mechanical subsystems for new and existing products. The ideal candidate has a strong background in mechanical design and product development, with a proven ability to lead complex mechanical projects in a fast-paced, cross-functional environment and bring medical devices to market. This job will be on-site in Charlottesville, VA; applicants must be local or willing to relocate to Charlottesville for this position.

EMPLOYEE BENEFITS AT RIVANNA MEDICAL:

Rivanna Medical 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.

Requirements:

• Minimum of Bachelor’s degree in Mechanical Engineering or a related field, with advanced degree preferred.
• Minimum of 7 years of related experience in mechanical design engineering, with at least 2 years in a technical leadership role in electromechanical product development preferred.
• Advanced knowledge of 3D CAD software (SolidWorks preferred) and proficiency in relevant mechanical engineering design tools and methodologies (structural analysis, FEA, tolerance analysis, GD&T, etc.).
• Strong knowledge in designing for manufacturability and assembly (DFM/DFA) and specifying manufacturing processes for low-, mid-, and high-volume production.
• Experience with full-lifecycle development of electromechanical products and high-volume consumables while successfully incorporating industrial design, human factors, sterilization, and packaging inputs.
• Experience applying an iterative design process within collaborative teams and fast-paced development cycles.
• Familiarity with adjacent technical domains (e.g., electrical, software, and ultrasound) and system integration process.
• Basic knowledge of medical device regulations, standards, and quality management systems including ISO 13485, FDA design controls, IEC 60601, and risk management processes (ISO 14971).
• Strong 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

• Product Development: Design, develop, and validate mechanical subsystems for ultrasound-based medical devices and single-use consumables at all stages from concept through production.
• Mechanical Design: Independently design mechanical assemblies, create drawing files, produce BOMs, and identify optimal manufacturing methods. Use mechanical engineering design tools & methodologies (DFM/DFA, structural analysis, FEA, tolerance analysis, GD&T, etc.) to deliver products which meet specifications.
• Testing & Verification: Develop test protocols and design test fixtures for mechanical components and systems. Oversee prototype testing, performance evaluation, and documentation to ensure compliance with design specifications and regulatory standards.
• Technical Leadership: Provide technical oversight to small mechanical design teams throughout the development cycle. Communicate mechanical development status, needs, and risks to cross-functional project teams.
• Collaboration: Collaborate with other engineering disciplines (electrical, software, and ultrasound) to translate system requirements into mechanical specifications and perform system integration.
• Manufacturing Support: Work closely with suppliers, internal manufacturing team, and external manufacturing partners to design manufacturing fixtures, perform design transfer to production, maintain the device history file, and execute engineering change orders.
• Compliance: Ensure mechanical designs and development processes meet QMS and regulatory requirements, including ISO 13485, FDA regulations (21 CFR 820), and IEC 60601.

Requirements:

• Minimum of Bachelor’s degree in Mechanical Engineering or a related field, with advanced degree preferred.
• Minimum of 7 years of related experience in mechanical design engineering, with at least 2 years in a technical leadership role in electromechanical product development preferred.
• Advanced knowledge of 3D CAD software (SolidWorks preferred) and proficiency in relevant mechanical engineering design tools and methodologies (structural analysis, FEA, tolerance analysis, GD&T, etc.).
• Strong knowledge in designing for manufacturability and assembly (DFM/DFA) and specifying manufacturing processes for low-, mid-, and high-volume production.
• Experience with full-lifecycle development of electromechanical products and high-volume consumables while successfully incorporating industrial design, human factors, sterilization, and packaging inputs.
• Experience applying an iterative design process within collaborative teams and fast-paced development cycles.
• Familiarity with adjacent technical domains (e.g., electrical, software, and ultrasound) and system integration process.
• Basic knowledge of medical device regulations, standards, and quality management systems including ISO 13485, FDA design controls, IEC 60601, and risk management processes (ISO 14971).
• Strong 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.