Current Job Openings

Position Name: Controller

Classification: Full-Time/Salaried

Reports to: Director of Business Administration

Date: November 8, 2023

 

JOB DESCRIPTION

RIVANNA is seeking a seasoned Controller to contribute to the rapid growth of our emerging medical device company. You will work with a talented team of professionals as we strive to achieve our mission of improving global human health. The ideal candidate has prior successful experience managing financial systems and controls within a manufacturing and technology business that maintains multiple Federal grant and contract awards. This is a hands-on multidisciplinary role in which the right candidate will engage multiple internal and external stakeholders to develop and execute financial processes and controls. The candidate is expected to work in the company offices located in Charlottesville, Virginia.

Responsibilities

  • Oversee the accounting function and team
  • Supervise all daily, month-end, and year-end accounting procedures, journal entries, estimates, closing activities and financial reporting, (in accordance with GAAP and ensuring expense classifications in accordance with FAR Part 31), financial reporting, bank account reconciliation, grant and contract invoicing, inventory practices and cost accounting, purchasing function, credit card program, balance sheet deferrals and accruals, vendor payment processing, and accounts receivable, invoicing, and collections
  • Ensure requirements under government contracts and grants are met
  • Oversee documentation of financial policies, procedures and controls and enforce such financial controls for the business. Periodically test such controls and remediate where necessary
  • Drive financial forecasts including cash flow reports for the company
  • Oversee the budget process and monthly reporting including variances
  • With CEO and Director of Business Administration, develop key KPIs/metrics and report periodically on company performance of such metrics
  • Review and evaluate ongoing company accounting system needs and implement upgrades as needed
  • Manage relationships with bankers, auditors, tax authorities, and government officials and oversee treasury function
  • Proactively address the finance needs of the company’s department managers, including financial reporting and streamlined financial processes
  • Provide financial analysis with emphasis on capital investments, pricing decisions and contract negotiations. ‘
  • Support sales activities including commercialization of products, discounts, commissions, and product pricing
  • Formulate tax strategies to minimize taxes owed. Ensure timely filings of federal, and state returns, sales and use taxes, property and franchise taxes. Ensure compliance with tax regulations
  • Comply with federal, state, and local financial requirements by studying existing and new legislation and new accounting pronouncements while maintaining compliance with Director of Business Administration, support the CEO in his needs for the Board
  • Oversee spending trends and identify cost-savings and margin opportunities

Skills and Qualifications

  • Bachelor’s degree in accounting
  • CPA Required
  • Big 4 Experience
  • 3-5 years of operational accounting experience as the company Controller
  • Experience with accounting software and ERP systems
  • Experience with QuickBooks Enterprise and software system implementation and upgrades a plus
  • Experience in medical device companies a plus
  • Experience with government contracting and grants a plus
  • Experience in a manufacturing setting and cost accounting a plus
  • Experience managing and leading a team of professionals
  • Personal integrity; ability to keep client and company confidences
  • Proficient in Microsoft Office and PowerPoint

RIVANNA Medical offers the following employee benefits: health insurance, vision and dental, group life, long-term disability, paid time off, 401(k) with match, and more. We are always looking to complement our existing team with individuals who bring unique perspectives and experiences. This variety of thought and perspective drives innovation and strengthens our ability to create an inclusive team environment where our core values of trust, humility, and dedication are practiced every day.

RIVANNA Medical 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 accommodation may be made to enable individuals with disabilities to perform essential functions.

About the Company

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'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.

Position Name: Clinical Project Manager

Classification: Full-Time/Salaried

Reports to: Director of Program Management

Date: November 8, 2023

 

JOB DESCRIPTION

RIVANNA is seeking a talented Clinical Project Manage to contribute to the rapid growth of our emerging medical device company. You will work within a talented team of professionals as we strive to achieve our mission of improving global human health. The ideal candidate has prior successful experience in biomedical and/or clinical research management. This is a hands-on multidisciplinary role in which the right candidate will work closely with engineering, regulatory, and manufacturing programs to get our breakthrough medical technologies to direct clinical and preclinical studies.

Responsibilities

  • Overall management, integration, and coordination of all clinical program activities, including technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and direction of all clinical activities.
  • Proactively track and manage clinical development tasks against timelines and budgets.
  • Prepare clinical project status and progress reports, maintaining accurate and current details for communication to internal and potentially external stakeholders.
  • Coordinate communication and clinical project activities against program milestones and deliverables.
  • Engage with internal commercial, research and development, and manufacturing teams to ensure successful planning, coordination, and execution of clinical research work packages.
  • Responsible for development of clinical evidence generation plans and execution.
  • Perform medical and scientific review of clinical related content including scientific literature, clinical study protocols, informed consent forms, investigator brochures, case report forms, clinical study reports.
  • Participate in preparing and reviewing study documentation, competitive landscape research and feasibility studies for new proposals as required.
  • Oversee and track progress of site identification, start-up, monitoring, and study close-out activities, including managing third-party vendors and / or contract CROs.
  • Establish relationships with investigators and KOLs and maintain engagement with KOLs and stakeholders.
  • Irregular travel for conferences or to visit clinical sites is anticipated.
  • Subcontract management such as CROs and Medical Advisory Committees.
  • Develop and implement data management and quality control systems/procedures, including transmission, storage, confidentiality, and retrieval of all program data.
  • Lead clinical statistical analysis efforts and understand how to appropriately power a study for its endpoint result.

Skills and Qualifications

  • MS, PhD degree in science, or related field with clinical research experience of 5 years minimum preferred.
  • Minimum 7 years of experience in clinical research and 2 years of leading clinical research studies preferred.
  • Experience with medical device technology and clinical studies or trials.
  • Understanding of FDA medical device regulations and medical device reimbursement.
  • Excellent scientific communication skills, both verbally and written.
  • Strong scientific rigor and data analysis skills.
  • Demonstrated ability to set and meet tight deadlines and function well under pressure.
  • Strong leadership and interpersonal skills with ability to effectively engage external stakeholders and build lasting relationships

RIVANNA Medical offers the following employee benefits: health insurance, vision and dental, group life, long-term disability, paid time off, 401(k) with match, and more. We are always looking to complement our existing team with individuals who bring unique perspectives and experiences. This variety of thought and perspective drives innovation and strengthens our ability to create an inclusive team environment where our core values of trust, humility, and dedication are practiced every day.

RIVANNA Medical 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 accommodation may be made to enable individuals with disabilities to perform essential functions.

About the Company

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’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.

Position Name: Regulatory Project Manager

Classification: Full-Time/Salaried

Reports to: Director of Program Management

Date: August 31, 2023

 

JOB DESCRIPTION

RIVANNA is seeking a medical device Regulatory Project Manager to contribute to our emerging medical device company’s rapid growth. You will work with a talented team of professionals as we strive to achieve our mission to elevate global standards of care with world-first medical imaging technology. This is a hands-on multidisciplinary role in which the right candidate will actively manage and execute different aspects of RIVANNA’s pre-market regulatory activities and initiatives. The position will report directly to the Director of Program Management and involves frequent written and verbal presentations to Federal government officials. Joining RIVANNA as a Regulatory Project Manager offers an exciting opportunity to make a significant impact on our regulatory success and contribute to the growth of our organization. If you are a highly motivated and detail-oriented regulatory professional with strong project management skills, we encourage you to apply and be part of our dedicated team working towards delivering life-changing products in compliance with regulatory standards.

Responsibilities

  • Create, present, and execute premarket regulatory strategies for RIVANNA’s new breakthrough medical device products and R&D programs.
  • Coordinate and assist in preparing high-quality regulatory submissions, including premarket notifications 510(k), De Novo approval applications, and post-approval submissions.
  • Liaise with cross-functional teams, such as R&D, Quality Assurance/Regulatory Affairs, and clinical teams, to gather necessary documentation and data for submissions.
  • Coordinate with external regulatory consultants for premarket regulatory project execution and management.
  • Maintain surveillance on long-range and emerging issues related to regulation in the US and internationally.
  • Monitor, assess, and provide concise summaries of FDA regulations, guidance, and industry updates relevant to RIVANNA’s product portfolio.
  • Communicate regulatory changes and recommendations to internal stakeholders to ensure proactive compliance.
  • Organize and maintain project timelines, deliverables, and milestones related to premarket regulatory activities.
  • Track project progress, identify potential bottlenecks, and facilitate problem-solving to ensure on-time completion of regulatory milestones in coordination with other stakeholders.
  • Maintain accurate and up-to-date records of all premarket regulatory activities, ensuring that documentation is compliant with FDA requirements.
  • Generate reports and summaries for management and regulatory authorities as necessary.
  • Review and monitor regulatory compliance for clinical studies.
  • Assist clinical team with regulatory aspects of clinical study IRB submissions and approvals.
  • Responsible for all regulatory aspects of future FDA-regulated study execution.
  • Monitor, assess, and provide concise summaries of FDA-regulated medical device clinical trials, 510(k) clearances, De Novo clearances for products close to our product line for competitive analysis.

Education and Requirements

  • Advanced degree or bachelor’s degree (required) plus at least five years of regulatory affairs experience or ten years of product development experience as a major contributor to regulatory submissions.
  • Demonstrated knowledge of FDA regulations, guidance, and relevant industry standards and procedures and policies related to the conduct of clinical trials/evaluations research.
  • Proven experience in preparing FDA submissions and interacting with regulatory agencies.
  • Experience with medical devices required, software as a medical device, and/or computer-assisted detection devices preferred.
  • Demonstrated experience applying creative solutions to complex issues and problems with an open mind and can-do attitude.
  • Excellent oral and written communication skills and interpersonal skills.
  • High level of attention to detail and significant experience in project management.
  • Ability to work independently and collaboratively in a cross-functional environment.

RIVANNA Medical offers the following employee benefits: health insurance, vision and dental, group life, long-term disability, paid time off, and 401(k) with match, and more. We are always looking to complement our existing team with individuals that bring unique perspectives and experiences. This variety of thought and perspective drives innovation and strengthens our ability to create an inclusive team environment where our core values of trust, humility, and dedication are practiced every day.

RIVANNA Medical is committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, color, sex (including childbirth, breast feeding 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.

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’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.

Position Name: Senior Mechanical Engineer I

Classification: Full-Time/Salaried

Reports to: Mechanical Engineering Manager

Date: December 12, 2023

 

JOB DESCRIPTION

Rivanna Medical seeks a Senior Mechanical Engineer who will join the engineering team and contribute to the development of our ultrasound-based medical imaging products. You will work within a talented team of professionals as we strive to achieve our mission of improving global healthcare through innovative medical technology. As a Senior Mechanical Engineer, you will be responsible for specification development, design, and delivery of mechanical sub-systems for new and existing products. You will be responsible for managing mechanical part files and designing complex mechanical assemblies, while ensuring design conformance to medical-device regulatory requirements and Rivanna Medical’s internal quality management system (QMS). This position provides the opportunity to guide development through all design phases, from early prototyping to design transfer to manufacturing. Due to demanding duties, this position is required to be on-site Monday through Friday at our office located in Charlottesville, Virginia. Qualified candidates must reside within the area to commute daily to be in the office.

 

Responsibilities

  • Design, test, and integrate complex mechanical sub-systems of ultrasound-based medical imaging products
  • Define component and sub-system specifications and evaluate mechanical architectures that meet the specifications
  • Develop and oversee test plans and build test fixtures to de-risk technologies and demonstrate functionality
  • Collaborate and innovate with all stakeholders, including an interdisciplinary engineering team, management, external contractors, and the end-customer
  • Prototype mechanical designs using in-house prototyping facilities (3D printer, CNC mill, lathe, etc.)
  • Perform engineering calculations (i.e., structural analysis, tolerance analysis, etc.) and participate in design reviews
  • Independently create drawing files, produce BOMs, and identify optimal manufacturing methods (i.e., injection molding, sheet metal, mill, lathe, etc.)
  • Deliver mechanical designs on-schedule
  • Maintain conformance to Rivanna Medical’s internal quality management system

 

Education and Requirements

  • Bachelor’s degree in Mechanical Engineering or related technical discipline
  • Minimum 5 years of relevant industry work experience with Bachelor’s degree, or 3 years of relevant industry work experience with Master’s degree
  • Advanced knowledge of SolidWorks or Onshape CAD platforms
  • Understanding of adjacent technical domains and integration requirements (i.e., electrical and ultrasound)
  • Knowledge of all stages of the product development lifecycle
  • Experience in medical device design under ISO 13485 quality systems
  • Experience using an iterative design process and contributing to teams/projects with fast-paced development cycles

 

 

RIVANNA Medical offers the following employee benefits: health insurance, vision and dental, group life, long-term disability, paid time off, 401(k) with match, and more. We are always looking to complement our existing team with individuals who bring unique perspectives and experiences. This variety of thought and perspective drives innovation and strengthens our ability to create an inclusive team environment where our core values of trust, humility, and dedication are practiced every day.

 

RIVANNA Medical 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 accommodation may be made to enable individuals with disabilities to perform essential functions.

 

About the Company

 

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’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.

 

Applicants

 

Please submit your resume and interest in the position to our recruitment email address: recruiter@rivannamedical.com or apply to our website: https://rivannamedical.com/careers/

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COMPENSATION

Competitive salary
Bonus incentives
Merit-based
Process transparency

CONNECTION

Vision & values
World-class team
Collaboration
CREW*

CULTIVATION

Development
Challenge
Opportunity
Impact

CONTRIBUTION

Paid health benefits
401k match
Generous PTO
Flex time
We are always looking for exceptional talent to help us grow our diverse team. If you want to hear more about RIVANNA, email us at recruiter@rivannamedical.com.
*CREW (Creating RIVANNA Employee Wellbeing) is our employee-led advisory committee and a social engagement team committed to cultural excellence at RIVANNA.