Veran^® Careers

We’re looking for a Clinical Support Specialist to assist in the oversight and support of the remote operation of Veran’s SPiN Thoracic Navigation System^® and related products. The Clinical Support Specialist will be responsible for educating, training, and supporting physicians and hospital personnel on all aspects of Veran’s System, products, and services, with special emphasis on Veran’s remote platforms.

Location: St. Louis, MO
Listing Date: October 10, 2019
Position: Clinical Support Specialist
Job Type: Full-Time
Education: Bachelor's Degree
Direct Report: Medical Education and Customer Support Manager

Responsibilities:

• Participate in the utilization and improvement of a new cutting edge remote procedure support system.
• On site and remotely operate Electromagnetic Navigation Systems to educate and train physicians and all hospital personnel on all aspects of our products and services
• Provide remote guidance and assistance to physicians and medical staff by evaluating options and problem solving during clinical procedures
• Direct and assist all hospital entities in performing necessary pre-procedural duties
• Effectively log support calls using all necessary metrics
• Respond to support emails efficiently
• Appropriately organize, analyze and communicate data
• Contribute to the quality improvement process by recommending product modifications
• Provide ongoing technical support for existing accounts
• Maintain proper knowledge base regarding developments, products and services via ongoing training and independent research in the required medical fields
• Perform other duties and responsibilities needed to meet the needs of the organization
• Assist as needed with field service requests, including but not limited to procedure support, installations, evaluations, and training

Qualifications:

• Bachelor’s Degree in related field preferred.
• Computed Tomography experience is desired
• 2-3 years of experience within the healthcare arena preferred
• Proficient in the use of PC software applications, including Microsoft Office
• Must be willing to travel 20%-30%
• Self-motivated, detail-oriented
• Problem-Solving Skills
• Prior experience with Image Guided Surgery desired

Veran Medical Technologies, Inc. is a rapidly growing venture backed, private health care company focused on saving lives by enabling faster diagnosis of lung cancer. We have a fantastic mission, great team, and a disruptive, industry leading technology.

We’re looking for an Associate Product Manager to lead the commercialization of key products and services for our SPiN Thoracic Navigation SystemTM. The SPiN SystemTM is an FDA cleared, next generation electromagnetic thoracic navigational platform that assists physicians in the early diagnosis and treatment of lung cancer. The Associate Product Manager will be responsible for all aspects of the product lifecycle, from concept to commercialization, including product launch and post-market surveillance.

Location: St. Louis, MO
Listing Date: May 26, 2020
Position: Associate Product Manager – Software Applications
Job Type: Full-Time
Education: Bachelor's Degree
Direct Report: Senior Upstream Product Manager

Responsibilities:

• Manage software applications: SPiN Planning™, SPiN Drive®, SPiN IR™, vSupport™ Connect, and other software applications
• Execute programmatic sales initiatives to drive adoption and utilization while reporting weekly to track success
• Develop, monitor, and report on key product performance metrics, and interpret data in order to make data-driven recommendations for changes to strategy and programs
• Act as the internal product leader – representing customer and interests of the business when dealing with key internal stakeholders such as engineering, operations, quality, regulatory, finance, and sales
• Serve as a critical resource for the field sales team in interpreting clinical data, guidelines, product benefits, and competitive positioning
• Develop a marketing plan that includes key positioning and messaging, and is constantly refined based on new relevant clinical data
• Establish relationships with key customers to develop advocates and educate influential leaders on product performance
• Oversee product lifecycle process, drive product level changes and communicate those changes to internal teams and customers
• Assist in development of positioning and messaging in support of product strategy and launch
• Work intimately with customers and field sales to understand potential product enhancements and modifications
• Work intimately with vSupport to analyze and organize customer feedback
• Lead the monitoring and communication of competitive activity, market trends, and strategic responses
• Wear multiple hats, and complete other tasks as assigned based on top company priorities

Qualifications:

• A minimum of a Bachelor’s degree is required (MBA preferred)
• 3-5 years medical device marketing experience is preferred
• A minimum of 2 years of experience demonstrating and utilizing Project Management and Product Lifecycle Management practices
• Experience demonstrating and utilizing Project Management and Product Lifecycle Management practices preferred
• Excellent oral and written communication skills
• Ability to work independently and influence without formal authority
• Experience working in a start-up environment or small company
• Ability to partner and engage with a cross-section of people at multiple levels of the organization
• Experience and ability to manage multiple projects with competing priorities to meet project deadlines
• Strong customer relationship skills and prior experience in a customer-facing role
• This position requires 20-40% domestic travel

We’re looking for a Regulatory Engineer – Level II to assist in timely completion of all worldwide regulatory activities relating to product compliance, marketing clearance and certification of FDA Class II medical devices. Prepare and/or facilitate 510(k) submissions, Letters to File, Technical Files, CB Reports and technical construction files. Support compliance of all existing and new products to domestic and international regulations and standards including, but not limited to EU MDR, IEC and ANSI/AAMI. Support compliance of the Quality System to the requirements of FDA’s Quality System Regulation, ISO 13485, ISO 14971 and related standards. Support proper implementation and use of established QA/RA policies and processes

Location: St. Louis, MO
Listing Date: October 10, 2019
Position: Regulatory Engineer – Level II
Job Type: Full-Time
Education: Bachelor’s degree preferred OR demonstrated equivalent experience
Direct Report: Director of Quality Assurance and Regulatory Affairs

Responsibilities:

• Coordinate product marketing clearance and certification activities with respect to planning, scheduling and submitting regulatory documents (e.g. – 510(k)s, letters to file, product licenses) based upon a thorough knowledge of FDA regulations, guidance documents and international licensing requirements
• Represent regulatory affairs and assure proactive relationship in various cross-functional meetings and project teams with engineering, operations, marketing, quality and clinical affairs to ensure that all products are and remain in compliance
• Review and approve product and process change orders to ensure regulatory and standards compliance
• Review and approve product labeling to ensure accuracy in supportability of claims and to ensure fulfillment of product labeling requirements
• Prepare regulatory filings as appropriate
• Prepare and submit adverse events as appropriate to affected regulatory bodies
• Perform risk management activities per ISO 14971 and participate in product risk analysis activities
• Perform internal regulatory audits to verify compliance of products with applicable safety standards and technical construction reports
• Participate in product design reviews to identify potential design issues and to assist project teams with design solutions
• Other tasks as assigned

Qualifications:

• Bachelor’s degree preferred OR demonstrated equivalent experience
• 5 to 8 years of relevant medical device industry experience, preferred in Regulatory Engineering
• RAPS Regulatory Affairs Certification preferred, but not mandatory
• Knowledge of ISO 13485:2016, FDA Quality System Regulation, MDR knowledge preferred
• Good record-keeping and attention to detail
• Proficient in product & process development concepts, including change control, design verification and validation and risk management
• Problem solving abilities for medical device and process improvements
• Excellent written and verbal communication skills, including ability to communicate technical information
• Good recordkeeping and attention to detail
• Experience in medical device submissions for 510(k), CE certification, etc. preferred
• Ability to read, write and speak English
• Proficient in product & process development concepts, including change control, design verification and validation and risk management
• Organizational skills, detail oriented, trustworthy

We’re looking for a Quality Engineer Hardware – Level II to assist in providing Quality Engineering support for quality systems, medical devices related to hardware (systems and instrumentation) and manufacturing processes. Provides support, leadership and participation related to quality engineering to teams directed at developing, maintaining and improving medical devices related to hardware and manufacturing processes. Analyzes data on medical devices related to hardware and manufacturing processes to determine opportunities for improvement.

Location: St. Louis, MO
Listing Date: May 18, 2020
Position: Quality Engineer Hardware – Level II
Job Type: Full-Time
Education: Bachelor’s degree preferred OR demonstrated equivalent experience
Direct Report: Quality Systems Manager

Responsibilities:

• Provides quality oversight/guidance for company medical devices, related to hardware (systems and instrumentation) and quality systems
• Ability to combine input from multiple sources to provide solutions to organization regarding product quality, design and regulatory compliance
• Reviews and approves work for inclusion in Medical Device Reports (MDRs) and provides support in the investigations of MDRs
• Participates in complaint activities and corrective and preventive action (CAPA) related activities
• Communicates significant issues or developments identified during quality assurance activities and provides recommended improvements
• Provides Quality Engineering guidance to product development teams throughout the product development process to ensure compliance to the required deliverables, resulting in the development of safe and effective medical devices to include verification and validation activity
• Analyzes data from various sources including but not limited to nonconformances, complaints, etc. to drive decision-making and effective corrective and preventative actions
• Key participant in change management and provides guidance for new product development and existing products and processes
• Recommends, leads and/or supports projects for improvements to the Quality System

Qualifications:

• Bachelor’s degree preferred OR demonstrated equivalent experience
• 3 to 5 years of relevant medical device industry experience, preferred in Quality Engineering
• Certification as an ASQ Quality Engineer preferred, but not mandatory
• Working knowledge of Quality concepts, regulatory compliance requirements and tools including ISO 13485:2016, FDA Quality System Regulation, EU MDR, etc. preferred
• Applies organizational and technical knowledge to move teams through issues
• Proficient in product & process development concepts, including change control, design verification and validation and risk management
• Problem solving abilities for medical device and process improvements
• Excellent written and verbal communication skills, including ability to communicate technical information
• Good recordkeeping and attention to detail
• Ability to read, write and speak English
• Organizational skills, detail oriented, trustworthy