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Veran® Careers

Veran Medical Technologies® is a rapidly growing, venture-backed private healthcare company with a disruptive, industry-leading technology. We’re on a mission to transform the standard of care for early cancer diagnoses and treatment. If you’re passionate about making a meaningful difference in the healthcare industry, this is the place for you. As a dynamic start-up, each team member is integral to our success. We’re looking for self-motivated individuals who like autonomy and love a challenge.

Current Positions

PURPOSE/SUMMARY

Members of our engineering team are responsible for designing innovative medical devices, products and tools to support the Company’s current product lines, as well as new products in the development pipeline. Our software engineers focus on developing algorithms and user interfaces to cover a wide range of clinical applications such as Image Guided Surgery, Ultrasound, and Artificial Intelligence.  Senior Software Engineers may take on project lead responsibilities and be called upon to solve challenging algorithmic problems with little supervision.  Additionally, final tier support for reported field issues /complaints may be required.

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Location: Golden, CO
Listing Date: February 11, 2021
Position: Senior Software Engineer
Job Type: Full-Time
Education: BS degree in Electrical Engineering, Computer Science, Applied Mathematics or related field required. Graduate degree in related field preferred.
Direct Report: Vice President, Application Development

PRIMARY DUTIES AND RESPONSIBILITIES

  • Participate in the development and release of new software products to assist physicians with detection and diagnosis of lung cancer
  • Contribute to the creation, design and improvement of Image Guided Surgery, Ultrasound, and Artificial Intelligence software algorithms and end-user applications
  • Project lead responsibilities, including:
    • Development of new projects according to established design control and quality procedures
    • Oversight of on-going feature and maintenance software releases
    • Acting as final tier software support for all reported issues
  • Create, maintain and implement source code that comprises the application or program for Company software
  • Design and implement unit test suites and/or automated UI testing
  • Participate in design reviews and application architecture
  • Establish and thoroughly document software specifications and V&V protocols for sub-systems or components
  • Adhere to development timelines
  • Resolve design problems with urgency, creativity and collaboration

MINIMUM QUALIFICATIONS

Experience*:

  • Programming experience in C/C++ required
  • 5+ years of professional software development experience required
  • Previous experience working in a medical device company or life science field preferred

 Skills & Competencies:

  • Experience in one or more of the following fields preferred
    • 2D/3D imaging and algorithm development (segmentation, volume rendering, linear algebra, etc.)
    • Ultrasound medical imaging and algorithm development (e.g. RF acquisition and filtering, beamforming, synthetic aperture concepts, display processing, etc)
    • AI networks, training, user interfaces
  • Experience with one or more of the following tools preferred
    • OpenGL Shaders
    • NVIDIA CUDA
    • Qt – for application and GUI development
    • MATLAB
  • Hard working, intelligent, technical acumen, self-motivated, ability to multitask
  • Operate with little or no supervision
  • Effective decision making
  • Proven ability to design components and/or sub-systems
  • Strong problem-solving skills
  • Strong communication skills

Other Considerations (travel/hours availability, etc.):

  • Travel to other Company facilities, hospitals, and animal lab settings may be required
  • Other projects and duties as necessary and assigned.
  • Ability to work overtime is required

PHYSICAL DEMANDS

  • Stand/Sit/Walk 8 hrs a day
  • Dexterity required

PURPOSE/SUMMARY

Members of our engineering team are responsible for designing innovative medical devices, products and tools to support the Company’s current product lines, as well as new products in the development pipeline. The Project Manager manages approved projects that are complex in nature from conception through completion to include scope time and cost. Overall accountability for the implementation for each assigned project. They are held accountable for adhering to company project methodology standards and processes. They must fully understand medical device design control requirements and be able to work effectively in a cross functional team.

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Location: Saint Louis, MO
Listing Date: February 11, 2021
Position: Engineering Project Manager
Job Type: Full-Time
Education: BS in Biomedical or Mechanical Engineering, or Engineering Management
Direct Report: Director of Hardware Engineering

PRIMARY DUTIES AND RESPONSIBILITIES

  • Develops and implements project plan, including cost, schedule, risk and performance for projects/programs.
  • Sets and drives objectives to completion.
  • Actively uses project schedules and other tools to manage scenario analysis in order to provide the teams options and provide visibility to risks ahead of time to enable in process change management with the internal and external stakeholders.
  • Responsible for team and cross-functional level communications.
  • Participates in project design and phase reviews; defines and tracks key business unit and project metrics; Responsible for elevating critical business risks on projects to the business and/or functional managers.
  • Influences and drives cross-functional collaboration.
  • Develops understanding of the business and technology to help drive success in the change management activities throughout the PLCP process.
  • Identifies, communicates, and manages project risk.
  • Overcomes obstacles and drives collaboration to meet goals.
  • PDP (product development process) system knowledge through delivery of project deliverables.
  • Knowledge of quality system use for the creation and continued compliance of products.
  • Financial management – budget, forecast, and strategic plan input and preparation.

MINIMUM QUALIFICATIONS

Experience*:

  • 5+ years of work experience primarily in medical device or related field

Skills & Competencies:

  • Demonstrated technical or project management experience with engineering systems (capital/hardware)
  • Project Management Certification (PMP) or related experience desired.
  • Must possess strong knowledge in the use of project management methodologies and tools such as MS Project
  • Proven ability to manage multiple projects involving numerous internal and external stakeholders.
  • Class II or Class III Medical Device product development experience
  • IEC 60601 EMC and Safety Testing experience preferred
  • Problem solving technical expertise.
  • Works under minimal supervision.
  • Strong problem-solving skills
  • Strong communication skills

Other Considerations (travel/hours availability, etc.):

  • Travel to other Company facilities, vendors, hospitals, and animal lab settings may be required
  • Other projects and duties as necessary and assigned.
  • Ability to work overtime is required

PHYSICAL DEMANDS

  • Stand/Sit/Walk 8 hrs a day
  • Dexterity required

 

PURPOSE/SUMMARY

The Quality Engineer supports the development and manufacturing of Olympus products during all phases of design, development, production, and distribution. The Quality Engineer is responsible for:

  • Acting as the Quality Representative on Product Development project teams
  • Generating and maintaining the product Risk Management file
  • Reviewing QMS and Design Changes
  • Defining Inspection and test methods and systems
  • Managing Non-Conforming reports
  • Handling Complaints and product investigations of device returns
  • Corrective and preventive action
  • Maintenance of Quality Management System by ensuring compliance to U.S. and international regulatory requirements for medical devices and harmonization with corporate requirements
  • Hosting Internal and external quality audits and identifying/addressing corrective action plans.
  • Preparing and maintaining Quality Metrics

Support continuous improvement opportunities

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Location: St. Louis, MO
Listing Date: March 15, 2021
Position: Quality Engineer II
Job Type: Full-Time
Education: BS degree or equivalent in an engineering or life science discipline is required
Direct Report: Quality Systems Manager

PRIMARY DUTIES AND RESPONSIBILITIES 

  • Support design and development projects
    • Represent the Quality team. Provide input and coordinate activities related to:
      • Risk analysis activities (design and process FMEAs).
      • Oversight of verification and validation activities.
      • Acceptance criteria and inspection methods of components and assemblies.
      • Product labeling and specifications.
    • Review Design History File.
    • Provide project team with guidance on compliance to Product Development Process.
    • Assist in regulatory submissions, as required.
  • Support and maintain device production and distribution activities
    • Facilitate and continually improve complaint handling system. Perform and coordinate investigations of product returns in a timely manner.
    • Review and approve release of or changes to specifications and drawings, evaluating design change impact, including effect on inspection, verification/validation, risk analysis, sterilization, and biocompatibility.
    • Identify areas requiring corrective and preventive action, including those resulting from non-conforming product. Coordinate activities associated with planning and implementing solutions.  Follow up, as required, to ensure effective implementation.
    • Provide data collection, review, and analysis of processes supporting production and product quality. Communicate information effectively
    • Quality representative for Material Review Board (MRB) activities.
  • Corrective and Preventive Action
    • Assist in maintenance of CAPA database and coordination of CAPA meetings.
    • Complete assigned CAPA actions.
    • Conduct and document verification of implementation and effectiveness of corrective and/or preventive actions.
  • Support and participate in inspection and test activities
    • Review and approve inspection requirements.
    • Assist in inspection processes through development of inspection tools and aides, (i.e., go/no go gages, visual standards, and reference samples)
    • Review and approve first article inspections
    • Determine compliance to specifications.
  • Support Quality Management System
    • Perform or assist in hosting internal and external audits according to approved schedule.
    • Create/revise SOPs and work instructions.
    • Coordinate Training assignments.
  • Sterilization and Biocompatibility
    • Assist in coordinating the development of sterilization processes, validation, revalidation, and routine monitoring.
    • Review sterilization test results for final product release. This includes, but is not limited to, EO residuals, sterility, and bacterial endotoxins (pyrogen).
    • Assist in determining applicable biocompatibility requirements for US and international compliance. Coordinate biocompatibility testing with outside laboratories.
  • Monitors product and process performance metrics and acts upon trends (positive or negative)

MINIMUM QUALIFICATIONS 

Education*:

  • BS degree or equivalent in an engineering or life science discipline is required
  • Evidence of continued learning efforts a plus
  • ASQC CQA and/or CQE preferred

Experience*:

  • 3+ years progressively responsible experience operating as a Quality Engineer in a highly regulated manufacturing environment required.
  • 1+ years working in an FDA regulated environment optimal

Skills and Competencies:

  • Experience with risk analysis and reliability engineering techniques.
  • Identifying requirements, setting realistic scheduling and meeting deadlines.
  • Ability to identify issues, determine root cause, and implement solutions.
  • Ensure compliance to standards, regulations and Company procedures.
  • Identify and facilitate process and SOP improvements within the Quality System, embracing a culture of continuous improvement.
  • Advanced Microsoft software skills including sophisticated Word, Excel and PowerPoint skills a must. Access, Visio, database and statistical analysis software experience optimal.
  • Sophisticated written and verbal communication skills, including previous experience in procedure, protocol and report writing required.
  • Must be highly and effectively organized as well as a flexible self‑starter, team-oriented, and excellent at prioritization and multitasking.
  • A natural at fostering collaborative relationships across all lines of the Company.

Other Considerations (travel/hours availability, etc.):

  • Some travel will be required (less than 5%)
  • Other projects and duties as necessary and assigned.

Ability to work overtime is required

PHYSICAL DEMANDS

  • Stand/Sit/Walk 8 hrs a day
  • Dexterity Required

WORK ENVIRONMENT

  • Chemicals/Solvents
  • Infectious Disease exposure
  • Radiation
  • Clean Room
  • Eye Protection

PURPOSE/SUMMARY

The Principal Quality Engineer supports the development and manufacture of Olympus Veran Technologies (OVT) products during all phases of design, development, production, and distribution.

PRIMARY DUTIES AND RESPONSIBILITIES

The Principal Quality Engineer is responsible for:
• Acting as the Quality Representative on Product Development project teams
• Working cross-functionally to generate and maintain product Risk Management file(s)
• Reviewing QMS and product Design Changes
• Defining Inspection and test methods and systems
• Complaint handling and product investigations of device returns
• Support continuous improvement opportunities
• Preparing and maintaining Quality Metrics
• Maintenance of Quality Management System by ensuring compliance to U.S. and international regulatory requirements for medical devices
• Serves as a mentor for the Quality Engineering team to assist in developing Quality Engineering skills
• Leads complex product projects through completion by collaborating with various functions to ensure that all project requirements are met.
• Support design and development projects
o Represent the Quality team. Provide input and coordinate activities related to:
 Risk analysis activities (design and process FMEAs).
 Oversight of verification and validation activities.
 Acceptance criteria and inspection methods of components and assemblies.
 Product labeling and specifications.
o Review Design History File.
o Provide project team with guidance on compliance to Product Development Process.
o Assist in regulatory submissions, as required.
• Support and maintain device production and distribution activities, addressing quality issues and resolution using the current quality techniques and principles.
o Facilitate and continually improve complaint handling system. Perform and coordinate investigations of product returns in a timely manner.
o Review and approve release of or changes to specifications and drawings, evaluating design change impact, including effect on inspection, verification/validation, risk analysis, sterilization, and biocompatibility.
o Identify areas requiring corrective and preventive action, including those resulting from non-conforming product. Coordinate activities associated with planning and implementing solutions. Follow up, as required, to ensure effective implementation.
o Provide data collection, review, and analysis of processes supporting production and product quality. Communicate information effectively
o Quality representative for Material Review Board (MRB) activities.
• Corrective and Preventive Action
o Participates in the CAPA process as required as an assignee or project team lead.
• Support and participate in inspection and test activities
• Support Quality Management System
• Creates product and process performance metrics and acts upon trends with minimal guidance. Monitors product and process performance metrics and acts upon trends (positive or negative).
• Develops and drives measurable Quality improvement relation to products processes and services.

Apply Now

Location: St. Louis, MO
Listing Date: June 9, 2021
Position: Principal Quality Engineer
Job Type: Full-Time
Education: BS degree or equivalent in an engineering or life science discipline. Master’s Degree preferred.
Direct Report: Vice President of Quality Assurance & Regulatory Affairs

MINIMUM QUALIFICATIONS

Education*:
• BS degree or equivalent in an engineering or life science discipline. Master’s Degree preferred.
• Evidence of continued learning efforts a plus.
• ASQ CQA and/or CQE a plus

Experience*:
• 12+ years progressively responsible experience operating as a Quality Engineer in a highly regulated manufacturing environment or equivalent experience required.
• 7+ years working in an FDA regulated environment optimal (5+ years required).
• Leadership Experience: proven ability to lead and mange cross-functional teams, effectively communicate with all levels of management and drive effective change

Skills and Competencies:
• Knowledge of ISO 13485, 21 CFR Part 820, 93/42/EEC Medical Devices Directive, EU Regulation 2017/745, SOR 98/282, Canadian Medical Device Regulations, 21 CFR Part 11, ISO 14971, ISO 11135, ISO 10993-1, ISO 11607 and other medical device industry US and international standards.
• Experience with risk analysis and reliability engineering techniques.
• Identifying requirements, setting realistic scheduling, and meeting deadlines.
• Ability to identify issues, determine root cause, and implement solutions.
• Ensure compliance to standards, regulations, and Company procedures.
• Identify and facilitate process and SOP improvements within the Quality System, embracing a culture of continuous improvement.
• Advanced Microsoft software skills including sophisticated Word, Excel and PowerPoint skills preferred. Access, Visio, database, and statistical analysis software experience optimal.
• Sophisticated written and verbal communication skills, including previous experience in procedure, protocol and report writing required.
• Must be highly and effectively organized as well as a flexible self starter, team-oriented, and excellent at prioritization and multitasking.
• A natural at fostering collaborative relationships across all lines of the Company.

Other Considerations (travel/hours availability, etc.):
• Some travel will be required (less than 5%)
• Some extended workdays may be required
• Other project and duties as assigned.

PURPOSE/SUMMARY

The Sr. Quality Engineer supports the development and manufacture of Olympus products during all phases of design, development, production, and distribution.

PRIMARY DUTIES AND RESPONSIBILITIES

The Sr. Quality Engineer is responsible for:
• Acting as the Quality Representative on Product Development project teams
• Working cross-functionally to generate and maintain product Risk Management file(s)
• Reviewing QMS and product Design Changes
• Defining Inspection and test methods and systems
• Complaint handling and product investigations of device returns
• Support continuous improvement opportunities
• Preparing and maintaining Quality Metrics
• Maintenance of Quality Management System by ensuring compliance to U.S. and international regulatory requirements for medical devices
• Serves as a mentor for the Quality team, when necessary, to assist in developing Quality Engineering skills
• Support design and development projects
o Represent the Quality team. Provide input and coordinate activities related to:
 Risk analysis activities (design and process FMEAs).
 Oversight of verification and validation activities.
 Acceptance criteria and inspection methods of components and assemblies.
 Product labeling and specifications.
o Review Design History File.
o Provide project team with guidance on compliance to Product Development Process.
o Assist in regulatory submissions, as required.
• Support and maintain device production and distribution activities
o Facilitate and continually improve complaint handling system. Perform and coordinate investigations of product returns in a timely manner.
o Review and approve release of or changes to specifications and drawings, evaluating design change impact, including effect on inspection, verification/validation, risk analysis, sterilization, and biocompatibility.
o Identify areas requiring corrective and preventive action, including those resulting from non-conforming product. Coordinate activities associated with planning and implementing solutions. Follow up, as required, to ensure effective implementation.
o Provide data collection, review, and analysis of processes supporting production and product quality. Communicate information effectively
o Quality representative for Material Review Board (MRB) activities.
• Corrective and Preventive Action
o Assist in maintenance of CAPA database and coordination of CAPA meetings.
o Complete assigned CAPA actions.
o Conduct and document verification of implementation and effectiveness of corrective and/or preventive actions.
• Support and participate in inspection and test activities
o Review and approve inspection requirements.
o Assist in inspection processes through development of inspection tools and aides; i.e., go/no go gages, visual standards, and reference samples
o Review and approve first article inspections
o Determine compliance to specifications.
• Support Quality Management System
o Assist in hosting internal and external audits according to approved schedule.
o Create/revise SOPs and work instructions.
o Coordinate Training assignments.
• Sterilization and Biocompatibility
o Assist in coordinating the development of sterilization processes, validation, revalidation, and routine monitoring.
o Review sterilization test results for final product release. This includes, but is not limited to, EO residuals, sterility, and bacterial endotoxins (pyrogen).
o Assist in determining applicable biocompatibility requirements for US and international compliance. Coordinate biocompatibility testing with outside laboratories.
• Monitors product and process performance metrics and acts upon trends (positive or negative).

Apply Now

Location: St. Louis, MO
Listing Date: June 9, 2021
Position: Sr. Quality Engineer
Job Type: Full-Time
Education: BS degree or equivalent in an engineering or life science discipline is preferred.
Direct Report: Principal Quality Engineer

MINIMUM QUALIFICATIONS

Education*:
• BS degree or equivalent in an engineering or life science discipline is preferred.
• Evidence of continued learning efforts a plus.
• ASQ CQA and/or CQE a plus
Experience*:
• 5+ years progressively responsible experience operating as a Quality Engineer in a highly regulated manufacturing environment or equivalent experience required.
• 3+ years working in an FDA regulated environment optimal (1+ years required)
Skills and Competencies:
• Knowledge of ISO 13485, 21 CFR Part 820, 93/42/EEC Medical Devices Directive, EU Regulation 2017/745, SOR 98/282, Canadian Medical Device Regulations, 21 CFR Part 11, ISO 14971, ISO 11135, ISO 10993-1, ISO 11607 and other medical device industry US and international standards.
• Experience with risk analysis and reliability engineering techniques.
• Identifying requirements, setting realistic scheduling and meeting deadlines.
• Ability to identify issues, determine root cause, and implement solutions.
• Ensure compliance to standards, regulations and Company procedures.
• Identify and facilitate process and SOP improvements within the Quality System, embracing a culture of continuous improvement.
• Advanced Microsoft software skills including sophisticated Word, Excel and PowerPoint skills preferred. Access, Visio, database and statistical analysis software experience optimal.
• Sophisticated written and verbal communication skills, including previous experience in procedure, protocol and report writing required.
• Must be highly and effectively organized as well as a flexible self starter, team-oriented, and excellent at prioritization and multitasking.
• A natural at fostering collaborative relationships across all lines of the Company.
Other Considerations (travel/hours availability, etc.):
• Some travel will be required (less than 5%)
• Some extended workdays may be required
• Other project and duties as assigned.

It is the policy of Veran to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law. In addition, Veran will provide reasonable accommodations for qualified individuals with disabilities.

Interested applicants should submit all materials through the Veran Career portal. Veran reserves the right to reject or refuse consideration of any materials sent directly to Human Resources or any other Department in lieu of the formal online application process.

Think you might be a good fit? We’d like to hear from you.