Veran^® Careers

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.  Software Engineers may be called upon to implement challenging algorithm and general software engineering problems with little supervision.  Additionally, final tier support for reported field issues /complaints may be required.

Location: Golden, CO
Listing Date: February 11, 2021
Position: 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 a plus.
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
• 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
• 0-5 years of professional software development experience required
• Previous experience working in a medical device company a plus

 Skills & Competencies:

• Interest and/or some experience in one or more of the following fields preferred
  • Image processing algorithms (segmentation, volume rendering, linear algebra, etc.)
  • Digital Signal Processing (filtering, acquisition, etc)
  • AI networks, training, user interfaces
• Interest and/or some experience with one or more of the following tools a plus
  • OpenGL
  • Qt – for application and GUI development
• Hard working, intelligent, technical acumen, self-motivated, ability to multitask
• Operate with little or no supervision
• 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. 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.

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.  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.   Principal Software Engineers are called upon to take leadership roles in developing algorithms and software applications from the ground up, with little or no technical supervision.  Novel algorithm, software, and intellectual property development is required.  They are expected to interface directly with clinicians and upstream marketing to lead the way in ground-breaking new medical device technologies.

Location: Golden, CO
Listing Date: February 11, 2021
Position: Principal Software Engineer
Job Type: Full-Time
Education: BS degree in Electrical Engineering, Computer Science, Applied Mathematics or related field required. MS or PhD required, although significant related industry experience is acceptable in lieu of.
Direct Report: Vice President, Application Development

PRIMARY DUTIES AND RESPONSIBILITIES

• Top leadership roles in the research, development and release of new software and/or medical devices to assist physicians with detection and diagnosis of lung cancer
• Research and Development principal responsibilities, including:
  • Interface with clinicians and upstream marketing, doing initial development of novel, ground-breaking software algorithms and clinical devices/applications
  • Establishment and leadership of new projects according to established design control and quality procedures
  • Successful execution of 510k and/or PMA applications in conjunction with Regulatory
• 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
• Explore and document intellectual property in the creative solution to design challenges

SUPERVISOR RESPONSIBILITIES

• Principal Engineers may have recruiting, hiring, and direct reporting of other Engineering personnel

MINIMUM QUALIFICATIONS

Experience*:

• Programming experience in MATLAB or C/C++ required
• 15+ years of professional software development experience required (medical device field strongly preferred)
• Previous experience working in Image Guided Surgery, Ultrasound, or Artificial Intelligence projects in industry or academia strongly preferred

Skills & Competencies:

• Hard working, intelligent, technical acumen, self-motivated, ability to multitask
• Experience with Medical Device Design Control preferred
• Experience implementing high performance numerical algorithms on various computing platforms preferred
• Experience with MATLAB preferred
• Experience with GUI design/implementation (particularly using the Qt Framework) preferred
• 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.

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

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

Assist the Manager, Regulatory Affairs in obtaining approval to market Olympus medical devices and maintaining regulatory compliance in the markets served by Olympus

Location: St. Louis, MO
Listing Date: March 15, 2021
Position: Specialist II, Regulatory Affairs
Job Type: Full-Time
Education: Regulatory affairs experience in the Medical Device industry is mandatory [minimum 3 years with BS/BA or 1 year with MS preferred].
Direct Report: Manager, Regulatory Affairs

PRIMARY DUTIES AND RESPONSIBILITIES

• Participate in product teams developing new products. As needed, provide input to define global regulatory strategy requirements.
• Participate in teams for sustaining products to provide input on impact to global regulatory requirements.
• Knowledge of FDA medical device regulations, guidance, and other applicable standards to develop, coordinate, prepare and maintain US medical device submissions such as 510ks and Pre-Submissions, and liaise with FDA reviewers as needed.
• Knowledge of Medical Device Regulation (2017/745) guidance, and applicable standards including ISO 13485 to support preparation of dossiers and technical files for registration of Olympus products in the EU and liaise with notified body as needed.
• Knowledge of Canadian Medical Device Regulations, guidance and other applicable standards to develop, coordinate, prepare and maintain medical device submissions for Canadian Class 2, 3 or 4 Device License submissions, and liaise with Health Canada agents as needed.
• Support preparation of dossiers for registration for other international markets such as Japan, Asia Pacific Australia and Latin America.
• Assist with maintenance of regulatory files and databases to ensure prompt and accurate access to company regulatory information. Provide dashboard updates concerning current, pending, and future approvals for Regulatory Affairs management.
• As needed, assist in the development and maintenance of regulatory procedures to assure consistent, efficient and compliant regulatory processes.
• Work closely with Marketing in developing labeling materials.

MINIMUM QUALIFICATIONS

• Regulatory affairs experience in the Medical Device industry is mandatory [minimum 3 years with BS/BA or 1 year with MS preferred].
• BS/BA required, preferably in engineering or life sciences. RAC accreditation a plus.
• Strong written and verbal communication skills.

PHYSICAL DEMANDS

• Stand/Sit/Walk 8 hrs a day

Location: St. Louis, MO
Listing Date: April 9, 2021
Position: Project Manager (QA/RA)
Job Type: Full-Time
Education: • BS Degree in Technical Field required
Direct Report: VP, QA/RA (OVT)

PRIMARY DUTIES AND RESPONSIBILITIES
• Assists in the development and implementation of project plans, including cost, schedule, risk and performance for projects/programs.
• Collect dashboard Key Performance Indicators from all key functions, including dashboard executive summaries and project highlights.
• Creation of presentations both scheduled and ad hoc as business needs arise
• Create agendas for team meetings and publish minutes/actions.
• Conduct routine cross functional team meetings to ensure accountability and milestone achievements.
• With guidance lead in the development of a Quality Plan(s) and schedule for assigned projects.
• Follow up on project related actions and deliverables, escalating issues proactively as they arise.
• With guidance, develop and manage budgets for the project including resource loading, external expenses and capital requirements.
• Actively seek collaboration and build relationships with internal customers to improve overall outcomes and timely project completion
• Other Essential Duties as directed.

MINIMUM QUALIFICATIONS 

Education*:

• BS Degree in Technical Field required

Experience*:

• 3+ years of experience in the medical device field preferably in a Quality and/or Regulatory role.
• Experience with applicable FDA guidance’s, ISO 13485 regulations and applicable industry standards.

Skills & Competencies:

• Demonstrated planning and project management principles, practices, techniques and tools
• Proven ability to manage multiple projects involving numerous internal and external stakeholders.
• Must be able to work independently and be self-motivated with a strong sense of urgency
• Ability to work in an environment with competing priorities; effective at dealing with change and flexibility while responding well under pressure and ensuring compliance.
• Strong communication skills with the ability to present to small and large teams.
• Proficient in Excel, Microsoft Project, Power Point, Visio, and Word.
• PMP certification preferred.
• Ability to understand and translate domestic and international requirements to practical deliverables.

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

• Travel to other Company facilities, vendors, etc. may be required; up to 10% domestic travel

Other projects and duties as necessary and assigned.

Bend/Stoop/Kneel 2 hrs a day

Stand/Sit/Walk 8 hrs a day