The Senior Engineer, R&D will work with other members of the product development team to conceive, develop, prototype, test and debug novel catheter systems in accordance with established policies, goals, and objectives; must have the ability to make sound technical decisions, prioritize project deadlines, follow up and complete critical items; required to quickly generate numerous design concepts, narrow down, and select the best option through an appropriate mix of analysis and prototyping; ability to motivate others to reach timelines and deliverables of the projects from concept to commercialization.

Core Job Responsibilities:

• Design prototypes and feasibility models for proof-of-concept testing
• Design and document catheter prototypes through production released products.
• Support efforts to verify and validate new product designs
• Help prepare project plans, specifications, and schedules for new product development
• Prepare and manage Test Protocols, Reports and lab notebooks
• Identify and interact with vendors to obtain engineering materials, processes, and equipment
• Perform routine analysis of test results in relation to design specifications and test objectives
• Assist Engineering Team in maintaining adequate inventory of engineering and prototype materials
• Work closely with other engineers, technicians, contract manufacturers, assemblers, or other support personnel to assist in debugging and optimizing system performance
• Assist in the preparation and review of patent applications
• Support manufacture of new and existing products
• Stay current with general engineering knowledge related to catheter design
• Other duties as assigned

Requirements:

• 5+ years’ experience as an engineer in the medical device industry required
• Bachelor’s degree in Mechanical Engineering or Biomedical engineering required; Master’s degree preferred
• Must have a demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams
• Team player able to work cross functionally
• Must have strong analytical and problem-solving skills, as well as a good background in the product development process
• Extensive knowledge and proven track record of complex Catheter design, Manufacturing process skills and rapid product development.
• Familiar with PC-based office computers including familiarity with Microsoft Word, Excel, PowerPoint, and Outlook.
• Expertise in SolidWorks
• Experience working with ISO requirements, GMP guidelines, FDA regulations, medical device design control, and manufacturing scale-up processes
• Previous start-up experience, a plus
• Prior experience with atherectomy catheter and related component design such as high speed drive shaft, handle, and drive mechanism is a plus.
• Strong understanding of engineering materials, component selection, and design for reliability and manufacturability.
• Strong creative ability (as demonstrated by a number of patents) as well as IP knowledge is a plus

• Understand the job specific quality system procedures and processes as defined in the Training Matrix and adhere to the requirements listed in those documents.
• Maintain corporate confidentiality at all times.

Living Avinger’s Culture:

As a member of the Avinger team, employees agree to embrace and live out the core values of Avinger, which are:

The R&D Engineer will work with other members of the product development team to conceive, develop, prototype, test, and debug novel catheter systems in accordance with established policies, goals, and objectives; Must have ability to follow up and complete project tasks such as CAD modeling, prototyping, testing, and completing test reports.

Core Job Responsibilities:

• Support product development team to complete project development tasks based on project goals.
• Conduct testing utilizing established test protocols.  Demonstrate understanding of experimental design. Accurately generate standard written reports.  Develop tests methods and write test protocols and test reports.
• Maintain a controlled lab notebook for purposes of accurate documentation of concepts, designs, drawings, and processes.
• Create and update solid models and drawings and prepare material for Change Order release.
• Obtain working knowledge of QSR systems, including pre-production quality assurance. procedures, pre-clinical testing programs, and post-production QSR compliance in coordination with the Document Control, Clinical, and Quality Assurance functions.

Requirements:

• B.S. in Mechanical or Biomedical Engineering is required; M.S. preferred.
• 0-2 years of experience in medical device development.
• Comprehensive knowledge of CAD and drafting tools such as Solidworks.
• Hands-on experience making prototypes and assembling devices is a plus.
• Familiar with PC-based office computers including familiarity with Microsoft Word, Excel, PowerPoint, and Outlook.
• Use good judgment, initiative and analytical abilities, to accomplish short and long-range projects. Provide guidance to technicians as needed.

• Learn and understand the job specific quality system procedures and processes as defined in the Training Matrix and adhere to the requirements listed in those documents.
• Multitasks, prioritizes, and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Participate in the project meeting through out product development cycle and cooperate with the cross-functional department such as quality and operations.
• Maintain corporate confidentiality at all times.

As a member of the Avinger team, employees agree to embrace and live out the core values of Avinger, which are:

Leads and Manages a sales force to achieve sales and profit goals within the designated/assigned US geography.

Core Job Responsibilities:

• Develops strategic sales and marketing objectives, establishes sales territories and quotas; adjusts sales goals and procedures as appropriate for their region.
• Manages budgets and evaluates sales performance based on corporate guidance.
• Designs and recommends sales programs and sets short and long-term sales strategies.
• Evaluates and implements appropriate sales techniques to increase sales volume and successful clinical outcomes.
• Recommends product or service enhancements to improve customer satisfaction and sales potential as needed.
• Ensures projects are completed on time and within budget in accordance with corporate objectives.
• Acts as advisor to sales team regarding projects, tasks, and operations.
• Leads and develops assigned team to continually improve performance, evaluate strengths and developmental needs; provides appropriate feedback, coaching and mentoring to ensure high levels of performance within the reporting function.
• Maintains a superior level of knowledge of the applications related to Avinger products and of the business needs of multi-hospital organizations to assure effective representation in the marketplace.
• Identifies and resolves customer issues and sales related difficulties.
• Monitors market, customer and competitor trends and advise management on methods to improve company competitiveness.  Provides feedback to assist in the determination of optimal multi-hospital account strategies.
• Identifies opportunities to expand and secure regional account business through contracts, programs, or other initiatives.  Develops proposals, bids, pricing, programs, and contracts with support from Avinger sales and marketing management.  Negotiates customer agreements that are acceptable to the interests of the Company.
• Has a solid understanding of National Accounts, IDNs, physician offices and GPOs and be able to utilize those respective resources to drive new business growth.
• Other duties as assigned.

Requirements:

• BA/BS in business or equivalent combination of education and experience.
• A minimum of 7-10 years of related cross functional sales, marketing, operational and sales management experience is required with a successful track record, along with a thorough knowledge of the high-tech medical device market, products, and customers.
• Travel to customer facilities on a regular basis throughout the assigned territory, with trips by air or car, around 40% of the time to support the territory; may travel to the corporate office, trade shows, or other locations throughout North America, as needed.
• Must be a team builder, team player, and strong leader, able to build consensus.
• Exceptional communication and platform presentation skills.
• A strong work ethic, self-motivation, and entrepreneurial drive are required, as are high personal values and standards.  Honesty, integrity, the ability to work with minimal supervision, a conscientious approach to meeting goals and objectives, and the ability to handle pressure with grace and humor are equally important.
• Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis.
• Business Acumen – Knows how business work; knowledgeable in current and possible future policies, practices, trends, technology and information affecting his/her business and organization; knows the competition.
• Can negotiate skillfully in tough situations with both internal and external groups; can settle differences with minimum noise; can win concessions without damaging relationships; can both be direct and forceful as well as diplomatic; has a good sense of timing.
• Ability to work in the interest of all of Avinger.  Additionally, a successful individual will need to align and coordinate the activities for Avinger at multiple levels, Direct Sales, Distributors, Marketing, Network Channels, etc.  Being able to consider the implications for these various areas and determining the best course of action will require the ability to understand complex situations and coordinate efforts across multiple organizational resources.
• Proficiency with PC or Mac-based office computers, including familiarity with Microsoft Word, Excel, PowerPoint, and Outlook required.

• Understand the job specific quality system procedures and processes as defined in the Training Matrix and adhere to the requirements listed in those documents.
• Maintain corporate confidentiality at all times.

As a member of the Avinger team, employees agree to embrace and live out the core values of Avinger, which are:

Primary responsibility is to drive Lumivascular therapy utilization through case coverage and supporting marketing and training events.

Core Job Responsibilities:

• Partner with the Territory Sales Representative to execute sales plan tailored to the assigned territory/accounts
• Become an expert of Avinger products and the marketing programs to assist in the development of surgical teams to treat peripheral artery disease (PAD)
• Work with senior hospital staff and key surgeons in the development and execution of a plan to effectively integrate the marketing programs at new customer sites, ensuring ongoing commitment to the products
• Instruct physicians on products and drive utilization by collaborating with surgical teams
• Manage and oversee marketing programs from beginning to end and track results
• Other duties as assigned

Requirements:

• 3 to 5-years of successful experience in a clinical role (Catheter Lab or Operating Room Technician)
• Bachelor’s degree preferred or equivalent, relevant sales and industry experience
• Working knowledge of the catheter lab and operating room environment
• 3+ years of work experience in endovascular space preferred
• Understanding of endovascular anatomy, physiology and terminology preferred
• Good knowledge of endovascular procedures preferred
• Solid verbal/written communication and interpersonal skills to work across multiple constituents
• Team player
• Self-starter with ability to take leadership in an unstructured environment
• Able to prioritize and productively manage multiple tasks
• Desire to work in an open, collaborative, and fast-paced environment
• Willingness to develop creative solutions to overcome challenges
• Proven ability to influence cross-functional teams with and without formal authority
• Accustomed to and anticipates travel (30%+)

• Understand the job specific quality system procedures and processes as defined in the Training Matrix and adhere to the requirements listed in those documents.
• Maintain corporate confidentiality at all times

As a member of the Avinger team, employees agree to embrace and live out the core values of Avinger, which are:

Position Summary:

The Manager, Product Marketing is a key strategic position that will serve as the functional lead for product manager responsibilities, including technical project management, working with other members of the team on product launch, developing sales training and enablement tools, and acting as customer facing representation of Avinger. This position will be pivotal in moving marketing initiatives forward, with an emphasis on upstream marketing projects, cross-functional project management, and defining the product strategy and roadmap. In partnership with the Chief Marketing Officer, and other members of the marketing team, the Manager, Product Marketing will own deliverables throughout the product lifecycle, gathering and prioritizing product and customer requirements, defining the product vision, working closely with engineering to deliver patient-focused products, coordinating product launches, and partnering with the sales team to deliver on revenue and customer adoption goals. The Manager, Product Marketing will work with members of the product development team to assist in managing projects in accordance with established objectives.

Core Job Responsibilities:

• Own the product management life cycle through feasibility, development, commercialization, and post-commercialization to ensure target sales and gross profit objectives are achieved.
• Develop and maintain an understanding of the vascular interventional space, including current and future market trends, market size estimates, products, and competitors.
• Create go-to-market strategies for new product launches and line extensions. Lead the commercial launch strategy and execution incorporating brand positioning, pricing recommendations, product features, distribution channels, and product forecasting.
• Maintain a thorough understanding of the future pipeline of products and their characteristics and requirements, e.g., patent issues, competitive landscape, manufacturing challenges, pricing and market dynamics, and barriers to entry. Create business cases for sanctioning new products, which include market analysis, development timelines, key milestones, forecasted revenues and project costs, key stakeholders, risks, manufacturing considerations, and sales and marketing plans.
• Conduct continuous surveillance of the market landscape in order to assess and make recommendations of future product needs to help achieve business goals. Define market research needs and work with Chief Marketing Officer and Chief Medical Officer to design research studies to inform customer requirements and product development.
• Act as cross-functional project manager in the product development process, working with cross-functional team to develop key milestones, budgets, timelines, and project management tools to ensure on-time and on-budget delivery.
• Work in collaboration with a cross-functional team to make go/no go recommendations on new pipeline product as well as assess the market potential for creative line extensions that augment Avinger’s competitive advantage.
• Partner with finance team in regular forecasting cycles to derive market and product assumptions. Collaborate cross-functionally to align forecasting goals between marketing and production. Work with manufacturing, supply chain, and customer service to ensure accurate and timely forecasting for new and existing products. Includes monthly analysis of key variances and market drivers to help improve forecast accuracy.
• Define, validate, and drive the development of sales and marketing communications, sales enablement tools, sales training modules and collateral to drive utilization and adoption of Avinger technology.
• Provide recommendations for potential clinical trials or case series that could support additional indications or literature to drive further adoption of Avinger technology.
• Act as key clinical resource for direct sales force on Avinger products, develop understanding of standard treatment paradigms, and become a product positioning expert.
• Identify and resolve emerging issues that may impact project, department or corporate goals. Recognize potential threats to success and elevate issues to senior management when appropriate. Propose solutions, resolve conflicts within cross functional teams when possible and make recommendations for process improvements.
• Other duties as assigned.

Other Responsibilities:

• Understand the job specific quality system procedures and processes as defined in the Training Matrix and adhere to the requirements listed in those documents.
• Maintain corporate confidentiality at all times.

Requirements:

• Bachelor’s degree or combination of equivalent work experience; advanced degree in Business or Engineering field is a plus
• Minimum of 5+ years’ experience as a Product Manager, or Product Marketing Manager, preferably in the medical device or life sciences industry, demonstrating increasing levels of responsibilities
• Previous experience working cross functionally within all levels of an organization (Sales, Engineering, Operations, Manufacturing, Customer Service) preferably in the medical device industry
• Demonstrated aptitude to define and launch excellent products
• Strong communication, presentation and writing skills
• Excellent teamwork skills and strong desire to collaborate
• Desire to work in an open start up environment with ability to wear multiple hats
• Willingness to develop creative solutions to overcome challenges
• Proven ability to influence cross-functional teams without formal authority
• Ability to engage with external customer groups
• Proactive, with exceptional organizational skills, having the ability to multitask and manage multiple projects under minimal supervision
• Must be available for occasional travel

Nice to Haves:

• Previous experience in the vascular or coronary interventional space
• Previous product launch experience, preferably in the medical device industry

Living Avinger’s Culture:

As a member of the Avinger team, employees agree to embrace and live out the core values of Avinger, which are:

• Patient first
• Collaborate
• Educate
• Be open-minded

Primary responsibility is to drive Lumivascular therapy utilization through case coverage and supporting marketing and training events.

Core Job Responsibilities:

• Partner with the Territory Sales Representative to execute sales plan tailored to the assigned territory/accounts
• Become an expert of Avinger products and the marketing programs to assist in the development of surgical teams to treat peripheral artery disease (PAD)
• Work with senior hospital staff and key surgeons in the development and execution of a plan to effectively integrate the marketing programs at new customer sites, ensuring ongoing commitment to the products
• Instruct physicians on products and drive utilization by collaborating with surgical teams
• Manage and oversee marketing programs from beginning to end and track results
• Other duties as assigned

Requirements:

• 3 to 5-years of successful experience in a clinical role (Catheter Lab or Operating Room Technician)
• Bachelor’s degree preferred or equivalent, relevant sales and industry experience
• Working knowledge of the catheter lab and operating room environment
• 3+ years of work experience in endovascular space preferred
• Understanding of endovascular anatomy, physiology and terminology preferred
• Good knowledge of endovascular procedures preferred
• Solid verbal/written communication and interpersonal skills to work across multiple constituents
• Team player
• Self-starter with ability to take leadership in an unstructured environment
• Able to prioritize and productively manage multiple tasks
• Desire to work in an open, collaborative, and fast-paced environment
• Willingness to develop creative solutions to overcome challenges
• Proven ability to influence cross-functional teams with and without formal authority
• Accustomed to and anticipates travel (30%+)

• Understand the job specific quality system procedures and processes as defined in the Training Matrix and adhere to the requirements listed in those documents.
• Maintain corporate confidentiality at all times

As a member of the Avinger team, employees agree to embrace and live out the core values of Avinger, which are:

Primary responsibility is to drive new account acquisition and market expansion within a designated geography while routinely providing case support at the direction of the Territory Sales Manager (TSM) / Regional Director (RD).

Core Job Responsibilities:

• Become an expert on Avinger product features and product training to assist in the development of interventional teams treating peripheral artery disease (PAD)
• Partner with the Territory Sales Manager to develop sales strategies and plans tailored to the assigned territory, accounts, and geography
• Execute growth-based sales strategy to expand the Avinger account base and utilization within existing accounts
• Cultivate and develop sales prospects, qualify leads, and effectively communicate Avinger’s value proposition to potential customers
• Instruct physicians on the proper use of Avinger products, establish strong clinically-based rapport with physicians, and drive technology adoption
• Manage and oversee local marketing programs from beginning to end and track results
• Other duties as assigned

Requirements:

• 1-2 years of successful sales experience in a medical device-based organization
• Bachelor’s degree preferred or equivalent, relevant sales and industry experience
• Working knowledge of the hospital environment
• 3+ years of total work experience in medical device space preferred
• Understanding of endovascular procedures, peripheral artery anatomy, physiology and terminology preferred
• Solid verbal/written communication and interpersonal skills to work across multiple constituents
• Bilingual in Spanish language preferred
• Team player with strong integrity
• Self-starter with ability to take leadership in a less structured environment
• Able to prioritize and productively manage multiple tasks
• Desire to work in an open, collaborative, and fast-paced environment
• Willingness to develop creative solutions to overcome challenges
• Proven ability to influence cross-functional teams with and without formal authority
• Accustomed to and anticipates travel (30%+)

• Understand the job specific quality system procedures and processes as defined in the Training Matrix and adhere to the requirements listed in those documents.
• Maintain corporate confidentiality at all times

As a member of the Avinger team, employees agree to embrace and live out the core values of Avinger, which are:

The Customer Service Representative is responsible for certain day-to-day functions of the Customer Service department. Some functions include support for Avinger’s Sales Team, Customer support via phone or email, trunk stock inventory management and auditing. This position will also work with the Customer Service Manager to ensure accurate reporting and maintenance of the Customer Database. The role is part-time and requires the person to work on site. This is not a remote position..

Core Job Responsibilities:

• Processing orders, processing RMAs, trunk stock shipments, trunk stock inventory shipments
• Ensure all necessary paperwork and data entry is completed accurately to facilitate efficient delivery of orders placed and accounts receivable invoicing.
• Ensure customer satisfaction is obtained through effective communication, problem solving professional phone etiquette and efficient processes
• Maintain accurate and up-to-date Customer Files
• Complete all necessary steps of processing an order on a daily basis in a complete and accurate manner
• Handling incoming/outbound calls in a professional manner
• Comply with and adhere to all regulatory compliance areas, policies and procedures
• Other duties as assigned.

Requirements:

• College degree preferred
• 4 years of experience in a medical device customer service role preferred
• Excellent verbal and written communication skills
• Excellent teamwork skills; ability to make quick changes per the needs of the team at large
• Ability to multi-task and be a self-starter; maintain a high level of adaptability / flexibility
• Strong working knowledge of MS Office applications
• Experience with ERP system customer service module (SAP B1 ERP preferred or equivalent).

• Understand the job specific quality system procedures and processes as defined in the Training Matrix and adhere to the requirements listed in those documents.
• Maintain Corporate confidentiality at all times.

As a member of the Avinger team, employees agree to embrace and live out the core values of Avinger, which are:

• Patients first
• Collaborate
• Educate
• Be open-minded