Career Opportunities

Reports to: Director, Market Development, Marketing Department
Status: Regular, Full Time, Exempt, Field
Location: Northeastern and Southeastern Region

Job Summary: The Market Development Manager will focus on increasing utilization with both existing and new customers through the implementation of program development and integrated marketing initiatives with targeted customers (hospitals, medical facilities, physicians, office staff, etc.). The position works closely with the Program Development Managers (PDMs) who manage aligned territories and customers to ensure alignment of account level goals, strategies, and tactics.

Job Responsibilities:

• Utilize established processes and programs to coach PDM’s, customers and hospital marketing personal to develop local marketing strategies and plans that align with customer objectives, budget and capabilities.
• Develop and implement Program Development plans designed to increase TIF procedure volume with targeted customers
• Collaborate with Regional Managers and Program Development Managers on customer specific strategies and tactics
• Follow-up with customers on agreed upon execution plan with the goal of creating month-over-month procedure volume growth
• Establish metrics with each customer and follow-up to collect data for analysis.
• Implement local digital marketing programs that simultaneously promote our customers and our technology
• Educate and train physicians and medical staff on best practices for marketing the TIF procedure
• Other projects and assignments as required

Position Qualifications:

• Bachelor’s Degree in Business, Marketing, Communications, or related field
• Three to five years’ related marketing experience in a medical device, pharmaceutical, or other high growth industry required
• Demonstrated ability to work collaboratively and independently in a cross-functional and team-oriented environment
• Ability to collect and synthesize local market trends and competitive intelligence into actionable input for the marketing/sales teams
• Requires selling skills as well as negotiation and consulting skills
• Provide exceptional customer service to internal and external stakeholders
• Demonstrated knowledge of medical terminology, anatomy and physiology
• Experience in delivery of effective technical product information
• Strong interpersonal and persuasive communication skills required
• Must be highly resourceful and demonstrate ability to take initiative in the development and completion of projects
• High proficiency in PC software applications (Word, Excel, PowerPoint, Video editing, Video Conferencing)
• Knowledge of Salesforce.com
• Overnight travel as required
• Ability to perform public speaking at various venues

EndoGastric Solutions, Inc. is a fast-growth medical technology company headquartered in Redmond, Washington. The company is revolutionizing the fields of upper gastroenterology diseases including gastroesophageal reflux disease (GERD) and other GI disorders.

Reports to: Regional Sales Manager
Status: Regular, Full Time, Exempt
Field Position Currently Available:

• San Francisco

Job Summary: Responsible for clinical support, revenue growth, and procedure growth through execution of a Go-Deep sales strategy in targeted accounts. Cross functional collaboration with Sales Leadership, Market Development Managers, and the Clinical Education team.

Job Responsibilities:

• Clinical Support:
  • Represents approximately 60% of job responsibility and focus
  • Support EGS procedures and customers as assigned by RM
  • Demonstrate product, procedure and clinical knowledge, and proper surgical application of Company product
  • Educate physicians, nurses, scrub techs and various staff members on proper safe and efficacious use of devices
  • Properly communicate dynamic functions of the EGS product line
• Sales Support:
  • Represents approximately 40% of job responsibility and focus
  • Build excellent customer relations with key physicians and hospital personnel
  • Proper allocation of time among target accounts based upon focused objectives and direction from RM and in collaboration with PDM
  • Support Go-Deep strategy in Targeted Accounts as assigned by RM
  • Maintain clinical preference for EGS products and procedure with targeted customers
  • Communicate competitive activity within assigned territories and hospital accounts to RM and PDM
  • Execute Playbook activities to drive Business Plans and key initiatives forward
  • Participate in Quarterly Business Reviews
• Operate within the confines of an approved budget
• Maintain Company property (i.e., demo supplies, promotional materials, etc.) in an orderly and serviceable condition
• Other projects and assignments as required

Position Qualifications:

• College Degree
• Sales and/or clinical training experience required
• Medical sales experience preferred
• GI or Surgical sales and/or clinical training experience preferred
• Operating Room coverage preferred
• Skills in the following areas are essential: must be a strong team player, geographically flexible, high competency to learn and demonstrate technical medical devices, persistent initiative, and results –focused
• Place high value on ethical standards
• Performs all Company business in accordance with all regulations and Company policy and procedures
• Salesforce and Microsoft Office knowledge
• Requires travel on routine basis up to 75% of time

Equipment to be used in Performance of Job

• Home office
• Computer/laptops/printer
• Cell Phone

EndoGastric Solutions, Inc. is a fast-growth medical technology company headquartered in Redmond, Washington. The company is revolutionizing the fields of upper gastroenterology diseases including gastroesophageal reflux disease (GERD) and other GI disorders.

Status: Full Time, Exempt
Location: Redmond, WA

Job Summary: Responsible for Company’s Regulatory Affairs programs and efforts managing submissions to regulatory authorities worldwide in compliance with FDA and OUS guidelines and regulations. Responsible for the global regulatory compliance. Plans, develops, and performs activities to support Regulatory submissions and inquiries compliantly. In addition, assists the Senior Director in support of Quality Assurance and Quality Systems objectives as appropriate.

Job Responsibilities:

• Develop regulatory strategies for new or modified products. Ensures alignment of regulatory strategy to business strategy across all functional areas.
• Prepares reviews and submits all necessary regulatory information to FDA and OUS regulatory bodies including but not limited to 510(k)’S, IDE’s, PMA’s, and other OUS requirements.
• Develop and implement checklists for use to include audit points covering FDA, OUS, and other international regulatory requirements, as appropriate.
• Provides regulatory direction and strategy to new product project teams.
• Reviews all promotional and advertising material and provides regulatory direction for communications to the sales force and training department relating to marketed products.
• Create and update Technical Documents, Clinical Evaluation Reports, Post-Market Clinical Follow-up and Periodic Safety Update Report following EU MDR requirements.
• Review all Change Notifications for regulatory requirements.
• Participates in new product development with core team as primary regulatory representative.
• Proposes the required regulatory component for each product development project plan.
• Keep informed of new and pending requirements by researching regulatory requirements germane to the company.
• Implements corporate regulatory policy by updating regulatory operating procedures and provides assistance to other departments within the company regarding regulatory aspects of product development.
• Reviews applicable FDA regulatory proceedings and maintains awareness of required regulatory changes as adopted and reports potential impact of changes to the Senior Director and communicates same to the senior leadership of the company.
• Address questions, observations and recommendations resulting from audit findings and provide expertise and assistance in formulating systemic, corrective, and preventive action for any findings to ensure regulatory compliance as applicable.
• Manages regulatory compliance inquiries and visits to insure a satisfactory resolution to any issues.
• Create, update, and revise SOPs as needed to ensure Regulatory compliance as applicable.
• Works under direct supervision of the Senior Director in communicating directly with regulatory agencies, ensuring the success of regulatory submissions and filings.
• Other assignments and projects as directed.

Position Qualifications:

• Bachelor’s degree required (Life Science preferred)
• Minimum five years regulatory experience with FDA and ISO regulations and a strong knowledge of the medical device industry.
• FDA 510(k) submission experience required
• Extensive current knowledge of FDA, device pre-market notification and device CE certification requirements for the European Union.
• Regulatory project management experience required; supervisory management experience preferred
• Strong communication, team building, written and verbal communication skills, and interpersonal & problem-solving skills
• Ability to exercise sound judgment in prioritizing workflow
• Ability to establish sound working relationships with different types of people with differing levels of skill and background is essential.
• Detail & deadline oriented, well organized; demonstrated ability to clearly organize, plan and schedule tasks and communicate status of projects in a timely manner.

Date Posted: 2022-03-16Full-time
EndoGastric Solutions, Inc. is a fast-growth medical technology company headquartered in Redmond, Washington. The company is revolutionizing the fields of upper gastroenterology diseases including gastroesophageal reflux disease (GERD) and other GI disorders.

Reports to:  Sr. Director, Quality Assurance & Regulatory Affairs
Status: Regular, Exempt
Location: Redmond, WA

Job Summary: Quality Engineer with duties supporting supplier development, quality management and change management within the Quality Department.

Position Responsibilities:

• Create and manage Supplier Audit Schedule. Conduct Supplier Audits.
• Develop and maintain supplier qualification requirements.
• Own supplier changes and lead internal cross-functional efforts.
• Create supplier/component qualification plans and reports for new suppliers and supplier changes.
• Knowledge of sterilization process and sterilization validation.
• Review and approve component drawings and qualification plans.
• Create and/or review component failure mode and effect analysis (FMEA) working with cross-functional team.
• Handle Corrective and Preventive Action (CAPA) investigations.
• Develop, review, provide feedback and approve quality system documentation.
• Contribute to ongoing monthly quality review and quarterly Quality Management Review meetings.

Position Qualifications:

• BSME or equivalent experience in a medical device environment
• Five or more years relevant medical device industry experience
• Sound understanding of quality assurance concepts
• Full understanding of ISO 13485 and FDA 21CFR820
• Ability to lead quality and supplier interaction meetings
• Full understanding of part qualification processes
• ASQ Certification a plus (e.g. CQA, CQIA, CQT, CQPA, CQE, etc.)
• Strong communication, interpersonal and problem-solving skills with ability to work both independently and in a team environment and to present detailed technical data to internal personnel
• Effective oral/written communications skills with preferences in technical writing, presentations, reports, data analysis, etc.
• Experience with sterile disposable devices a plus

• Proficient in analyzing product data to perform statistical and trend reporting
• Proficiency with Quality tools/methodologies including: Design Control, Risk Analysis (Hazard Analysis), Design FMEA, Process FMEA, Statistical Analysis, DOE and MSA (Gauge R&R).

Reports to: Vice President, R&D & Operations
Location: Redmond, WA

Position Responsibilities:

• Conduct tests or research on the development of new designs, methods, materials, or processes under the direction of an Engineer
• Perform various laboratory tasks
• Perform research on prototype development, mechanical testing, and biological testing
• Perform design verification and product validation in compliance with FDA QSR requirements
• Organize and construct prototype products for laboratory testing including assembly, photography, video production/editing, data recording, and archiving
• Assist in the development of laboratory studies including test methods, fixtures, and sample construction/preparation
• Construct test fixtures
• Perform measurement and data collection tasks
• Organize laboratory data for further analysis
• Maintain records for experiments performed
• Other duties as assigned

Position Qualifications:

• Associates Degree or equivalent experience plus ten or more years’ experience in new product development with an emphasis in cardiovascular diagnostic or therapeutic devices.
• Hands-on research and development of medical products including arranging and performing all aspects of construction, documentation, problem solving and necessary testing.
• Knowledge of GMP, ISO and new FDA Design Controls.
• Expertise in production and prototype technologies including soldering, welding, braiding, centerless grinding and extrusion.
• Software literate such as AutoDesk-CAD, Excel, Word Perfect, Microsoft Project and Solidworks.
• Knowledge of equipment maintenance and calibration fundamentals.
• Good mechanical aptitude and dexterity.
• Knowledge of good laboratory practices.
• Understanding of custom prototype and equipment assembly.
• Works well in a dynamic and interdisciplinary environment.
• Good written and verbal communication skills required.

Equipment to be used in Performance of Job:

• Various power hand tools
• Various machine shop tools
• Test equipment including tension/compression testers
• Inspection tools

EndoGastric Solutions, Inc. is a fast-growth medical technology company headquartered in Redmond, Washington. The company is revolutionizing the fields of upper gastroenterology diseases including gastroesophageal reflux disease (GERD) and other GI disorders.