Careers

Reports to: Regional Sales Manager

Field Position Currently Available:

• Based in the Seattle area covering the territory of WA, OR, ID, AK
• Based in the N. Florida area, Jacksonville or Orlando
• Based in the Raleigh Durham area covering the territory of The Research Triangle, Charleston, and Columbia
• Based in the Denver area covering CO, Northern NM, UT, East WY
• Based in TX Panhandle/OK
• Based in Wisconsin

Job Summary: Responsible for sales and physician-support of Company products within an assigned geographic region. Responsible for all aspects related to sales including but not limited to prospecting, qualifying leads, demonstrating devices, closing orders as well as building excellent customer relations with physicians and hospital personnel.

Job Responsibilities:

• Develop sales plan and strategies for territory activities using Salesforce.com (SFDC) and Sales Process.
• Ability to develop an implementation plan with existing accounts to market a program.
• Demonstrate product, procedure and clinical knowledge by complete understanding of Company product.
• Maintain close key customer contacts to continually determine customer needs.
• Conduct sales presentations.
• Actively market the Marketing Department initiatives.
• Represent the Company at trade shows, exhibitions, training courses, conferences and events.
• Recommend product enhancements/changes based upon market feedback and increased sales potential.
• Work with and assist in developing Sales Representatives as added to Sales organization.
• Public speaking presentations to a variety of audiences.
• Other projects and assignments as required.

Position Qualifications:

• Demonstrated knowledge of surgical procedures with five or more years of medical device sales experience and ability to support procedure.
• Experience in delivery of effective technical sales presentations to medical professionals.
• Solid, documented sales success.
• Full understanding of reimbursement policy and process.
• Demonstrated interpersonal and persuasive communication skills.
• High proficiency in PC software application (Word, Excel, PowerPoint).
• Ability and willingness to undertake extensive travel.
• 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.

Based in Redmond, WA, EndoGastric Solutions, Inc. (www.endogastricsolutions.com) is a medical device company focused on developing and commercializing innovative, evidence-based, incisionless surgical technology for the treatment of GERD.

We currently have an opportunity for a Quality Engineer (level depending upon experience) with responsibilities supporting supplier quality management (40% of time), quality system improvements (40% of time) and product quality (20% of time) and within the Quality Department for data trending and reporting for various tasks.

Job Responsibilities:

• Review component NCRs for supplier performance.
• Analyze supplier performance and provide supplier and component tracking metric results to management.
• Develop supplier qualification requirements and determine supplier status.
• Create supplier performance communication tools, e.g. supplier scorecards.
• Review and approve component & assembly drawings and Inspection Criteria Documents (ICD).
• Mentor, review and approve part/component qualification plans, protocols, and reports.
• Facilitate, participate and/or conduct Corrective and Preventive Action (CAPA) investigations and manufacturing process audits.
• Perform administrative tracking and facilitate closures of CAPA investigations, WIP process audits, internal audits and internal corrective action responses. Analyze and provide all tracking metric results to management.
• Review and approve manufacturing tooling drawings and manufacturing work instructions.
• Review and close manufacturing nonconformance reports.
• Mentor, review and approve manufacturing process validation plans, protocols and reports generated by manufacturing teams.
• Coordinate with supplier QE and Receiving Inspection personnel when manufacturing issues arise.
• Demonstrate use of Quality tools/methodologies including: Design Control, Risk Analysis (Hazard Analysis), Design FMEA, Process FMEA, Statistical Analysis, DOE and MSA (Gauge R&R).
• Support Design/Change Control requirements consistent with regulatory and EGS procedures
• Mentor, review and approve manufacturing process FMEAs developed by manufacturing teams.
• Mentor, review and approve in-process, and final acceptance activity requirements developed by engineering and/or manufacturing teams.
• Develop, review, provide feedback and approve quality system documentation
• Contribute significantly to ongoing quality reviews, including Quality Management Review.

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
• Software validation experience would be a plus
• 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