Employment Opportunities

Sr. Manufacturing Engineer

Manufacturing Engineer II

Quality Assurance Inspector

Senior Quality Engineer

Marketing Associate

Regulatory Affairs Manager

 

To inquire about any of the positions listed above, please send and email to our Human Resources Department at hr@evalveinc.com.

Sr. Manufacturing Engineer
The Sr. Manufacturing Engineer designs and develops manufacturing processes, tooling and fixtures in order to meet daily production schedules, while enhancing productivity and product quality.  Designs and develops manufacturing processes for new products, product changes and enhancements and related tooling and fixtures which are consistent with a zero defect level as well as low product cost.  BSME, MSME preferred.  BS and 8- 12 years of experience, or MS and 6-10 years of medical device experience.
Return to top.

Manufacturing Engineer II
Designs and develops manufacturing processes, tooling and fixtures in order to meet daily production schedules while enhancing productivity and product quality. Create and maintain tool drawings and shop orders in coordination with the Quality Assurance and R & D functions. Position requires a BSME or MSME with 2 to 5 years of experience.
Return to top.

Quality Assurance Inspector
Perform inspections, checks, tests, and sampling procedures of incoming materials, parts and components used in the manufacture of medical devices. High School graduate equivalent required. AA in a technical field preferred. Minimum of 1 -2 years experience in manufacturing required.
Return to top.

Senior Quality Engineer
Position would implement, support, and sustain elements of the Evalve Quality System through product development, design control, technical support, procedure generation, risk management, and training. The Senior Quality Engineer serves as the key resource for ISO, EN, MDD, and QSR requirements, and provides statistical support to the organization. Position would perform statistical analysis, develop and conduct training programs, implement Document Changes Notices, and assist regulatory affairs department regarding FDA regulations. A Bachelor’s degree in engineering or life science is preferred, with experience of five years in medical device industry or related field.
Return to top.

Marketing Associate
Responsible for supporting and assisting marketing activities and relevant administrative needs. Will work with Sales and Marketing team to plan events and develop media communications through print, video, and internet. Responsibilities include assisting with the development of brochures, production and distribution of newsletters, company website maintenance, development of conference promotional materials and more. Will also work with Regulatory Affairs to obtain approvals for marketing materials. A BS/BA in marketing or communications preferred. Video and graphics development and editing experience a plus.
Return to top.

Regulatory Affairs Manager
Provide Regulatory support and guidance to project teams and regulatory staff. Responsible for managing regulatory process to ensure compliance with US and international regulations, including preparation of submissions. Will review, provide feedback, and approve design and manufacturing changes to ensure regulatory compliance with FDCA, MDD and all other standards. A Bachelor’s Degree in Science, Life Science, Engineering, or equivalent (MS preferred). Requires 4-6 years experience in Regulatory environment preparing US and EU medical device submissions.
Return to top.

Within the United States: Investigational Device. Limited by United States law to investigational use. Within Canada: Investigational Device. To Be Used by Qualified Investigators Only – Instrument de recherche. Réservé uniquement à l'usage de chercheurs compétents.

This product is available for commercial distribution in the EU.