This employer uses E-Verify.This role is to provide engineering support for development and manufacture of disposable and capital medical devices design by Monteris Medical.Activities include direct production line support, investigations and problem solving, cost savings and operational control improvements, design transfer and production setup of new products.**Primary Organization Responsibilities**- Provide engineering expertise for direct production line support.- Support manufacturing activities such as operator training, non-conformance investigations, troubleshooting, improving processes, and resolving line down issues.- Support returned product and complaint investigations resolution through field knowledge, direct field clinical communication and troubleshooting assistance.- Assess capital returned product failure modes and supports product refurbishment processes.- Actively seeks out partnerships with manufacturing personnel to improve process flow and part manufacturability.- Develops, builds/acquires, validates, and maintains parts lifecycle, manufacturing processes, bills of material, equipment qualification, and tooling.- Assists in identification of requirements and methods of acquiring requirements with a focus on reliability and design for manufacture.- Plans, supports, and owns design transfer activities by developing manufacturing processes and validation plans, executing process risk assessments and associated process validations.- Write test protocols, execute testing, analyze data, and write engineering reports.- Identifies, improves, and validates test methods used in a production setting; supports development testing as needed.- Identifies, proposes, and executes continuous improvement projects.- Provides regular technical support to Operations, Supply Chain, Quality, and Service to ensure business success and productivity.- Represents engineering on cross-functional teams for manufacturing to improve current product and new product design.- Assists Supply Chain/Operations and Quality Engineering departments in the identification, sourcing, and procurement of materials and products.- Understands and follows internal quality system, FDA, and ISO requirements.- Performs other duties as directed or assigned.**Personal Qualifications and Experience****Education/Experience**- Bachelor's degree in engineering (Biomedical, Mechanical, Industrial, Electrical, or similar) or related field is required. Advanced technical degree preferred.- 2+ years' experience in medical device development, testing, quality, manufacturing, or other relevant discipline**Skills/Abilities**- Possesses engineering and analytical skills, including being detail oriented, inquisitive, and able to work with complex systems.- Possesses strong communication skills and the ability to coordinate cross-functionally with Engineering, Quality, Operations, Clinical and Marketing.- General understanding of FDA regulations surrounding the manufacture of medical devices, GMPs and process validations. Experience using Six Sigma and Lean Manufacturing tools is a plus.- Experience with statistical analysis tools such as Minitab.- Experience with electromechanical processes.- Possess strong organization, engineering, analytical and communication skills.- Be extremely comfortable with accountability and being challenged to improve both their organization and the company's performance against quality goals.
