Senior Device Engineer

Pay Rate: DoE

Job Summary: This position provides mechanical and electromechanical engineering for sustaining engineering support for existing medical products as well as new projects. Area Of Responsibility Provide support for existing products, product investigations, and analysis to determine root cause and appropriate resolution of product issues, and support customer requirements Prepare and maintain all necessary product documentation including product specifications, bills of material, hazard/risk analysis, test procedures, and associated validations and procedures and support of suppliers and contract manufacturers Perform and complete mechanical tests and or experiments to assure designs meet industry standards, safety margins, reliability goals and international electrical and emission standards as appropriate Participate in project teams and assist with project plan definition, estimation, scheduling, tracking, and reporting for related projects Ensure that all aspects of the quality system are a high priority in all activities (e.g., design and development activity, validation protocols, risk assessment, etc.) Develop specifications, packaging, labeling and all associated design control documents in accordance with project, industry and regulatory requirements Contribute to new and supplemental regulatory submissions Train and/or provide direction to technicians; may train manufacturing personnel and/or suppliers when required Contribute ideas or generate Intellectual Property submissions Other duties as assigned Performs all principle duties that affect the quality of products and services provided by the company within the guidelines of 21 CFR 210/211, 21 CFR 820, ISO 13485, the Canadian Medical Devices Regulation (CMDR), Medical Device Directive (MDD) and other applicable standards, laws and regulations wherever we do business. Work Conditions Office Lab Manufacturing area/clean room area Maintenance Shop Exposure to noise, hot and cold, outside elements, some radiation

Physical Requirements: Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, talk, hear, taste or smell Close, distance and peripheral vision; depth perception, ability to focus Ability to operate production equipment and hand tools Operate hand truck Operate computer/office equipment Wear proper lab gowning and safety shoes Lifting and moving of heavy boxes/equipment up to 70 lbs. Travel Estimate Up to 10% QualificationBS in Mechanical Engineering preferred; Associates in Mechanical Engineering or relevant experience will be considered 7 years of experience in the medical device and pharmaceutical industry required Ability to interpret and resolve technical and design issues required Familiar with QSR / GMP regulations Experience with Microsoft Office Tools and Solid Works required Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.