A Growing Medical Device company expanding the R&D group for a successful high-volume, disposable medical product line, has a new opening for a Senior Product Development Engineer. New and next generation product development projects are in the works. We have multiple openings ranging from a Senior Design Engineer position to Senior Product Development Engineer and Project Manager for Engineering. Openings are currently available and Do require Medical Device industry experience. The key skill set for these openings is designing medical device products with injection molding, mechanisms or small parts.

Job Description: The Senior Product Development Engineer will lead projects from concept through development and commercialization. Provide technical leadership regarding the design, testing, and use of the devices. Act as liaison between the Research and Development group, and Sales and Marketing, Manufacturing, Quality Assurance, Regulatory Affairs, Planning/Logistics, and Packaging.

Responsibilities Include: Assist in compiling customer requirements and product specifications Drives prototype build process Component and assembly tooling strategy development Assure produce-ability and manufacturability of assemblies and components Drive component supplier selection and development Complete component and assembly qualifications Develop and meet product target costs New product qualification process and launch Compile and organize and interpret technical data. Troubleshooting and defect analysis Drive manufacturing transfers Project Leadership Concept Development & Product Design Product Performance Verification Product Transfer from R&D to Manufacturing

Background Preferred: BS Mechanical Engineering or Biomedical Engineering or similar, MS Preferred Minimum 4 years Mechanical Products R&D Experience within medical devices Strong Understanding of Product Development Cycle Knowledge of Lean and/or Six Sigma Tools Knowledge of PRO-E or other 3-D CAD systems

Knowledge of quality and manufacturing experience Knowledge of GD&T, SPC, DFA/DFM, DFMEA Techniques Knowledge of MS Office & MS Project Manufacturing Experience Helpful.

Must demonstrate personal commitment to quality in work and work products
Must ensure that all work complies with company standard operating procedures
Excellent communication, presentation, technical writing, and leadership skills
Familiarity with quality, regulatory and clinical standards including medical device design control requirements (FDA QSR, ISO13485)