Join a dynamic, fast-paced environment in the medical device arena!
• Provide engineering leadership in the development of pilot and high-volume production equipment and processes in support of new medical devices and product line extensions.
• Provide oversight during the manufacturing transfer phase of new products from R&D to Manufacturing.
• Collaborate with R&D during the prototype development phase to ensure robust product and process outcomes.
• Lead Design for Manufacturability activities with emphasis on high speed automation and high cavity tooling for medical device disposables.
• Provide a project leadership role during the development and manufacturing transfer phases of new product introductions and product line extensions; May lead product line extension project teams.
• Develop requirements specifications for equipment and processes in support of manufacturing strategies.
• Manage engineering activities being completed by outside organizations (e.g. equipment suppliers, mold builders) through evaluation of proposed designs and processes and making associated recommendations for improvements.
• Lead process, tooling and equipment development efforts with an end goal of successfully completing design and development activities through factory acceptance testing in support of achieving commercialization objectives and timelines.
• Conduct meetings and Design Reviews in conjunction with assigned projects.
• Provide detailed project plans and updates as required.
• Prioritize and balance workload of multiple project assignments based on business and functional objectives.
• Ensure compliance to safety, quality management and validation procedures and policies.
• Bachelor’s Degree in Mechanical Engineering or related technical field
• Minimum of 5 years of relevant experience within medical device industry
• Problem solving track record
• Knowledge of DOE, pFMEA, GMP, 6 Sigma
• Knowledge of Statistical Software and Practices
• Knowledge of Materials and Related Processes
• Solid Works Proficiency a plus
Inquiries and resumes to: Kathy Provost at firstname.lastname@example.org OR 978/952-6425
For more information, please visit http://www.agilesearchinc.com/