Job Description :
We are currently seeking a Manufacturing Engineer to serve as a valuable member of the new product development team for building pre-production and test devices, evaluating device costs, planning and executing process validations, identifying suppliers, and ensuring design for manufacturability of all products. This position will play a key role in planning production for products experiencing high growth rates under tight deadlines. Primary Responsibilities: Manufacturing Engineering • Actively seek out cost improvements including performing detailed cost analysis to demonstrate business rationale and compliance impact. • Work toward resolution of manufacturing issues (NCMR and CAPA support • Generate and maintain manufacturing instructions, production BOMs, travelers, inspection plans, labeling, and other product documents. • Conduct product flow evaluations and implement process improvements to maximize efficiencies in new and established manufacturing processes. • Transfer new products and product changes to production (pilot and full-scale Prepare estimates of time and cost for production qualification and production transfer projects. • Lead prototype and pilot production of new products, product changes, and enhancements. • Monitor and react to trends in key process parameters (i.e. yield, output, throughput, and capacity) to improve production results. Develop and maintain systems to monitor and report on the process parameters. • Assist with day to day operations including vendor identification, quoting, purchasing, receiving, inventory management, and supplier management. • Provide engineering and technical support to operations, engineering and quality teams. Process Development and Validation • Lead design and development of manufacturing processes for new products, product changes and enhancements, and related tooling and fixtures. • Plan and execute manufacturing process validation activities. • Utilize Lean Six Sigma (LSS) tools and concepts to assist in process improvements. New Product Development Support • Partner with Product Development staff to ensure that products under development are designed for manufacture. • Author and lead team review of Process Failure Modes and Effects Analyses (pFMEAs • Prepare estimates of time and cost for production qualification and production transfer projects. • Lead and participate in the design and development of manufacturing processes for new products, product changes and enhancements, and related tooling and fixtures • Utilize costed BOMs, timed pilot builds and scheduling to establish cost of goods sold (COGS • Generate manufacturing instructions, production BOMs, travelers and inspection plans. • Plan and lead prototype and pilot production of new products, design changes, and enhancements. Requirements for the Manufacturing Engineer: • Bachelor’s Degree in Manufacturing Engineering or related field. • Minimum 4-7 years of experience with FDA/GMP regulated medical device manufacturing. • Project management including planning, execution, and meeting time and budget constraints. • Understanding of medical device DHF, DMR, and DHR files management and documentation requirements. • Experience developing and executing IQ, OQ and PQ product and process validation activities • Problem solving and trouble shooting skills in manufacturing and test equipment. • Experience in packaging and sterilization processes (particularly Ethylene Oxide and Gamma) and validation preferred. • Must have a demonstrate understanding of statistics and DOE applications. • MS Office proficiency. Work Culture • Small office environment, electrical and mechanical prototyping labs • Ability to “get the job done” in a we-can-do environment, allowing for flexible hours, depending upon the project and/or customer needs • Periodic travel, such as supplier visits (can typically be planned) Why Join Our Team? • Entrepreneurial work environment • Competitive compensation and benefits • Employee Wellness Program • Flexible work/life balance



Regards,

Sara