Sr Extrusion Engineer

Burlington, MA

This Cutting edge Medical Device manufacturer is in need of a key contributor to take the manufacturing process from New Product Introduction Engineering to Hi Volume . This employer is very well funded and well into the FDA approval cycle with Clinical trials well underway. They offer a dynamic team oriented work environment. The right candidate would be Bonus and Pre Stock Option eligible TBD. Reporting to the VP of Manufacturing, the NPI Engineer works in a cross functional team of capable and experienced engineers who are working to commercialize a novel therapeutic system that includes both disposable components and capital equipment. Working with our team, this position will provide engineering leadership and support in the development and commercialization of a complex medical device in a fast paced, dynamic and mission focused company. With skills and experience in process development and design transfer of single use disposable products, the NPI Engineer works closely with team members and stakeholders to develop scalable processes, and introduce superior, highly effective, and safe products to the market. The NPI Engineer brings a hands-on experience with current and developing technologies as well as process improvements for higher volume manufacturing of single use disposable catheter and other medical products. Primary Responsibilities Working closely with Development Engineering, provide guidance and recommend design changes to allow for use of semi-automated processes which allow for repeatable, 5-6 sigma quality of single use disposables Develop, implement, monitor, and optimize manufacturing processes and methods, in accordance with product specifications and quality standards. Through design control process, research and implement semi-automated and fully automated processing technologies where appropriate to assist with yield improvements and higher throughput in manufacturing, with an ultimate goal of greatly reducing or eliminating adhesive bonds Critical liaison between R&D and manufacturing engineering teams to ensure design for excellence/manufacturing best practices are implemented into product design as early in development as possible. Develop product test plans and perform production test according manufacturing process instructions. Primary owner of manufacturing builds during product development, including hands-on assembly. Collaborate with design engineers to establish the strategies and production processes ensuring all requirements are met for safety and performance. Develop successful vendor relationships, including design consultants and catheter manufacturers. Generate detailed documentation (drawings, schematics, MPIs, Travelers, BOMs, Routings) in support of manufacturing assembly. Ensure product quality through pFMEA risk assessment and implementation of effective process controls including SPC. Execute process qualifications through IQ, OQ and PQ’s. Assist in failure investigations and root cause analyses as they relate to production processes, parameters, and fixturing. Responsible for implementation of identified production and process improvements related to root cause investigations. Work closely with supply chain management, Incoming Inspection, and vendors to assure that purchased material meets specifications in preparation for Design Transfer. Troubleshoot machine failures at system and subsystem level, during prototype assembly and as part of pilots build leading up to Design Transfer. Perform all activities in compliance with applicable regulations, Companies policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training. Bring a “can do” spirit to work and deliver on other responsibilities as assigned. Education or Certification Requirements Bachelor’s in Mechanical, Biomedical, or similar engineering discipline. Professional Work Experience Minimum of 5 years direct experience as a Manufacturing/NPI/R&D Engineer in a relevant high volume manufacturing environment. Qualifications and Skills Demonstrated strong DFM knowledge including mistake-proofing, simplification, standardization, and testing. Experience with developing medical devices through commercialization; includes design for cost of goods and manufacturing. Experience with high volume catheter manufacturing. A preference for a candidate with experience in catheter based technology (extrusions, molding, braiding, novel bonding and assembly techniques such as thermal weldng). Experienced with data driven engineering methodology such as FMEA, reliability testing, GRR, DOE, V&V. Able to manage projects from initiation to production launch. Job Type: Full-time Pay: Up to $150,000.00 per year

Contact breception@reardonassociates.com for more details.

Engineering

Posted on Oct 27, 2021