Staff Manufacturing Engineer - Orthopaedic

The successful candidate will work within a cross-functional project team through all phases of the product development process, planning and executing projects through product launch, working closely with R&D, Quality Engineering, Marketing, Finance, Sourcing, Plan, and External Manufacturers to define user needs, generate design concepts and prototypes, perform design evaluations (tolerance analysis, FEA, DOEs, simulated use testing), and support development of product and process validation plans and testing.

Responsibilities

• Collaborate with R&D, Quality engineers and External Manufacturers in developing new product designs within a cross-functional team environment, developing innovative manufacturing solutions for soft tissue and shoulder reconstruction implantable devices
• Establish the relationship between product design features and the selected methods required to manufacture the product
• Provide detailed assessments and critical Design for Manufacturing review of engineering designs/drawings of components and assemblies
• Participate in design reviews to assess design intent, manufacturability, proper dimensioning and tolerancing of components and assemblies to allow product to transition into the manufacturing environment
• Manage the manufacturing of prototypes used in new product development, including selecting the most appropriate prototype methods and executing prototype development to support new product design trials
• Complete financial estimates of components and assembly Cost of Goods Sold
• Provide analysis and recommendations for feature and manufacturing cost tradeoffs during the design phase of new products
• Develop comprehensive, cost effective manufacturing strategies, including supplier selection, to drive product team decisions on sourcing to achieve cost and time targets
• Provide technical support to external manufacturers in process development, characterization, validation and stabilization
• Support ERP and Quality System assessments and deliverables (Functional Impact Assessments, Routers, Drawing Reviews, Product Quality Plan, process related NPI Non-conformances)
• Mentor entry level engineers and oversee suppliers to optimize designs for manufacturability and assembly to produce functioning prototypes and supporting production documentation

Qualifications

• Bachelor's Degree in Engineering or related, required
• Minimum of 6 years of experience is required in a maintenance manufacturing environment
• Demonstrated experience in Project Management is preferred
• Proficiency with Microsoft Office: Word, Excel, PowerPoint
• Experience working at medical device industry or pharmaceutical preferred