Staff R&D/Product Development Engineer
TE Connectivity
Assembly
Principal Mechanical Engineer, Foot & Ankle
CONMED Corporation
full-time
Posted on:
Origin: • 🇺🇸 United States • Tennessee
Visit company websiteSalary
💰 $130,654 - $209,980 per year
Job Level
Lead
About the role
- Lead projects and meet all assigned project deadlines and deliverables for: transfer of new products, continuous improvement projects, cost savings initiatives, design changes, and sourcing efforts
- Collaborate with Marketing to design and implement existing product enhancements & design changes through the change control process
- Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with Quality Management System procedures
- Support product transfers and launches by generating PFMEAs, control plans, inspection procedures and support supplier quality to qualify and approve production parts
- Independently research, ideate, innovate, design, develop, acquire prototypes & refine solutions to complex clinical problems
- Execute design verification and validating activities by applying industry standards, test strategies and applicable regulations to ensure safety, efficacy and compliance
- Perform process verification & validation and qualify/re-qual. vendors, suppliers, components, items, parts, new & existing processes, etc., including travel to suppliers to complete assignments
- Lead & own creation and refinement of engineering documentation, such as the Design History file elements in accordance with the Quality Management System
- Engage with supplier to investigate and resolve any issues that arise during the manufacturing process to ensure safety, quality, delivery, and cost objectives are met and supply disruptions are minimized
- Perform complaint investigations, root-cause investigation, recommend and implement corrective action for product design issues to ensure continuity of supply
- Support capital planning and acquisition activity including specifying equipment, contract negotiation, Installation and validation
- Initiates and implements changes in methods, design or process where necessary
- Analyze, correct & mitigate complex product design issues using independent judgment. Perform other related functions as required by management
Requirements
- Bachelor’s degree in engineering, mechanical engineering, biomedical engineering or related discipline
- 12 years related experience in product development engineering with a bachelor’s degree; 8 years with a master’s degree
- Medical Device experience, with mechanical design in a highly regulated industry (preferably across a range of manufacturing methods including injection molding, screw machining, milling, welding, and sterilization and packaging)
- Proficient in Computer Aided Design (CAD), Solid modelling (SolidWorks preferred)
- Applied technical knowledge of manufacturing methods and materials used to manufacture surgical devices (e.g. injection molding, screw machining, milling, welding, and sterilization and packaging)
- Prior Orthopedics new product development, including implantables, plating systems & surgical instrumentation, and/or soft tissue, allograft & biologics solutions (Preferably within Foot & Ankle)
- Sound understanding of GD&T, Design for Manufacturing (DFM), related statistical tools and process validation/verification techniques
- Prior project management and/or project engineering
- Prior experience validating manufacturing processes through IQ/OQ/PQ
- Experience performing MSA
- Prior applications of statistical, lean, and six sigma methodologies
- Familiarity with PPAP
- Adept at performing DFMEA & PFMEA
- Strong interpersonal, verbal and written communication skills
- Strong organizational, problem-solving, and analytical skills
- Versatility, flexibility, and a willingness to work within constantly changing priorities
- Proficient on Microsoft Project, Excel, Word, PowerPoint
- Expected Travel 0-30%
