CONMED Corporation
Principal Mechanical Engineer, Foot & Ankle
CONMED Corporation, Memphis, Tennessee, us, 37544
Job Overview
CONMED Corporation is seeking a Principal Mechanical Engineer, Foot & Ankle to join their team. This is a high-impact position that will allow the candidate to leverage their problem-solving, project management, and technical skills in a role designed to bridge the gaps between new product development introductions, purchased manufacturing supply base, and product engineering. Responsibilities
Lead projects and meet 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 and design changes through the change control process Provide engineering support for new product and process introductions, ensuring 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, and 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 and validation and qualify/re-qualify vendors, suppliers, components, items, parts, new and existing processes, etc. Lead and own creation and refinement of engineering documentation, such as Design History file elements in accordance with the Quality Management System Engage with suppliers 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 Initiate and implement changes in methods, design, or process where necessary Analyze, correct, and mitigate complex product design issues using independent judgment Requirements
Bachelor’s degree in engineering, mechanical engineering, biomedical engineering, or related discipline 12 years of 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) Preferred Requirements
Proficient in Computer Aided Design (CAD), Solid modeling (SolidWorks preferred) Applied technical knowledge of manufacturing methods and materials used to manufacture surgical devices Prior Orthopedics new product development, including implantables, plating systems, and surgical instrumentation, and/or soft tissue, allograft, and 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, with demonstrated ability to plan and coordinate overall project schedules Prior experience validating manufacturing processes through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Experience performing Measurement System Analysis (MSA) Prior applications of statistical, lean, and six sigma methodologies to improve designs and processes Familiarity with Production Part Approval Process (PPAP) Adept at performing both Design and Process Failure Modes and Effects Analysis (DFMEA & PFMEA) Strong interpersonal, verbal, and written communication skills Strong organizational, problem-solving, and analytical skills; able to manage priorities and workflow to meet deadlines Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm Proficient in basic computer programs: Microsoft Project, Excel, Word, PowerPoint Expected Travel: 0-30%. Memphis/Hybrid: Must be willing and available to travel to the Memphis, TN facility as required. CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply.
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CONMED Corporation is seeking a Principal Mechanical Engineer, Foot & Ankle to join their team. This is a high-impact position that will allow the candidate to leverage their problem-solving, project management, and technical skills in a role designed to bridge the gaps between new product development introductions, purchased manufacturing supply base, and product engineering. Responsibilities
Lead projects and meet 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 and design changes through the change control process Provide engineering support for new product and process introductions, ensuring 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, and 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 and validation and qualify/re-qualify vendors, suppliers, components, items, parts, new and existing processes, etc. Lead and own creation and refinement of engineering documentation, such as Design History file elements in accordance with the Quality Management System Engage with suppliers 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 Initiate and implement changes in methods, design, or process where necessary Analyze, correct, and mitigate complex product design issues using independent judgment Requirements
Bachelor’s degree in engineering, mechanical engineering, biomedical engineering, or related discipline 12 years of 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) Preferred Requirements
Proficient in Computer Aided Design (CAD), Solid modeling (SolidWorks preferred) Applied technical knowledge of manufacturing methods and materials used to manufacture surgical devices Prior Orthopedics new product development, including implantables, plating systems, and surgical instrumentation, and/or soft tissue, allograft, and 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, with demonstrated ability to plan and coordinate overall project schedules Prior experience validating manufacturing processes through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Experience performing Measurement System Analysis (MSA) Prior applications of statistical, lean, and six sigma methodologies to improve designs and processes Familiarity with Production Part Approval Process (PPAP) Adept at performing both Design and Process Failure Modes and Effects Analysis (DFMEA & PFMEA) Strong interpersonal, verbal, and written communication skills Strong organizational, problem-solving, and analytical skills; able to manage priorities and workflow to meet deadlines Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm Proficient in basic computer programs: Microsoft Project, Excel, Word, PowerPoint Expected Travel: 0-30%. Memphis/Hybrid: Must be willing and available to travel to the Memphis, TN facility as required. CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply.
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