Medical & Maxillofacial Devices Project Engineer

Job Description

Job Description

ORTHOTIN PROJECT ENGINEER JOB DESCRIPTION

• Model and detail implant and instrument designs utilizing Pro/Engineer design software.
• Utilize/Manage design controls and risk management tools.
• Interface with clinical advisors to gather input for design modifications and assessment of product risk.
• Develop prototypes for design verification and validation.
• Develop verification and validation protocols and technical reports.
• Actively participate on, and sometimes lead, cross-functional design teams to address design issues and maintain existing designs.
• Partner with GQO teams in relations to Process Validation, Inspection, Inspection Methodology and DFM.
• Utilize knowledge of the surgical procedure in order to develop innovative solutions to solve / satisfy customer needs.
• Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the ORTHOTIN new product development procedures.
• Ensure quality of process and product as defined in the appropriate operation and material specifications.
• Will assist in the selection of components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.
• Will analyze equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings.
• Complete capability studies for in process inspection and generates subsequent Inspection documentation.
• Conduct MSA studies for new products and new processes.
• Provide training for manufacturing team members.
• Ensure adherence to GMP and safety procedures.
• Design, document, and improve manufacturing processes and operations that control the safety and efficacy of finished devices.
• Conduct qualification, verification, and validation activities for the production of medical devices.
• Analyze, troubleshoot and resolve issues relating to the safety, efficacy, quality, cost, or delivery of components and finished devices.
• Complete engineering work and contribute to new product development teams and product support, typically including the following activities: technology development, test of materials or products, preparation of specifications, Six Sigma, process study, process improvements, and report preparation.
• Development and implementation of appropriate supporting documentation, SOPs and process work instructions compliant with current Good Manufacturing Practices (GMP)
• Design, procure, and fabricate tooling and fixtures.
• Participate in design control efforts related to risk analysis (FMEA) & design reviews.
• Strong communication and influencing skills with both internal and external agents.
• Capable of technical leadership, influencing and providing technical direction to Engineers, Interns, Technicians and operators as required.
• Capable of working as part of a multi-disciplined team in an aggressive, dynamic and results motivated environment
• Source component and service suppliers; assess supplier capability and effectiveness.
• Train, develop, and/or provide work direction to operators and technicians.
• Participate in the identification, implementation, and management of production goals.
• Participate on cross-functional project teams. Coordinate, manage, and document project work and progress, and recommend appropriate revisions.
• Design and coordinate engineering tests and experiments. Analyze data, draw conclusions, and summarize test results.
• Interfaces with product builders or extrusion technicians, production supervisors, and engineers in troubleshooting problems on the production floor.
• Coordinates with the appropriate suppliers and other external resources needed in developing and implementing process/product improvement plans.
• Participates in project planning and scheduling.
• Attends and contributes to product core team meetings.
• Ability to work well with others in a team setting.
• Ability to conduct complex statistical, geometric, and mathematical calculations.
• Ability to conduct responsibilities with minimal routine supervision.
• Ability to read, understand, create engineering drawings on common engineering software.
• Ability to work efficiently on common personal computer hardware and software.

About Orthotin
Founded in 2013, OrthoTiN LLC is dedicated to designing and marketing high demand devices and surgical products for the Orthopedic Industry. The principals of OrthoTiN have been active in the industry for almost 30 years, and their purpose is focused upon the development of high-performance, all-titanium, alloy-based implant systems that include pioneering advancement in the use of ceramic, thin-film implant coatings.

Company Description

About Orthotin\r\nFounded in 2013, OrthoTiN LLC is dedicated to designing and marketing high demand devices and surgical products for the Orthopedic Industry. The principals of OrthoTiN have been active in the industry for almost 30 years, and their purpose is focused upon the development of high-performance, all-titanium, alloy-based implant systems that include pioneering advancement in the use of ceramic, thin-film implant coatings.