The Senior Engineer will be a part of a broad and diverse team responsible for the engineering and project management of orthopedic implant and instrument systems. The Senior Engineer will produce components of new product launches, targeted product renovations, and product related manufacturing optimization and executions, all in support of the Tyber Medical business objectives. The job will focus on new project development, maintenance of legacy products, and the customization of implants and instrumentation.
Areas of Responsibility
- Responsible for complete engineering ownership of activities on assigned projects; including component, assembly, and full system designs incorporating advanced and new technology features.
- Ensure all product development activities are conducted in accordance with Design Controls, the company’s Quality System ISO 13485, FDA QSR, and 93/42/EEC MDD, as well as additional customer design or quality control requirements.
- Responsible for the content of the Design History Files for all Tyber Medical projects which the engineer is assigned to.
- Author and review drawings, protocols, test reports, DHF documentation, and other documents as needed.
- Forecast, quote, and assist with the purchasing of the V & V parts and testing parts for product development and custom projects.
- Through leadership, help guide a multifunctional team through all phases of the projects and assist with post-market activities.
- Capable of performing mechanical and functional verification and validation testing following approved protocols.
- Provide guidance and support for project transfer into operations for launch.
Qualifications and Requirements
- Bachelor’s degree in Engineering, preferably Mechanical or Biomedical.
- Minimum 6-8 years of product design, engineering, project management, and manufacturing experience in the orthopedic/medical regulated industry.
- Proven experience in the design of plating, screws, and instrumentation, preferably in the trauma or extremity device space.
- 6 years minimum experience with Solidworks, preferably expert level. Must be able to surface and model complicated parts, assemblies, and drawings.
- 4 years minimum experience with drafting using GD&T.
- Experience running FEA analysis.
- Proven experience working with the FDA, creating DHFs, and CE Technical Files.
- Must have experience working in a ISO 13485 & 14971 regulated environment.
- A proven track record of participating in multiple, complex product development life cycles, including successful launches of new Medical Devices into commercial sales.
- Proven capability in developing and managing relationships with customers and suppliers.
- Experience with mechanical, biological, and surgeon simulation testing.
- Experience in technical writing.
If you’d like, you can email us your resume to keep on file at Careers@tybermed.com