The Sr. Mechanical Development Engineer will support the mechanical design, development, documentation, verification, and transfer to manufacturing of products and processes required to produce an implantable Neurostimulator System. The individual will also provide support to manufacturing.
- Supports the design and documentation of component and assembly specifications for a neurostimulator system.
- Designs, procures and qualifies product assembly and component inspection tooling.
- Completes risk analysis activities including design and process FMECAs and FTA of designs and processes.
- Performs assembly tolerance analyses to ensure reliable fit of components.
- Researches, justifies and applies manufacturing technologies to projects.
- Applies DFM/DFX principles to component and assembly designs.
- Works closely with suppliers, operations and other development stakeholders to address DFX issues and drive resolutions.
- Identifies and develops suppliers to produce parts and assemblies that meet requirements.
- Develops and validates manufacturing processes to defined requirements. Process development includes analysis of process data for capability in meeting defined requirements. Documents validation protocols and reports. Designs, procures, installs and qualifies all necessary tools and equipment.
- Verifies designs against product and/or design requirements including execution of functional testing and design analyses.
- Support manufacturing including the investigation into root cause of manufacturing defects and/or failures and recommendation and implementation of appropriate corrective actions.
- Perform responsibilities in compliance with NeuroPace Quality system procedures.
- BS degree in mechanical, manufacturing or industrial engineering or similar field, and a minimum of 7 years relevant work experience; preferably in the medical device field.
- Knowledgeable in many of the following:
- Familiar with design of electro-mechanical systems.
- Familiar with typical metal and plastic manufacturing processes.
- Familiar with fabricating, joining and molding typical engineering thermoplastics.
- Familiar with small component assembly while working under a microscope.
- Familiar with metallurgy and metal joining processes, including laser and resistance welding.
- Experience in the medical device industry (3years minimum) and training in GMP and ISO 13485 design control procedures.
- Proficient with CAD design tools (Creo solid modeling preferred).
- Capable of performing hands on work in a laboratory including the assembly and evaluation of prototypes. Familiar with typical laboratory equipment and tools.
- Experienced in selecting and working with suppliers to develop custom assemblies.
- Individual must be a self-starter with good problem solving and analytical skills, capable of independent work.
- Demonstrate effective cooperation and collaboration with multidisciplinary project teams.
- Knowledgeable in DOE/SPC/DFM tools and methods.
- Proficient in office PC applications, including MS Word, Excel, PowerPoint and Project.