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Manufacturing Engineer Shift B
hace 2 meses
Job Summary
Nevro is seeking a skilled Manufacturing Engineer to play a key role in ensuring the manufacturability and testability of product designs. This position will be responsible for ensuring that supply chain, manufacturing processes, tools, and equipment are in place and capable of delivering high-quality products.
Key Responsibilities
- Evaluate production equipment to support process improvements, capacity, and cycle time requirements.
- Lead the acquisition, installation, and qualification of production equipment and tooling, including writing IQ, OQ, and PQ documentation.
- Understand manufacturing and problem-solving concepts, such as Value Stream mapping, 5S, and DMAIC, to improve quality, labor efficiency, and throughput.
- Lead, participate, and propose suitability solutions for production and improve manufacturability.
- Manage and maintain MP (manufacturing procedure) through the change order process.
- Drive regular production meetings to monitor manufacturing line performance metrics and line health.
- Utilize tools such as Gage R&R, Cp, Cpk, and SPC to ensure capable processes and improve process and first pass yield and eliminate scrap.
- Work with Quality counterparts to address manufacturing nonconformances and customer complaints.
Requirements
- Bachelor's degree in Mechanical or Electrical Engineering. Advanced degree (M.S.) is preferred.
- A minimum of 3 years of experience within the Medical Device industry, preferably manufacturing and/or designing Active Implantable Medical Devices (AIMDs).
- Strong English oral and written communication.
- Knowledge of ISO 13485 and Current US Food and Drug Administration -Quality System Regulations.
Skills and Knowledge
- Strong project leadership skills, utilizing structured project management tools.
- Strong interpersonal and technical writing skills.
- Experience managing component suppliers.
- Prior experience with manufacturing transfers.
- Strong electro-mechanical design/manufacturing and analysis skills.
- Experience with Solidworks and Six Sigma Certification a plus.
- Good analytical and problem-solving skills.
- Requires the ability to travel approximately 20% of the time throughout the United States and internationally.
- Good problem-solving and decision-making skills.
- Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.
- Must be organized, detail-oriented, and adaptable.
