Manufacturing Engineer for Neuromodulation Systems
hace 1 mes
Position Overview
Nevro is in search of a dedicated Manufacturing Engineer who will be instrumental in enhancing the manufacturability and testability of our product designs. This role is essential in ensuring that our supply chain, manufacturing processes, tools, and equipment are optimized to deliver Class III implantable Neuromodulation systems for pain management.
Key Responsibilities
- Assess production equipment to facilitate process enhancements, capacity, and cycle time optimization.
- Oversee the acquisition, installation, and qualification of production equipment and tooling, including the preparation of IQ, OQ, and PQ documentation.
- Apply manufacturing and problem-solving methodologies such as Value Stream Mapping, 5S, and DMAIC to elevate quality, labor efficiency, and throughput.
- Lead and contribute to the development of suitable solutions for production challenges and enhance manufacturability.
- Manage and uphold manufacturing procedures through the change order process.
- Conduct regular production meetings to evaluate manufacturing line performance metrics and overall line health.
- Utilize tools such as Gage R&R, Cp, Cpk, and SPC to ensure process capability and enhance first pass yield while minimizing scrap.
- Collaborate with Quality counterparts to resolve manufacturing nonconformances and address customer complaints.
Qualifications
- Bachelor's degree in Mechanical or Electrical Engineering; a Master's degree is preferred.
- A minimum of 3 years of experience in the Medical Device sector, with a focus on manufacturing and/or designing Active Implantable Medical Devices (AIMDs).
- Proficient in English, both oral and written communication.
- Familiarity with ISO 13485 and current FDA Quality System Regulations.
Skills and Expertise
- Strong project leadership capabilities, employing structured project management methodologies.
- Excellent interpersonal and technical writing skills.
- Experience in managing component suppliers.
- Prior experience with manufacturing transfers.
- Solid electro-mechanical design, manufacturing, and analytical skills.
- Familiarity with Solidworks and Six Sigma Certification is advantageous.
- Strong analytical and problem-solving abilities.
- Willingness to travel approximately 20% of the time, both domestically and internationally.
- Ability to make sound decisions and solve problems effectively.
- Commitment to adhering to all EHS regulations and implementing measures to prevent injuries and environmental pollution.
- Must be organized, detail-oriented, and adaptable.
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