Description:

As a NPI Operations Manager, you will be responsible for the readiness, execution, and fulfillment, in our manufacturing operations team. You will drive process improvements and work closely with NPI engineers, quality engineers, design teams, and supply chain partners to deliver both investigational and commercial products to market. As the operations leader for new product introductions, you will lead a team of materials and process technicians to ensure products are built and comply with Verily’s quality standards.

Responsibilities:

• Liaison between product design and prototype operations enabling build readiness and ensuring production and process controls to meet ISO 13485 compliance.
• Lead Verily’s study device deployments and in-house product development production by directly managing assembly operations, inventory, and medical device documentation for devices.
• Manage inventory, equipment, and process traceability through proto and production lifecycles (receiving, identification and traceability, kitting, assembly, fulfillment).
• Identify and document non-conformances through Material Review Board, receive and process product returns to maintain accurate inventory and issue tracking.
• Assess and monitor manufacturing KPIs through the use of statistical methods and Six Sigma techniques. Maintain accurate reporting of manufacturing process nonconformities and implement necessary corrective actions.

Minimum Qualifications:

• BS degree in Mechanical Engineering, Industrial Engineering, Supply Chain, or Operations with 7 years of work experience.
• Medical device manufacturing or regulated process Engineering experience, including knowledge of ISO 13485 requirements and working with QMS systems.
• Experience leading manufacturing operations activities, including working with a global supply chain and driving continuous improvements and closing out of manufacturing issues.
• Proficiency reviewing design drawings, inspection techniques, and semi-automated equipment using mechanical design tools.

Preferred Qualifications:

• Experience in design and fabrication of electrical and mechanical components and assemblies, including plastic fabrication techniques, PCBA electronics, and industry automation practices.
• Track record in managing process, parts, and configurations transitioning from proto to production through the full product lifecycle.
• Medical device product launch experience through FDA clearance with strong competence in requirements and documentation compilation.
• Excellent written and verbal communication skills, with experience leading cross-functional teams with product design engineers, quality engineers, and manufacturing teams.

The US base salary range for this full-time position is $165,000 - $262,000 bonus equity benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

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