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Mfg Engrs - Senior NPI Engineer

Job in Fremont, Alameda County, California, 94537, USA
Listing for: Viant Medical Inc.
Full Time position
Listed on 2026-07-25
Job specializations:
  • Engineering
    Manufacturing Engineer, Quality Engineering, Medical Device Industry, Product Engineer
Salary/Wage Range or Industry Benchmark: 120000 - 180000 USD Yearly USD 120000.00 180000.00 YEAR
Job Description & How to Apply Below

Posted Tuesday, July 21, 2026 at 7:00 AM

COMPANY OVERVIEW

Meraqi Medical
, now a part of Viant Medical, provides design, development, and manufacturing services to medical device companies in the bioelectronics, interventional and structural heart, and minimally invasive surgical spaces. Meraqi provides solutions from early brainstorming, conceptualizing and prototyping, to full design and development, as well as clinical and commercial manufacturing.

Viant Medical is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources.

For more information, visit  or follow us on Linked In.

POSITION SUMMARY

The Senior NPI Engineer is responsible for leading the transition of new medical devices from product development into manufacturing while ensuring product quality, regulatory compliance, manufacturability, and production readiness. This role serves as hands on technical lead for cross-functional product launches and collaborates with R&D, Manufacturing, Quality, Regulatory Affairs, Supply Chain, and Operations to successfully introduce new products and process improvements and satisfy customer needs, budgetary and schedule requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES
  • Follow Viant D&D’s policies and procedures.
  • Lead new product introductions from design transfer through commercial manufacturing.
  • Develop and execute manufacturing readiness plans for new product launches.
  • Develop and implement robust cost-effective manufacturing processes and improve product flow and product quality and safety performance for both sustained and new products.
  • Lead manufacturing equipment development and implementation.
  • Establish assembly time and yield targets, training needs and quality control.
  • Determine tooling, equipment, and fixture needs for the timely and cost-effective manufacture of medical devices.
  • Create and maintain manufacturing documentation including:
    • Manufacturing Instructions
    • Bills of Materials (BOM)
    • Routers
    • Device History Records (DHR)
    • Device Master Records (DMR)
    • Work Instructions
    • Process Flow Diagrams
  • Develop and execute:
    • MVP/IQ/OQ/PQ Process Validations
    • Equipment Qualifications
    • Test Method Validations (GR&R)
    • Statistical analysis, P-Value. Ppk, Cpk, transformation etc.
  • Identify and resolve manufacturing issues during pilot and production builds.
  • Perform root cause investigations using structured problem-solving methodologies (5 Why, Fishbone, DMAIC, etc.).
  • Lead Engineering Change Orders (ECOs) and implementation of design changes.
  • Collaborate with customers and suppliers during product transfer and component qualification.
  • Drive Design for Manufacturability (DFM) and Design for Assembly (DFA) improvements.
  • Mentor junior engineers and provide technical guidance during product launches.
  • Lead Engineering Change Orders (ECOs) and implementation of design changes.
  • Collaborate with cross-functional teams during development phase(s), and provides inputs and recommendations for design for manufacturability (DFM).
  • Work with R&D staff to ensure smooth transition of products into manufacturing while assuring manufacturability, achieving cost targets and conformance with regulatory and quality requirements.
  • Perform analysis for cost reduction, and quality and efficiency improvement.
  • Troubleshoot designs and processes when defects occur, lead investigation to determine root cause and implement effective containment and counter measures.
  • Communicate with customers regarding process improvements, process deviations and production changes.
  • Monitor KPI metrics, prepare trending reports or project dashboard (product quality, production rates, downtime, fulfillment, etc.)
  • Support in project planning and timeline development & management for design transfer.
  • Work with customers, suppliers and manufacturing staff…
Position Requirements
10+ Years work experience
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