Mfg Engrs - Senior NPI Engineer

Viant Medical; Fremont (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Viant Medical is seeking a Senior NPI Engineer to drive the transition of new medical devices from development to manufacturing, ensuring quality, regulatory compliance, and production readiness. You will serve as the hands-on technical lead for launches and collaborate with R&D, Manufacturing, Quality, Regulatory Affairs, and Supply Chain to meet cost, schedule, and performance goals.

The role requires leading design transfers, developing manufacturing readiness plans, and implementing robust,

Qualifications

• BS in Industrial/Mechanical Engineering or equivalent
• 5+ years in medical device Quality, Development, Manufacturing and/or Program Management and/or Project Leadership
• Experience on design transfers for neurovascular, cardiovascular, catheter-based, bioelectronics or minimally invasive medical devices preferred
• Familiarity with FDA QSR and ISO 13485 medical device regulations
• Strong communication and project leadership skills

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 safety.
• Lead manufacturing equipment development and implementation.
• Establish assembly time and yield targets and quality control.
• Create and maintain manufacturing documentation (BOMs, DMR, DHR, WIs).
• Drive MVP/IQ/OQ/PQ validations and equipment qualifications.
• Identify and resolve manufacturing issues during pilot and production builds.
• Lead ECOs and implement design changes.
• Collaborate with customers and suppliers during transfer and qualification.
• Mentor junior engineers and provide technical guidance.
• Monitor KPI metrics and prepare project dashboards.
• Ensure capacity planning and site planning inputs from development to production.

Skills

NPI Leadership

Cross-functional collaboration

Regulatory knowledge

Lean Six Sigma

Problem-solving

Education

BS in Industrial/Mechanical Engineering

Tools

MS Office

ERP systems

Doc Control systems

Job description

1.1 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 viantmedical.com or follow us on LinkedIn.

1.2 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.

1.3 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 to generate capacity/capability models and assessments used as an input to site planning.
• Implement and manage process improvement and cost reduction programs.
• Ensure capacity is appropriate for the manufacturing plan.
• Maintains detailed documentation throughout NPI transition to commercial manufacture, and transfer to ultimate manufacturer.
• Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
• Ensures all work satisfies customer requirements and company’s Quality Manual.
• Provide Operations design input to Product Development team.
• Perform other related responsibilities duties as assigned.

1.4 REPORTING STRUCTURE

Reports to Sr NPI Manager.

1.5 SUPERVISORY RESPONSIBILITY

N/A

1.6 REQUIRED EDUCATION, EXPERIENCE, SKILLS AND KNOWLEDGE

• BS in Industrial / Mechanical Engineering or equivalent engineering discipline
• Bachelor’s degree in engineering or equivalent experience; mechanical or manufacturing engineering preferred but not required.
• 5+ years of experience in medical device Quality, Development, Manufacturing and/or Program Management and/or Project Leadership required.
• Experience on design transfers for neurovascular, cardiovascular, catheter-based, bioelectronics or minimally invasive medical devices is preferred.
• Knowledge of Lean Manufacturing and Six Sigma methodologies is preferred.
• Experience transferring products between domestic and international manufacturing sites is preferred.
• Familiarity with automation and manufacturing equipment development is preferred.
• Demonstrated ability to successfully bring products from concept to commercial manufacture.
• Familiarity with FDA QSR and ISO 13485 medical device regulations.
• Ability to interact with client companies in a professional manner.
• Experience in contract manufacturing and/or manufacturing environment
• Experience with lean manufacturing techniques, value stream mapping, and continuous improvement methodologies
• Solid knowledge of GMP, 21 CFR 820 and ISO 13485 regulations
• Strong computer skills, including the MS Office, ERP and Doc Control systems
• Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral
• Must be able to prioritize, and manage multiple deliverables while working in a fast-pace environment
• Problem-solving skills and critical thinking; highly motivated, focused, self-starter
• Quality-driven customer service,
• Able to work individually and as part of a team.
• Knowledge of statistical techniques (DOE, Gauge R&R, SPC, etc.)

1.7 CORE COMPETENCIES

Communication Skills

All verbal and written communications are concise, technically accurate, timely, and professional.

Demonstrates strong verbal presentation and negotiation skills. Represents in a positive and professional manner.

Expresses ideas, recommendations and solutions clearly, logically and concisely in both written and verbal communications.

Demonstrates tact and diplomacy in communications.

Demonstrates active listening skills and ability to resolve discrepancies with customers

Management of Resources