Mfg Engrs - Senior NPI Engineer

Viant•Fremont, CA

About The Position

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.

Requirements

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.
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.)

Nice To Haves

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.

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).
Perform 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.
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.