NPI Engineer III

POSITION SUMMARY

The New Product Introduction (NPI) Engineer is responsible for providing technical, hands-on knowledge and support for all aspects of manufacturing transfer operations. Under the direction of the Director of Manufacturing, the NPI Engineer will become the SME for designated manufacturing transfer projects (bioelectronics or complex interventional catheters production) and will be responsible to ensure the manufacturing transfer operation remains in compliance with the Viant D & D Quality System, customer needs, budgetary requirements, schedule requirements, and the regulatory requirements, as well as interfacing with Quality and R&D to achieve project goals.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Follow Viant D&D's policies and procedures.

• Participate in team meetings to ensure adequate communication between members and develop positive, proactive working relationships with other staff

• 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 design transfer of new products to production including establishing 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.

• Develop manufacturing process instructions, inspection plans, lot history records, process flow diagrams and device master records.

• Lead creation of manufacturing process validation plans, validation protocols and reports, and implement manufacturing process validations and test method validations.

• 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.

• Work with suppliers to ensure parts/services are properly documented and meet specifications.

• Perform analysis for cost reduction, and quality and efficiency improvement.

• Prepare document change orders and coordinates the implementation of changes including training production staff.

• 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.

• Develop and maintain statistical process controls, update control charts and reports.

• Monitor KPI metrics, prepare trending reports or project dashboard (product quality, production rates, downtime, fulfillment, etc.)

• Provide expertise in project planning and timeline development & management and maintain project schedules and timelines.

• 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.

• Effectively utilize lean manufacturing tools for continuously improve the flow of material and information at Viant D&D including assembly line layouts, visual management, 5S, JIT, Kanban's, etc. to increase manufacturing efficiencies, reduce takt time, improve floor space utilization, and minimize indirect support/overhead.

• Responsible for establishing and developing cross-functional teams to support NPI process and may identify optimal opportunities for product.

• Organizes interdepartmental activities ensuring completion of the project on schedule and within budget constraints in order to deliver the business solution to the customer.

• Maintains detailed documentation throughout NPI transition to commercial manufacture, and transfer to ultimate manufacturer.

• Prepares during the proposal phase and maintains during the program, project plans that specify project phases, tasks, task interdependencies, durations, resource assignments, and costs and risks plus containments/mitigations.

• Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.

• Ensures all work satisfies the requirements of the company's Quality Manual.

• Provide Operations design input to Product Development team.

• Perform other responsibilities duties as assigned.

• 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.

• 3+ 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.

• Depth of knowledge in one or more clinical, product or technical areas.

• Experience in contract manufacturing and/or manufacturing environment

• Experience in medical device manufacturing with preference given to prior bioelectronics or interventional catheter product production experience.

• 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.)