Provide key strategic significance to the company in the areas of R&D product launches, value improvement programs, product improvements and product transfers between facilities. Facilitate 24-hour support of existing manufacturing operations. Provide interface between R&D and manufacturing for the introduction of new products into manufacturing. Oversee creation, monitoring and control of project schedules and budgets such that company objectives are met. Manage assigned Manufacturing and Industrial Engineering department employees in accomplishing these activities.
Essential Duties and Responsibilities
Apply knowledge and remain current in the following areas: materials, process and equipment development, procurement and optimization, injection molding, medical product and packaging design, design for manufacturing, design of experiments, product development process, design controls, device master record generation, process validations.
Consult or provide technical advice to manufacturing engineers on product and process problems.
Participate in cross-functional teams led by manufacturing or R&D engineers.
Identify, analyze and provide financial details for potential value improvement opportunities and product improvements.
Participate on cross-functional teams for value improvement projects, product transfers, new products, and manufacturing support projects.
Assure appropriate validations are conducted.
Conduct design reviews as required.
Project team selection and management.
Generate project schedule, cost and performance targets, and perform tracking and reporting so that overall objectives are met.
Creation and management of capital and expense budgets and resource plan.
Provide leadership and communication to all project team members and functional managers such that the project objectives are clear, responsibilities are understood and progress is tracked and reported.
Ensure all members are an integral and accountable part of the team.
Manufacturing Operations Support
Provide timely resolution of product, process and equipment problems in the form of creative short and long term solutions.
Provide technical support to manufacturing operations.
Assist in the transfer of technologies to the maintenance and technical staff.
Assist in achieving manufacturing objectives.
Monitor manufacturing variances so that problem solving and improvement opportunities are identified.
Stay current with and ensure appropriate QA/RA SOP's are followed on all projects, including: regulatory submissions, product development process, design controls, biocompatibility and bio safety testing, process and product validations, and CO system.
Conduct failure analysis on QRGA's
Provide timely responses to the Corrective Action/Preventive Action (CAPA) program.
Provide support as required to GMP, safety, ISO, FDA and internal audits.
May perform other duties as assigned
Manages in order to ensure compliance with all relevant regulatory/legal requirements
QUALITY SYSTEMS DUTIES AND RESPONSIBILITIES
Individual Contributor - Build Quality into all aspects of their work by maintaining compliance to all quality requirements