Apply advanced scientific knowledge, engineering knowledge, mathematics and ingenuity to complete complex assignments with little or no supervision;
Optimizes the manufacturing processes of suppliers to provide sustainable gains in cost effectiveness and quality improvement through capital projects, statistical analysis, design of experiments, and procedural changes.
Works with suppliers and new product teams to develop launch and ramp up process capabilities.
Startup new products and equipment at suppliers: manages installation qualification, operation qualification, and process qualification.
Ensures new products meet requirements.
Evaluates suppliers’ processes in order to determine critical quality parameters and develops appropriate assembly and test plans at the supplier.
Ensures early supplier involvement in design reviews with engineering.
Develop and manage project and equipment schedules and corresponding budgets.
Works with Supply Base Managers to develop contingency plans with key suppliers.
Independently develops processes at suppliers.
Identifies the requirements necessary at the supplier to start production and to ramp up to higher volumes.
Works with suppliers to develop manual and automated processes and take them through validation
BS/MS in Engineering discipline.
Solid understanding of cGMP, FDA, and ISO standards, guidelines, and regulatory requirements. 5 years’ experience. Medical device manufacturing preferred. Strong process and equipment development experience desired. Thorough understanding of installation, operation, and process qualifications. Self- motivated individual with experience working in a team format. Ability to read, write, and understand English. Proven ability to manage multiple projects at once.