Sr. Advance Process Development Engineer 

         
Job Description:
Design and develop innovative medical devices with a focus on product and process reliability

Responsibilities:
·         Comply with the quality system requirements as well as any applicable regulatory requirements.

·         Work with engineers, technicians, machinists, and designers to coordinate and complete assigned tasks and projects including but not limited to Design for Manufacturing, process development and transfer to manufacturing, fixture and equipment design, process validation, specification development, documentation, and project timelines.

·         Develop standards in test methods and test specifications for product development.  Conduct testing utilizing DOE methodology and/or other experimental design tools.  Generate clear, effective testing reports.

·         Employ tools to ensure and improve reliability of both design and process such as DOE, Gage R&R, process capability, run charts, process validation, etc.  Must have a strong, practical knowledge of statistics and their application with various process development and improvement activities.

·         Frequently and effectively communicate task/project status and issues to supervisor and others as appropriate with recommendations for improvement or correction.

·         Complete projects in an aggressive manner consistent with corporate objectives.  Independently determine day-to-day tasks.

·         Supervise assigned engineers, technicians, assemblers and temporary workers.

·         Contribute to the intellectual property position of the company via invention and patent applications.  Maintain accurate documentation of concepts, designs, drawings and processes.

·         Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related the products.

·         Provide engineering and technical support of products introduced into both the domestic and international markets as well as physician in-service programs.

·         Procure and oversee outside vendors and consultants as required.

·         Work in compliance with quality systems, including design control and document control, in coordination with the Quality Assurance and Clinical functions.  Provide support in the resolution of product complaints and/or safety issues.

·         Work with the Manufacturing, Clinical Affairs, Sales and Marketing, and Quality Assurance functions to coordinate pilot production of new products and manufacturing transfer.

·         Support company goals and objectives, policies and procedures.

·         Maintain a professional, credible image with co-workers, vendors and consultants.

·         Perform other duties as assigned.
 
Education and/or Experience:      
§    BSME or equivalent preferred
§    With a BSME, five years of experience is required. With an MS, three years of experience is required. Experience in the medical device industry is also required.