Process Development Engineer

Description

Responsible for solving technical issues for customers. This may be anything from new product designs to manufacturing/quality issues. He/she helps establish specifications to ensure products conform to performance and quality standards. He/she works directly with QA to define and implement inspection activities and to enforce requirements as specified by design specifications and regulatory agencies. An engineer is responsible for following the established GMP/ISO/MDD compliant quality system practices as requested by the customer.

RESPONSIBILITIES:

• Manage customer projects and communication between NPX Medical and customers.
• Manage project goals and expectations with customers.
• Design and develop products and processes in various fields for  customers.
• Provide project plans and reports as to project status.
• Evaluate and procure equipment necessary to manufacture products. Contact and communicate with outside vendors for parts and/or services that are required by customers but cannot be performed
• Specify materials and processes to ensure the continued performance and compliance of products.
• Coordinate and supervise product/project scale-up during all transitions from design to production.
• Define and develop inspection procedures and tests to ensure product specifications are met.
• Define and develop qualification plans for products based on performance specifications and design prints.
• Provide technical assistance for diagnosing manufacturing and quality problems.
• Conduct technical and statistical investigations concerning quality problems.
• Develops and documents test plan protocols, standard operating procedures, specifications and test procedures.
• Perform systems validation.
• Review quality system changes pertaining to Engineering and Supply Chain.
• Provide training to operators for engineering documentation, including but not limited to: procedures, forms and traceability control forms.

Requirements

• Four-year degree in a technical discipline, ideally in mechanical, manufacturing, or industrial quality engineering.
• At least three (3) years of experience in a technical or engineering role.
• Strong oral and written communication skills.