Sr Manager, Manufacturing Engineering

Job Description

Primary Function of the Position

Contribute your technical manufacturing, leadership, and project management skills to a dynamic manufacturing engineering team creating precision instruments for minimally invasive robotic surgery. This key technical management role will guide and mentor a talented engineering team responsible for supporting instruments product launches by designing manufacturing lines and equipment, improving manufacturing processes, creating and maintaining all associated manufacturing documentation, dispositioning discrepant material, and maintaining compliance with our quality system.

Essential Job Duties

Lead a team of Product Manufacturing Engineers, in collaboration with other organizations, to support

production of complex products with responsibilities including but not limited to:

• Provide strategic and technical leadership to the Manufacturing Engineering organization.
• Ensure the professional development of individual team members.
• Establish group and individual objectives, priorities, and metrics.
• Manage and allocate team resources over multiple projects. Provide and solicit resources to and from other teams as necessary.
• Lead the Manufacturing Engineering team to launch mid-volume MP instruments products.
• Ensure fulfillment of product development goals.
• Create, maintain, and improve “mid-volume” manufacturing assembly lines, specifying and/or refining BOMs, workflow processes, manufacturing plan, and detailed work instructions.
• Analyze instrument-manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.
• Specify, design, document, build and qualify the equipment necessary to perform each process step, while providing necessary manufacturing capacity.
• Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ).
• Analyze the data from current Manufacturing Operations to review trends, opportunities for improvement and implement changes on a continuous basis
  • Ensure reliability and efficiency improvements of existing products
  • Provide technical support for failure analysis and root cause investigation of product failures.

• Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation.

• Work with Quality Engineering group to ensure that the team follows appropriate GMP, design history file (DHF), and device history record (DHR) guidelines per FDA requirements, and support design reviews in accordance with product development procedures.