Principal Manufacturing Engineer

Job description

Job Description: RESPONSIBILITIES This position is responsible for, but not limited to, the following: Responsible for the implementation and the optimization of robust manufacturing processes in Production ensuring that safety, effectiveness, quality and reliability of the devices are met. Lead PFMEA activities in coordination with other stakeholders. Generate and validate work instructions and test procedures. Specify, design, and install equipment, tooling and fixtures used in production. Participate in DFM and DFA activities to define manufacturing processes for new product and product improvement programs. Develop Critical to Assembly (CTA) requirements as required for manufacturing processes. Identify Key Performance Indicators and process capability metrics using Measurement System Analysis (MSA), Gage Repeatability and Reproducibility (GR&R), and Statistical Process Control (SPC) techniques. Perform other TransMedics tasks and duties as assigned/required. MANAGEMENT RESPONSIBILITIES: This position will not have management responsibilities. PHYSICAL ATTRIBUTES: Office environment: MINIMUM QUALIFICATIONS: Broad technical experience in FDA/ISO regulated biomedical device envir...