Principal Manufacturing Engineer

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 environment, manufacturing processes and equipment of disposables, polymeric, testing and characterization methods, measurement systems;

• 15+ years of experience in Process development and/or Process Engineering/Manufacturing of Class II and/or Class III medical devices;

• Demonstrated experience in the selection and qualification of assembly equipment and automation, automated assembly methods, robotics, PLCs, automated inspection, fixture design, injection molding and plastic joining techniques, including ultrasonic/RF/laser welding and adhesive/solvent bonding;

• Lean Six Sigma experience and knowledge of statistical data analysis techniques is a plus.  Experience using Minitab or similar statistical evaluation software/tools preferred;

• Effective analytical and decision-making skills;

• Detail oriented with strong organizational skills;

• Ability to work in an international environment;

• Highly motivated to enhance products, techniques and consequently the life of the patients;

• Excellent communication skills in English; Italian language skills preferred;

• Degree in mechanical / mechatronic / biomedical / physics engineering;

• Good knowledge of Microsoft Office suite;

• Willingness to relocate to Mirandola, Italy

Every Organ Wasted is a Life Not Saved.