Principal Manufacturing Engineer

Overview

Job Description: 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.

Responsibilities

• 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. TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes.

Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health.

Maximize your potential at TransMedics, Inc.

TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.