Senior Manufacturing Quality Engineer

TransMedics•Andover, MA

About The Position

POSITION SUMMARY: TransMedics is looking for a Senior Manufacturing Quality Engineer that will develop, implement, and manage quality systems for manufacturing, focusing on process improvement, defect reduction, and compliance, involving root cause analysis (CAPA), audits, statistical process control (SPC), FMEAs, and training junior staff, while ensuring adherence to ISO/regulatory standards for high-quality, reliable products in a fast-paced, collaborative environment . RESPONSIBILITIES This position is responsible for, but not limited to, the following: Utilization of statistical data analysis for trending and investigation purposes Ability to communicate ideas and information clearly, effectively, and concisely Provide quality engineering support in the manufacturing of medical devices & hardware Ensure compliance of manufacturing processes and areas to all applicable quality system regulations Lead Nonconformance (NCMR) process such as inspection methods, containment, correction, closure and CAPAs, and drive continuous improvements through analysis of trend data Monitor and analyze production information to support risk management and to provide direction for corrective and preventive actions and/or process improvement activities Partner with manufacturing engineering to ensure necessary process controls and validations are in place and best practices are followed (GMP) Partner with Manufacturing Engineering to implement and maintain electronic manufacturing and inspection work instructions within a Manufacturing Execution System (MES) Oversee the inspection & testing of raw materials, components & finished products to ensure compliance with specifications & quality standards. Establish and maintain quality control procedures, including inspection methods and test protocols. Support internal and external auditing requirements in manufacturing to ensure compliance with quality system requirements Support other Quality Engineering functions as required (supplier quality, service, design QA) Perform other TransMedics task and duties as required MANAGEMENT RESPONSIBILITIES This position manages the following positions on a daily basis. This position will not have management responsibilities. PHYSICAL ATTRIBUTES Office and clean room environments Ability to lift up to 25 pounds MINIMUM QUALIFICATIONS Bachelor's Degree in Mechanical, Electrical, or Biomedical Engineering or other scientific or related discipline. Minimum of 8 years’ experience in a Manufacturing Quality and/or Manufacturing Engineering role Experience with work instruction development and maintenance within an MES environment PREFERRED QUALIFICATIONS Working knowledge of Medical Device Regulations: FDA 21 CFR 820, ISO 14971 & 13485 as well other applicable regulations and industry standards pertaining to Medical Devices. Experience with manufacturing of complex medical device products. Experience with medical capital equipment and electromechanical devices preferred. Experience with formal problem-solving methodologies and deductive skills, root cause analysis & CAPA. Experience with handling non-conforming material and assemblies. Practical knowledge and experience using Minitab or other statistical analysis tools. Understanding & application of Gage R&R and Measurement system analysis desired. Experience with process validation Experience with non-product software implementation and validation Familiarity with Manufacturing Execution Systems (MES) software Experience presenting data and information to management, including senior and/or executive management 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. www.TransMedics.com TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $118,600 - $148,000, which represents the company’s current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history.

Requirements

Bachelor's Degree in Mechanical, Electrical, or Biomedical Engineering or other scientific or related discipline.
Minimum of 8 years’ experience in a Manufacturing Quality and/or Manufacturing Engineering role
Experience with work instruction development and maintenance within an MES environment

Nice To Haves

Working knowledge of Medical Device Regulations: FDA 21 CFR 820, ISO 14971 & 13485 as well other applicable regulations and industry standards pertaining to Medical Devices.
Experience with manufacturing of complex medical device products.
Experience with medical capital equipment and electromechanical devices preferred.
Experience with formal problem-solving methodologies and deductive skills, root cause analysis & CAPA.
Experience with handling non-conforming material and assemblies.
Practical knowledge and experience using Minitab or other statistical analysis tools.
Understanding & application of Gage R&R and Measurement system analysis desired.
Experience with process validation
Experience with non-product software implementation and validation
Familiarity with Manufacturing Execution Systems (MES) software
Experience presenting data and information to management, including senior and/or executive management

Responsibilities

Utilization of statistical data analysis for trending and investigation purposes
Ability to communicate ideas and information clearly, effectively, and concisely
Provide quality engineering support in the manufacturing of medical devices & hardware
Ensure compliance of manufacturing processes and areas to all applicable quality system regulations
Lead Nonconformance (NCMR) process such as inspection methods, containment, correction, closure and CAPAs, and drive continuous improvements through analysis of trend data
Monitor and analyze production information to support risk management and to provide direction for corrective and preventive actions and/or process improvement activities
Partner with manufacturing engineering to ensure necessary process controls and validations are in place and best practices are followed (GMP)
Partner with Manufacturing Engineering to implement and maintain electronic manufacturing and inspection work instructions within a Manufacturing Execution System (MES)
Oversee the inspection & testing of raw materials, components & finished products to ensure compliance with specifications & quality standards.
Establish and maintain quality control procedures, including inspection methods and test protocols.
Support internal and external auditing requirements in manufacturing to ensure compliance with quality system requirements
Support other Quality Engineering functions as required (supplier quality, service, design QA)
Perform other TransMedics task and duties as required