Document Control Training Specialist

TransMedics, Inc. • Andover, MA

5d

About The Position

POSITION SUMMARY: This is a dual role combining Document Control skills and the ability to create and enhance the training within Quality. The ideal candidate will conduct change impact assessments, develop and implement change management and training strategies, and provide coaching and support to departments and employees impacted by change initiatives. RESPONSIBILITIES This position is responsible for, but not limited to, the following: Support and conduct thorough assessments of change impacts, identifying key stakeholders and potential risks associated with change initiatives conducting impact analyses. Develop and maintain comprehensive change management plans that outline the strategies for communication, material dispositions, training and support. Collaborate with cross functional teams to ensure alignment on change objectives and foster a culture of adaptability. Act as a liaison between project teams and impacted stakeholders, addressing concerns and facilitating feedback loops. Monitor and report on the progress of change initiative, ensuring milestones are met. Support the operation and improvement of TMDX Training Program including creating / adding curriculum assignments in the training system, creating and distributing training reports, and partnering cross-functionally to provide first line training support. Act as SME for the electronic training management system, providing training / support for system users. Ensure training records are accurate and timely. Guarantee easy and efficient retrieval of training documentation internally and externally as well as archival of training documentation. Utilizing various instructional design techniques to create engaging training material. Perform other TransMedics tasks and duties as assigned/required. MANAGEMENT RESPONSIBILITIES This position manages the following positions on a daily basis. This position will not have management responsibilities PHYSICAL ATTRIBUTES NA MINIMUM QUALIFICATIONS High School Degree 3-5 years’ experience working in a regulated industry; 3+ years of experience in change management, project management, training, quality systems, or related field. PREFERRED QUALIFICATIONS Bachelor’s Degree Strong problem-solving skills with a proactive approach to challenges. Ability to work collaboratively in a team-oriented environment. Ability to multi-task and manage multiple projects. Proven mindset of proactive continuous improvement. Strong organizational skills. Commitment to compliance and ethical standards. Excellent interpersonal, verbal, and written communication skills. Ability to communicate effectively with all members of the company including delivering presentations/training. Fluent in Microsoft Office. Med Device preferred. 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 $76,950-$96,050, 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. Employee Benefit: Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA Dental Vision Healthcare Flexible Spending Account Dependent Care Flexible Spending Account Short Term Disability Long Term Disability 401K Plan Pet insurance Employee Stock Purchase Plan 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. Welcome to TransMedics Careers! Our Vision is to help save more patients' lives by becoming the trusted partner to transplant stakeholders worldwide and delivering the highest quality technology, service and clinical care. TransMedics Group, Inc. (TMDX) is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. We developed the Organ Care System, or the OCS™, to replace a decades-old standard of care that we believe is significantly limiting access to life-saving transplant therapy for hundreds of thousands of patients worldwide. Our innovative OCS technology replicates many aspects of the organ’s natural living and functioning environment outside of the human body. As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. In concert with our OCS technology platform and OCS Connect™ app, which enables TransMedics and transplant clinicians to efficiently track, coordinate & communicate resource logistics for donor organs procured and maintained on OCS™, TMDX launched its National OCS™ Program (NOP) in 2022: 16 regional hubs across the U.S. staffed by a dispersed workforce of experienced, on-staff OCS Perfusion Specialists & Cardiothoracic and Abdominal Donor Procurement Surgeons. These resources are mobilized on-demand via our own dedicated ground & aviation transportation logistics network, to retrieve and deliver allocated donor organs from anywhere in the U.S. – aiding U.S. Transplant Centers in bidding farewell to the time & distance limitations of cold storage & expand the pool of viable donor organs for their transplant recipients.

Requirements

• High School Degree
• 3-5 years’ experience working in a regulated industry
• 3+ years of experience in change management, project management, training, quality systems, or related field.

Nice To Haves

• Bachelor’s Degree
• Strong problem-solving skills with a proactive approach to challenges.
• Ability to work collaboratively in a team-oriented environment.
• Ability to multi-task and manage multiple projects.
• Proven mindset of proactive continuous improvement.
• Strong organizational skills.
• Commitment to compliance and ethical standards.
• Excellent interpersonal, verbal, and written communication skills.
• Ability to communicate effectively with all members of the company including delivering presentations/training.
• Fluent in Microsoft Office.
• Med Device preferred.

Responsibilities

• Support and conduct thorough assessments of change impacts, identifying key stakeholders and potential risks associated with change initiatives conducting impact analyses.
• Develop and maintain comprehensive change management plans that outline the strategies for communication, material dispositions, training and support.
• Collaborate with cross functional teams to ensure alignment on change objectives and foster a culture of adaptability.
• Act as a liaison between project teams and impacted stakeholders, addressing concerns and facilitating feedback loops.
• Monitor and report on the progress of change initiative, ensuring milestones are met.
• Support the operation and improvement of TMDX Training Program including creating / adding curriculum assignments in the training system, creating and distributing training reports, and partnering cross-functionally to provide first line training support.
• Act as SME for the electronic training management system, providing training / support for system users.
• Ensure training records are accurate and timely.
• Guarantee easy and efficient retrieval of training documentation internally and externally as well as archival of training documentation.
• Utilizing various instructional design techniques to create engaging training material.
• Perform other TransMedics tasks and duties as assigned/required.

Benefits

• Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
• Dental
• Vision
• Healthcare Flexible Spending Account
• Dependent Care Flexible Spending Account
• Short Term Disability
• Long Term Disability
• 401K Plan
• Pet insurance
• Employee Stock Purchase Plan

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 501-1,000 employees