Senior Manufacturing Engineer

LivaNova•Arvada, CO

41d•$105,000 - $120,000

About The Position

As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow-because at LivaNova, we don't just treat conditions - we aspire to alter the course of lives The Cardiopulmonary Business unit has a unique portfolio of leading cardiopulmonary products that are used to treat millions of patients worldwide. Through a complete range of cardiopulmonary equipment and disposables led by the worlds #1 heart lung machine, LivaNova has been offering customer centric integrated perfusion solutions for decades. We are taking the next step in our commitment to innovation and development of perfusion practice with the launch of the completely redesigned Essenz Perfusion system. The Essenz Perfusion System is built on a 50-year legacy of trusted partnerships with perfusionists. It is designed to meet evolving standards of safety and reliability to deliver lifesaving care to patients. Position Overview We are seeking a Senior Manufacturing Engineer to lead process optimization, operational efficiency, and continuous improvement initiatives in a fast-paced disposable medical device manufacturing environment. This role combines independent decision-making with collaborative problem-solving and includes mentoring junior engineers and leading cross-functional projects.

Requirements

Experience in Class II/III disposable medical device manufacturing
Strong analytical, writing, and organizational skills
Proficiency in CAD Modeling, process validation, BOM development, PFMEA, DFM, DOE
Familiarity with Design for Manufacturability, Six Sigma and production analysis tools
Strong communication and cross-functional collaboration skills
Knowledge of FDA and regulatory requirements preferred
Bachelor's degree in Engineering (Mechanical or Biomechanical preferred)
8-10 years of engineering experience in the medical device industry

Nice To Haves

Engineering leadership or supervision experience preferred
Exposure to cardiovascular, intravascular or pulmonary therapies is a plus
Experience with plastic injection molded parts, plastic bonding, and single use sterile barriers a plus
Preferred understanding of Make-or-Buy analysis, project management.
Master's degree in Engineering preferred
Prior leadership experience strongly preferred

Responsibilities

Lead Design Transfer activities including process flow, DFM, MPQP analysis, testing, and documentation
Manage manufacturing department deliverables for new device development including delegation of Design Transfer tasks, report out to and with the Core Development Team.
Manage responsible portions of cross-functional deliverables, budgets and action plans/ timelines.
Oversee sustaining engineering and new product development projects
Ensure alignment with strategic goals and timely execution
Support skill development of junior engineers
Assist in performance evaluations and policy interpretation
Design and implement end-to-end manufacturing processes
Conduct PFMEA, cost analysis, fixture design, and training programs
Analyze data and generate test reports
Work with external manufacturing partners to design and/or understand their processes
Communicate findings and solutions across teams and with external partners
Apply market and competitor insights into engineering decisions