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Senior Manufacturing Engineer
Senior Manufacturing EngineerLivaNova • Arvada, CO, United States
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Senior Manufacturing Engineer

Senior Manufacturing Engineer

LivaNova • Arvada, CO, United States
8 days ago
Job type
  • Full-time
Job description

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.

New Product Development

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.

Project Leadership

Oversee sustaining engineering and new product development projects

Ensure alignment with strategic goals and timely execution

Mentorship & Team Development

Support skill development of junior engineers

Assist in performance evaluations and policy interpretation

Process Development

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

Cross-functional Collaboration

Communicate findings and solutions across teams and with external partners

Apply market and competitor insights into engineering decisions

Required Skills & Experience

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

Engineering leadership or supervision experience preferred

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

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.

Education & Qualifications

Bachelor's degree in Engineering (Mechanical or Biomechanical preferred)

Master's degree in Engineering preferred

8-10 years of engineering experience in the medical device industry

Prior leadership experience strongly preferred

Pay Transparency

A reasonable estimate of the annual base salary for this position is $105,000 - $120,000 plus discretionary annual bonus. Pay ranges may vary by location and are awarded based on experience.

Benefits

Health benefits - Medical, Dental, Vision

Personal and Vacation Time

Retirement & Savings Plan (401K)

Employee Stock Purchase Plan

Training & Education Assistance

Bonus Referral Program

Service Awards

Employee Recognition Program

Welcome to impact. Welcome to innovation. Welcome to your new life.

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Senior Manufacturing Engineer • Arvada, CO, United States

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