Senior Manufacturing Engineer

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