Senior Quality Engineer

Join us today and make a difference in people's lives!
 

LivaNova is a global medical technology company built on nearly five decades of experience and a relentless commitment to improving the lives of patients around the world. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems. The company is listed on the NASDAQ stock exchange under the ticker symbol “ LIVN .” LivaNova is headquartered in London (UK) with a presence in over 100 countries and a team of more than 3,000 employees worldwide.

LivaNova Cardiopulmonary:

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 Summary:

With high degree of autonomy, the Senior Quality Engineer will manage product lifecycle ensuring that New Product Development Initiative programs and Product Sustaining initiatives are managed in compliance with design control and risk management procedures as well as applicable regulations in order to ensure the products meet requirements in terms of safety, efficacy, quality and meeting customer needs.

Essential Job Functions:

He/she serves as a core team member on product development teams and sustaining teams by providing technical expertise, direction and authoring deliverables. As the core team member, he/she will be responsible for the compliance for design control, risk management, product verification and validation, human factor engineering, biocompatibility, and design transfer to production. 

As part of the new product development core team he/she will establish supplier qualifications and supplier process verification and validation. These responsibilities are conducted in compliance with the Quality Management System requirements and the regulations of the countries where the franchise will distribute and sell the products. Contribute to successful regulatory audits in the back room/front room activities and serving as a subject matter expert.

Knowledge, Skills and Abilities Required:

• More than 5 years experience working on project teams resulting in PMA and 510k submissions.

• Successfully demonstrates an in-depth or breadth of engineering skill(s). Technical education or experience in an area related to cardiopulmonary or perfusion devices.

• Understands and can give examples of quality leadership, change management, implementation of change, acceptance sampling, statistical process control, risk management, design for manufacturing.

• Must have proficiency with quality tools such as flowcharts, statistical data analysis, mathematical reasoning.

• Results oriented with capability to prioritize and plan activities with attention to understanding expectations of internal and external stakeholders Develop and maintain strong, positive business relationships with key internal customers such as R&D, Project Management Office (PMO), Clinical, Regulatory Affairs, Sales and Marketing, and Finance (as appropriate) to fulfill design development activities, support audits / inspections, and develop and implement quality plans that will ensure company compliance with regulatory requirements.

• Open and honest with communication both up and down the leadership chain.

• Project management skills including outlining activities to be done and setting timeframes and tracking to completion.

• Proficient in all MS products, experience in MS Project or other planning tools.

• ASQ Certified Quality Engineer or other ASQ Certifications is a plus.

• Knowledge of regulatory requirements (e.g., FDA, ISO) as required for the position.

• Strong written and spoken English

• Excellent communication and presentation skills.

• Must be willing to take on related duties as required in support of company and departmental objectives.

Education:

• Engineering degree, advanced engineering degree preferred

Experience:

• Minimum related work experience of 8-10 years in Class II/III medical device manufacturing.

Pay Transparency:

• A reasonable estimate of the annual base salary for this position is $75,000 - $125,000 + discretionary annual bonus. Pay ranges may vary by location.

Employee benefits include:

• 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

• Flexible Work Schedules

Our commitment to Diversity & Inclusion:

LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination.

Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.

Notice to third party agencies:

Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Beware of Job Scams:

Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for “See Open Jobs” on https://www.livanova.com/en-us/careers, and check that all recruitment emails come from an @livanova.com email address.