Senior Quality Engineer

LivaNova; United States; Remote; USD 110,000 - 140,000; Full time

Job summary

LivaNova seeks a Quality Engineer in Houston, TX to support the lifecycle of electrical medical devices. The role involves performing design assurance activities, managing investigations, and ensuring compliance with regulatory standards. Candidates should have a BS in Electrical Engineering and 8-10 years of industry experience.

Benefits

Health benefits – Medical, Dental, Vision

Retirement & Savings Plan (401K)

Employee Stock Purchase Plan

Training & Education Assistance

Flexible Work Schedules

Qualifications

• 8-10 years of experience in medical/biotechnology industry.
• Demonstrable technical qualifications considered.
• Knowledge of QMS processes for medical devices required.

Responsibilities

• Perform design assurance activities for new product development.
• Lead investigations for manufacturing nonconformities.
• Ensure compliance with regulatory requirements throughout product lifecycle.

Skills

Electrical design

Statistics

Medical device regulations

Education

BS in Electrical Engineering or similar degree plan

Job description

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. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems around the world.

Every role at our company plays a part in our success, and you can be a part of a passionate team of dedicated people who love the work they do.

The Quality Engineer is responsible for supporting electrical medical devices through their full life-cycle. This specific Quality Engineering position will primarily focus on product development for electrical medical devices, including implantable pulse generators and programmers. This role will be based in Houston.

Key Responsibilities

• Performing design assurance activities as part of new product development and process/product changes

• Leading investigations for technically complex and challenging manufacturing nonconformities and post-market failures to identify root cause/corrective actions in a timely and compliant manner.

• Investigating anomalies identified during the product development process.

• Providing value-added feedback in technical design reviews

• Leading risk management activities throughout the product life-cycle

• Ensuring that we are applying the right engineering approaches and methods that meet procedural and regulatory requirements for all phases of product development projects including design inputs, design transfer (process validation), design verification and validation, etc.

The Team

This person will be working in a cross-functional environment, with a multi-disciplinary team of engineers within the Quality Engineering Department. This role interacts on a daily basis with Manufacturing Engineering, R&D Engineering, and Project Management. This person will have a demonstrable impact on the patient experience by ensuring that the devices we design, develop, and manufacture are safe and effective.

Qualifications

• Education: BS in Electrical Engineering or similar degree plan.

• Experience: 8-10 years of experience, preferably in a medical or biotechnology industry involved in supporting electrical, mechanical, or firmware engineering activities such as those previously detailed above for electronic medical devices.

• Candidates who do not meet the above criteria for years of experience, but who can still demonstrate technical qualifications will still be considered.

• Required knowledge includes electrical/mechanical design, statistics, and medical device regulations including the QMS processes required to develop and manufacture medical devices.

Location

• This position will be located at our site in Houston, TX (Clear Lake).

Pay Transparency

• A reasonable estimate of the annual base salary for this position is $110,000 - $140,000 plus 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

• Home Office Days

• Onsite Gym

Valuing different backgrounds:

LivaNova values equality and 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.