Clinical 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 Neuromodulation:

As pioneers of the VNS (Vagus Nerve Stimulation) Therapy system, LivaNova continues to advance medical device solutions for patients affected by Drug-Resistant Epilepsy (DRE) and Difficult-to-Treat Depression (DTD). There are 3 million people in the U.S. alone and one on three people with epilepsy are drug resistant. People with severe seizures have, on average, a shorter life expectancy and an increased risk of cognitive impairment particularly if the seizures developed in early childhood. VNS Therapy for DRE is delivered through a device that sends mild pulses to the vagus nerve at regular intervals throughout the day in an effort to prevent seizures.

The Clinical Engineer is responsible for the planning and execution of validation activities for product development in Neuromodulation, with a focus on Obstructive Sleep Apnea. Clinical Engineers establish user requirements, develop use scenarios and user personas, develop the validation strategy, analyze product risks, and manage the execution of both informal and formal design validation with a focus on usability engineering.

Primary Activities

• Support the product development team in the determination of testable system level user requirements for new products/features.

• Develop informal and formal usability validation plans for a new product/feature or design change.

• Maintain and communicate changes to cost, scope, or budget of responsible projects or responsibilities within a project.

• Conduct face to face interviews with product users, assess cognitive workflow adequacy, and analyze task execution of users (formative evaluations).

• Assess use-risk throughout the development cycle of a new product or feature as part of risk analysis and maintain usage risk documentation throughout the product life cycle.

• Work with technical writers to develop and validate instructions for use.

• Author protocols and arrange/execute formal usability validation with actual or representative users to demonstrate usage requirements are met and appropriate usage controls have been implemented.

• Author design validation reports

• Author Human Factors Engineering report at the conclusion of the project to summarize all aspects of usability engineering conducted throughout the development/validation cycle of the product to support submission to regulatory bodies.

• Research the feasibility of new products or new product indications including protocol development and support for pre-clinical pilot studies.

• Facilitate animal research for feasibility or GLP studies for development for evaluation of new products or enhancements to existing products as applicable.

• Manage relationships with external vendors and mentor junior clinical engineers.

• Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products.

• Ensure compliance with regulatory requirements.

• Performs other duties as required by supervisor to support company goals and objectives.

Location & Travel Requirements

• This position will be based at our location in the Houston, TX area.

• This position may require moderate business travel of 20% or more of the time.

Minimum Qualifications

• Bachelor's degree in engineering, preferably in biomedical, electrical, biomaterials, or computer science

• At least 5 years of experience with product development and usability engineering, preferably in neuromodulation

• At least 3 years of experience working with Class III medical devices or connected care products

• Expertise with usability engineering and risk management standards, guidance(s) and regulations (e.g., IEC 62366-1:2015 / A1:2020, ISO 14971:2019, ANSI/AAMI HE75:2009 (R2018), FDA 2016 Applying Human Factors and Usability Engineering to Medical Devices Guidance)

• Demonstrated experience applying risk management practices to the product development process

• Demonstrated experience with the planning, design and execution of validation studies, and completing the associated usability engineering documentation

• Demonstrated experience supporting technical reviews for regulatory submissions and quality investigations

Preferred Qualifications

• Knowledgeable in obstructive sleep apnea and current treatment options

• Experience working with product development in sleep medicine / therapy

• Experience working with external research organizations in preclinical or clinical research

• Experience conducting literature reviews

Pay Transparency

• A reasonable estimate of the annual base salary for this position is $110,000 - $130,000 + 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

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.