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.
Position Summary:
We are seeking a skilled and detail-oriented Quality Assurance Engineer to join our team. This role actively participates in the development of cloud data management systems that support our VNS Therapy and Obstructive Sleep Apnea products. The ideal candidate will have experience using Microsoft Azure for development of complex data storage and connected care network applications.
Job Functions:
Collaborate with cross-functional teams to understand requirements and deliver cloud-based applications and services on Microsoft Azure.
Lead cloud platform qualification efforts, ensuring performance, security, and software validation requirements are met.
Take ownership of creating and maintaining standard operating procedures (SOPs) for key business processes for managing enterprise software applications and user accounts
Collaborate with cross-functional teams, including developers, product managers, verification testers and regulatory affairs, to effectively identify and resolve quality issues.
Participate in design and code reviews, ensuring quality standards and best practices are consistently met.
Serves as a core team member on product development teams to provide technical leadership and direction. Responsible for the risk management file, compliance with design control regulations, development of design requirements, architecture specifications, and design verification/validation methodology.
Lead investigations of software defects identified during development, nonconformities reported by users, or changes driven by audit and CAPAs.
Support the post-market cybersecurity process by monitoring potential threats and initiating further review and analysis with security experts.
Ensure compliance with procedures for software upgrade and deployment of maintenance releases to the field. Responsibilities include the evaluating the completeness and accuracy of change impact assessments and verification and validation testing.
Ensure compliance with software development and non-product software validation procedures.
Stay up-to-date with the latest Azure technologies and best practices
Continuously improve QA processes and methodologies, leveraging industry best practices and innovative approaches.
Knowledge, Skills and Abilities Required:
Experience with mobile device management and deployment of software updates on networked devices.
Experience with mobile device management systems to deploy software versions and configurations specific for a variety of global geographies and regional regulatory requirements.
Experience with developing software or firmware in the medical device industry including demonstrated proficiency in meeting the requirements of IEC 62304.
Develop and maintain strong, positive business relationships with key internal customers such as R&D, Clinical, Regulatory Affairs, and Operations to fulfill design development activities, support audits / inspections, and develop and implement plans that will ensure company compliance with regulatory requirements.
Maintain and improve technical knowledge in software/firmware development and test to provide value added feedback for new product development, investigations, and product/process changes to ensure the safety and effectiveness of LivaNova devices.
Exhibit strong leadership skills showing ability to influence both peers and other team members.
Exhibit Excellent written and verbal communication skills.
Demonstrate an ability to prioritize and plan activities.
Possesses in depth knowledge of pertinent regulations (e.g. ISO 13485, 21 CFR Part 820, etc.) to assure the documentation of all company-wide functions meet these requirements and, when necessary, identify compliant, effective and efficient approaches to fulfilling such requirements.
Education:
Bachelor's Degree in Computer Engineering, Computer Science, or related field.
Microsoft Azure certifications are preferred (e.g., Azure Developer Associate, Azure Solutions Architect Expert).
Requirements:
8+ years of experience experience in quality assurance, design assurance, and SDLC within the Medical devices, MedTech or Life sciences domain
Track record of design and management of cloud data storage systems, or network managed enterprise software.
Proven experience designing, developing, and deploying applications on Microsoft Azure. Experience with data analytics and machine learning is valuable
Excellent problem-solving and communication skills.
Sustained record of performance during tenure in previous position.
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.
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