Davita Inc.
Software Design Assurance Quality Engineer
Davita Inc., Granite Heights, Wisconsin, United States
Join us today and make a difference in people's lives!
LivaNova is a global medical technology company with nearly five decades of experience committed to improving patients' lives worldwide. Our advanced technologies and breakthrough treatments offer meaningful solutions for patients, healthcare professionals, and healthcare systems. Listed on NASDAQ under the ticker "LIVN," LivaNova is headquartered in London, UK, with a presence in over 100 countries and more than 3,000 employees globally. LivaNova Neuromodulation: We provide medical devices to treat neurological conditions such as epilepsy, depression, and obstructive sleep apnea. As pioneers in neuromodulation, our implantable devices deliver mild electrical pulses to target nerves, addressing chronic conditions. Our products aim to improve the lives of patients and their families. Position Summary: This role actively participates in developing product and non-product (e.g., automated manufacturing test systems) software and firmware as a core team member. The focus will be on our obstructive sleep apnea neuromodulation therapy, a rapidly growing area for LivaNova. Job Functions: Serve as a core team member on software/firmware development teams, providing technical leadership and direction. Responsible for risk management, design control compliance, development of design requirements, architecture specifications, and verification/validation (including testing). Chair change control boards for project change requests and defect management. Provide technical feedback during code reviews. Lead investigations of complaints and defects related to software/firmware, root cause analysis, and corrective actions. Maintain and update risk management documentation throughout the product lifecycle. Lead post-market cybersecurity monitoring and analysis. Participate in validation of manufacturing software, ensuring compliance and proper change impact assessment. Manage supplier support during development to meet program needs. Ensure compliance with software/firmware development and validation procedures. Contribute to regulatory audits as a subject matter expert. Knowledge, Skills, and Abilities Required: Experience developing medical device software/firmware, proficiency in IEC 62304. Ability to build strong relationships with internal teams such as R&D, Clinical, Regulatory, and Operations. Understanding of device design, manufacturing, and clinical benefits. Continuous improvement of technical knowledge in software/firmware development and testing. Collaboration skills within Quality to achieve objectives. Strong leadership, communication, and planning skills. Knowledge of regulations like ISO 13485, 21 CFR Part 820. Education: BSc in Computer Engineering, Computer Science, Electrical Engineering, or related field; advanced degrees or certifications are a plus. Requirements: 8+ years of experience. Proven performance in previous roles. Accountability for Quality Engineering in projects. Ability to present requirements clearly during audits and inspections. Pay Transparency:
Estimated annual salary $115,000 - $130,000 + bonus. Ranges vary by location. Employee Benefits: Health (Medical, Dental, Vision), Personal and Vacation Time, 401K, Stock Purchase, Training & Education, Bonuses, Recognition, Flexible Schedules. Valuing Diversity: LivaNova is committed to equality and diversity, ensuring a fair and non-discriminatory recruitment process. Notice to Agencies: We do not accept unsolicited resumes without a signed agreement. Unsolicited submissions may be hired without obligation. Beware of Scams: Verify job postings and recruiters. We will never ask for fees or banking info during the hiring process.
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LivaNova is a global medical technology company with nearly five decades of experience committed to improving patients' lives worldwide. Our advanced technologies and breakthrough treatments offer meaningful solutions for patients, healthcare professionals, and healthcare systems. Listed on NASDAQ under the ticker "LIVN," LivaNova is headquartered in London, UK, with a presence in over 100 countries and more than 3,000 employees globally. LivaNova Neuromodulation: We provide medical devices to treat neurological conditions such as epilepsy, depression, and obstructive sleep apnea. As pioneers in neuromodulation, our implantable devices deliver mild electrical pulses to target nerves, addressing chronic conditions. Our products aim to improve the lives of patients and their families. Position Summary: This role actively participates in developing product and non-product (e.g., automated manufacturing test systems) software and firmware as a core team member. The focus will be on our obstructive sleep apnea neuromodulation therapy, a rapidly growing area for LivaNova. Job Functions: Serve as a core team member on software/firmware development teams, providing technical leadership and direction. Responsible for risk management, design control compliance, development of design requirements, architecture specifications, and verification/validation (including testing). Chair change control boards for project change requests and defect management. Provide technical feedback during code reviews. Lead investigations of complaints and defects related to software/firmware, root cause analysis, and corrective actions. Maintain and update risk management documentation throughout the product lifecycle. Lead post-market cybersecurity monitoring and analysis. Participate in validation of manufacturing software, ensuring compliance and proper change impact assessment. Manage supplier support during development to meet program needs. Ensure compliance with software/firmware development and validation procedures. Contribute to regulatory audits as a subject matter expert. Knowledge, Skills, and Abilities Required: Experience developing medical device software/firmware, proficiency in IEC 62304. Ability to build strong relationships with internal teams such as R&D, Clinical, Regulatory, and Operations. Understanding of device design, manufacturing, and clinical benefits. Continuous improvement of technical knowledge in software/firmware development and testing. Collaboration skills within Quality to achieve objectives. Strong leadership, communication, and planning skills. Knowledge of regulations like ISO 13485, 21 CFR Part 820. Education: BSc in Computer Engineering, Computer Science, Electrical Engineering, or related field; advanced degrees or certifications are a plus. Requirements: 8+ years of experience. Proven performance in previous roles. Accountability for Quality Engineering in projects. Ability to present requirements clearly during audits and inspections. Pay Transparency:
Estimated annual salary $115,000 - $130,000 + bonus. Ranges vary by location. Employee Benefits: Health (Medical, Dental, Vision), Personal and Vacation Time, 401K, Stock Purchase, Training & Education, Bonuses, Recognition, Flexible Schedules. Valuing Diversity: LivaNova is committed to equality and diversity, ensuring a fair and non-discriminatory recruitment process. Notice to Agencies: We do not accept unsolicited resumes without a signed agreement. Unsolicited submissions may be hired without obligation. Beware of Scams: Verify job postings and recruiters. We will never ask for fees or banking info during the hiring process.
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