Medical Device Software QA Manager — FDA/IEC 62304 Lead
Zimmer Biomet
A global leader in medical devices is seeking a Software Testing Lead in Austin, Texas. This role includes managing software verification and release strategies according to US FDA regulations. The ideal candidate will have extensive experience in software testing, team leadership, and knowledge of compliance standards. Responsibilities further include collaborating with development teams, mentoring engineers, and participating in audits. The position requires a Bachelor’s degree and at least 5 years of relevant experience. Flexible working conditions are offered. #J-18808-Ljbffr Zimmer Biomet
- ...forward. As a global medical technology leader for... ...What You Can Expect Manage software testing teams for... ...strategy based on the USA FDA, European and Asia... ...Part 820 (QMSR) and IEC 62304 (Medical Device Software Lifecycle Processes... ...least 4+ years in a Lead or Managerial role...Medical deviceFlexible hours
- ...Automation Test Lead - System and Software Testing for Medical Device (Electrosurgical) Location: Austin,... ...aligning with standards (e.g., IEC 62304, ISO 13485, ISO 14971, FDA 21 CFR Part 820). ~ Lead... ...with Git and test management tools (e.g., JIRA, ALM)....Medical device
$114.1k - $268.18k
...opportunities, a world-class training facility, and leading market tools, we help our people continue... ..., MAST Application Penetration Testing Manager to join our Managed Services practice.... ...Rewards package includes a variety of medical and dental plans, vision coverage,...SuggestedH1bLocal area- A leading pharmaceutical manufacturing company is seeking a Regulatory Affairs Specialist... ...ensuring regulatory compliance in the medical device sector, particularly for respiratory devices... ...strong understanding of ISO standards, FDA regulations, and CE marking. #J-18808-...Medical device
$99.3k - $198.7k
Abbott is seeking a Principal Analyst in Austin, TX to manage and develop medical device contracting templates, interface with various departments, and lead negotiations on contracts. The ideal candidate should have a Bachelor's Degree and at least 8 years of experience...Medical device- OrganOx is looking for a Territory Manager in Austin, Texas. This role is focused on managing commercial business and requires strong sales skills within the medical device industry. The ideal candidate will have at least five years of relevant experience, the ability to...Medical device
$68k - $114k
A leading medical technology company in Austin seeks a Prototyping Lab Engineer & Manager to enhance lab operations and support innovative medical device development. The role focuses on designing lab spaces, managing inventory, and providing technical assistance for prototyping...Medical device- A leading medical device company in Austin, Texas is seeking a Software Testing Manager. This role involves managing software testing teams for both manual and automated testing, verifying compliance with FDA and international regulations, and mentoring engineers. Candidates...Medical device
$129.3k - $258.7k
...Laboratories is seeking a Group Marketing Manager in Austin, TX. The role involves... ...products through strategic marketing plans, leading staff development, and serving as a... ...years of experience in the healthcare or medical devices sector. The position offers a competitive...Medical device- KICO Knee Innovation Company Pty Limited is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategies for medical devices in Austin, Texas. This position demands expertise in regulatory submissions across the US, EU, and Australia, combined with 7-8...Medical device
- OriGen Biomedical in Austin, TX seeks a Cleanroom Line Lead to supervise assembly, testing, and packaging of medical devices. This role requires strong leadership skills, adherence to quality standards, and the ability to motivate a team in a cleanroom environment. Candidates...Medical device
- ...Senior Manager Application and Solution Architect - Medical & Healthcare (f/m/d) Job... ...System Architect to lead the definition... ...regulated medical devices and consumer... ...regulatory standards (IEC 60601, IEC 62304, ISO 13485 for... ...our hardware and software capabilities and...Medical deviceRemote workFlexible hours
- Renesas Electronics Corporation seeks a skilled System Architect in Austin, Texas, to lead the development of semiconductor-based systems for medical and healthcare applications. The ideal candidate will have a Master’s or Ph.D. in Engineering, 12+ years of relevant experience...Medical deviceFlexible hours
- ...C++ Dev Lead/Architect Location: Austin, TX (Onsite) Duration: 6+ Months... ...Ability to architect, design and implement – software from scratch, also knowledge of design patterns, preferably in Healthcare & medical software device domain. Strong experience in Linux /...Medical device
$68k - $114k
Latent AI in Austin, Texas, is looking for a Prototyping Lab Engineer & Manager to enhance lab operations supporting groundbreaking medical device innovations. Responsibilities include managing lab design, providing hands-on support in prototyping, and ensuring compliance...Medical deviceFlexible hours- Global medical device corporation is seeking a Professional Education Compliance Lead to be responsible for overseeing all compliance aspects of professional education programs... ..., training, and consulting activities Manage compliance for all U.S. physician engagements...Medical deviceWork experience placementWork at officeLocal area
- ...to meet heightened FDA, MDR, and ISO 1415... ...clinical context, manage patient safety... ...Qualifications · Medical degree (MD, DO, or... ...roles within medical device, digital health, or... ...regulated healthcare software sectors. ·... ...Proven track record leading cross-functional teams...Medical device
- ...nuclear‑energy systems. We are seeking a Lead Recruiter to build and run our... ...will design processes, partner with hiring managers across engineering, manufacturing, and corporate... ...such as nuclear, aerospace, robotics, medical devices, or semiconductors. Proven ability to stand...Medical device
- A leading technology organization is seeking an Automation Test Lead in Austin, TX, to oversee testing for medical devices, focusing on Electrosurgical technologies. The ideal candidate has over 7 years of experience in test automation, strong knowledge of Python, and...Medical device
- ...Lead Certified Sterile Process Technician We are looking for a Lead Certified Sterile... .... In this position, you will assist the Manager in supervising the efficient processing... ...Processes decontaminated medical devices as they are received, according to established...Medical deviceFull timeLocal areaShift workAfternoon shift
$87k - $178.1k
...will mitigate solution risks and issues and lead client meetings and events. You will... ...Key skills and abilities include project management, sales scoping, requirements gathering, client... ...Deep understanding of Electronic Medical Record workflow documentation. Strong...Contract workTemporary workLocal areaFlexible hours$125.92k - $173.14k
Overview Varian Medical Systems, a Siemens Healthineers company, is hiring... ...a Quality Control (QC) Testing Manager. In this role you will be responsible for leading on-site QC testing operations... ...process samples, and finished medical devices meet defined specifications...Medical device- ...Austin, Texas, is seeking a quality assurance (QA) engineer to support new product... ...involves ensuring compliance with ISO and FDA standards, conducting audits, and authoring... ...Proficiency in Solidworks and knowledge of quality management systems are essential. Opportunities for...Medical device
- ...as, but not limited to, the following: Lead the design, development and implementation... ...promote industry best practices May manage relationships with key vendors/partners.... ...market services for products from advanced medical devices, to highly engineered aviation systems,...Medical deviceFor contractorsWork at officeLocal areaFlexible hours
$125.92k - $173.14k
...your unique contributions.Varian Medical Systems, a Siemens Healthineers... ...a Quality Control (QC) Testing Manager. In this role you will be responsible for leading on-site QC testing operations supporting... ...samples, and finished medical devices meet defined specifications...Medical deviceTemporary workWork at officeLocal area- A global technology and consulting firm is seeking a highly experienced QA/Test Manager 2. Located in Austin, TX, you will oversee QA and testing activities, lead user acceptance testing strategies, and coordinate feedback with stakeholders. The role requires 7+ years...
- Trustwise seeks a Manufacturing Test Software Manager in Austin, Texas, to lead a team of engineers and handle the development of manufacturing test solutions for complex electromechanical systems. This role requires strong leadership skills, a deep understanding of manufacturing...Flexible hours
- A leading gaming technology firm is seeking a Manager of Software Quality Assurance in Austin. This hands-on leadership role involves overseeing QA processes, managing a team of QA Analysts and Engineers, and ensuring alignment with enterprise standards. The ideal candidate...
- ...with significant unmet medical need, including presbyopia... ...atrophy. Our lead investigational asset,... ...presbyopia and received FDA approval on January 28,... ...pharmaceutical, biotech, or medical device environments, with... ...Medical Affairs, KOL Management, Thought Leader Engagement...Medical deviceFull timeTemporary workWork at officeLocal areaImmediate startRemote workFlexible hoursShift work
- ...mission forward. As a global medical technology leader for nearly... ...surgical precision. As a Software Developer you will be responsible... ...deploy software for medical devices in a production environment... ...Development with Qt Experience with IEC 62304 software development cycle...Medical deviceFlexible hours
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