Tech Lead

Position Summary and Overview
The primary role of the Quality Engineer is to provide Quality Engineering support for software development projects. This includes providing specific project deliverables, as well as, providing review and guidance for risk and product development management, verification, and validation activities related to the product lifecycle management. Highly focused on the design and development of software products and quality processes including Software as a Medical Device (SaaMD), Embedded software devices, and Interoperability devices using Agile methodology
Leica Biosystems is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.
ajor ResponsibilitiesParticipate in cross-functional teams at various phases of the development cycle as the Quality Engineering representative. Work independently and with project team members to develop design control deliverables including quality plans, design controls deliverables, test methods, and Design History Files.
Manage and developed Quality Engineer activities and deliverables for development lifecycle management.
Manage and develop Quality Engineer related activities and deliverables for software SaaMD, Embedded software, and non-medical software development lifecycle management in international cross-functional teams in accordance with 21 CFR 820, IEC 62304, IEC 82304, and other applicable regulation and standards.
Work closely with Regulatory Affairs on deliverables for global regulatory submissions, including FDA pre-submissions, 510k, and IVDR CE certifications.
Participate in the development and maintenance of product risk management, hazard analysis, and FMEAs for multiple projects in accordance with ISO 14971.Work independently and with project team members to develop and improve products and QMS procedures/processes to reduce variability and increase robustness throughout the development cycle for multiple projects.
Work with cross-functional teams to execute cybersecurity risk analysis for various products.
Work with cross-functional teams to establish and maintain Cybersecurity Risk Management and Quality Management System (QMS) framework based on applicable regulations, standards, and guidance.
Represent the LBS organization in various industry events conducted by regulators and Community organizations.
Execute other Quality Engineering related activities as specified by the RA/QA leadership.
Prepare regular performance reports for Quality Management Systems and project development. Maintain associated databases and design reports to reflect management input and changing organizational needs.
Meet company and departmental goals in the continuous improvement of all products, services and processes.
B.Tech/BS in Engineering or Computer Science related fields.
6+ years of experience in quality field in a medical device, IVD or similarly regulated industry
Experience with software and software/hardware development within a regulated industry including strong working knowledge of 62304,82304 SaaMD, 1497
Desired Skills/Experience List of valued, but not required skills and qualifications
Effective presentation/communication skills, project/resource management skills.
Ability to work independently and in a team environment.