Software Quality Engineer

Medical Device Engineer

About the role:

Develop and Document innovative Class III Devices on this R&D team delivering products that sustain and improve the lives of patients around the world. You will use your technical and collaboration skills alongside your passion for innovation and continuous improvement to drive growth through efficient and effective development of new products.

Your responsibilities include:

Leads the on-going sustaining and software update cadence for the global footprint of intravascular imaging systems.

Represents the software function with cross-functional project team members.

Works cross-functionally to coordinate, develop, and communicate project schedules and refine project scope.

Drives completion of software team deliverables based on regulations and Quality System requirements.

Participates in reviews of design, code and documentation.

Authors and maintains documentation of software development activities according to the Quality System.

Tracks software development effort by creating and maintaining records in the approved software version control system.

Investigates, researches, and selects software designs, operating systems, tools and practices.

Interacts with senior internal and external personnel on significant matters requiring coordination between organizations.

Continuously improves process and work methodologies by interfacing with peers/cross-functional groups and analyzing activities to improve workflow and work processes.

Provides leadership role on championing functional best practices.

Mentors other engineers in software engineering activities/methodologies and domain knowledge.

Investigates field complaints and recommends corrective actions

What we are looking for:

Tech Keys:

5+ years of experience in Medical Device Industry; Software Development, Quality or Design Assurance

Preferred Qualifications:

BSCS, BS in Biomedical or similar

Experiences with the following:

Designing and implementing software using C and WPF

Windows operating system configuration and management

Designing and implementing test software and test automation frameworks

Knowledge of IEC 62304

EEOC: We are committed to equal employment opportunity without consideration of race, color, religion, ethnicity, citizenship, political activity or affiliation, marital status, age, national origin, ancestry, disability, veteran status, sexual orientation, gender identity, gender expression, sex or gender, or any other basis protected by law.