Sr Software Design Quality Engineer

ents First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

This Software Design Quality Engineer position is responsible for various Design Quality Engineering functions in support of product development on Software within a Medical Device, specifically the Automated Impella Controller and next generation iterations. This is to include activities such as leading Risk Management activities, collaborating with development teams throughout the Software Development Life Cycle, guiding teams through Design Controls, and ensuring compliance to the Quality Management System.

Primary Duties and Responsibilities:
The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position:
• Drive quality focused design and development of software within the software development lifecycle (Agile/waterfall/SAFe/DevOps) by defining the requirements, design, verification and validation plan and strategies while maintaining traceability
• Lead and conduct risk management activities including system risk analysis and software FMEA's
• Ensure that Design controls are compliant with IEC 62304.
• Ensure that FDA and other regulatory knowledge and experience is applied to risk management, software development, and testing
• Participate in design reviews for the system as well as review and approve design input/design output artifacts including requirements, design documents, code review, test results, verification and validation.
• Review and approve Change Requests as needed to release software revisions to production/field
• Act as an effective team member in the execution of Quality functions in compliance with FDA QSRs (Design Control, CAPA, etc), ISO 13485, ISO 14971, IEC 62304, MDR, and other national and international quality and regulatory requirements and standard
• Contribute to the design, development and implementation of product assurance plans providing feedback to corrective and preventative actions to engineering, manufacturing, service and field operations and supplier performance
• Partner with Manufacturing, Engineering, and IT to ensure that computerized quality systems are compliant with Abiomed procedures, FDA Quality System Regulations, 21 CFR Part 11.
• Build and maintain strong interpersonal relationships within and outside of the company

Qualifications

• Bachelor's degree in engineering or Sciences is required
• 5+ years of quality experience
• Experience in the medical device industry as well as Medical Device Software systems. Knowledge of IEC 62304 required.
• Must possess an understanding of software development life cycle processes (waterfall/agile/DevOps) as applied within the regulated medical device industry
• Demonstrates strong knowledge of software quality engineering policies, principles and best practices and FDA/ISO requirements
• Takes initiative and demonstrates leadership and teamwork in a collaborative cross-functional environment
• Experience with Software cloud products, Software as a Medical Device (SaMD), and/or Medical Device Data Systems (MDDS) desired, but not required.
• Familiarity with Jama and Atlassian suite of tools (Jira/Confluence) helpful, but not required

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.