Sr Software Design Quality Engineer - Danvers, United States - Disability Solutions

Description

Abiomed, part of Johnson & Johnson MedTech, is currently recruiting for a Sr Software Design Quality Engineer to be based in Danvers, MA, onsite 3 days a week

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives.

Abiomed's "Patients 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
• 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