Abiomed, a part of Johnson & Johnson MedTech is recruiting for a Principal Software Design Quality Engineer located in Danvers, MA
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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. This Principal Software Design Quality Engineer will have a focus on supporting the Software as a Medical Device (SaMD) projects at Abiomed. This includes cloud connected Medical Devices and Medical Device Data Systems (MDDS). The engineer is responsible for various design quality engineering functions in support of development such as risk management, requirements and test reviews, as well as other design controls activities on Medical Device software.
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:
* Lead Design Quality Engineering activities in support of Abiomed's Software Product Development and Software Life Cycle processes for MDDS, CDS, IoT, Multi-function devices, and SaMD. This includes design controls, quality planning, risk assessments/analysis/management, design reviews, test method development and validation, design and process verification and validation test plans and reports, post-market monitoring, investigations, follow-up and reporting
* Ensure that Design controls are compliant with IEC 62304 and IEC 82304-1.
* Support and ensure adherence to Abiomed's product security processes.
* 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 Engineering Change Orders (ECO) as needed
* Act as an effective team member in the execution of Quality functions in compliance with FDA QSRs (Design Control, CAPA, etc), ISO 13485, MDR, CMDR, CMDCAS 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
* Bachelor degree in Engineering or Sciences is required, Masters preferred
* 8+ years of quality experience required
* Minimum of 5 years experience in the medical device industry as well as Medical Device Software systems and cardiovascular devices highly preferred (Class III medical device experience strongly preferred)
* Demonstrates strong knowledge of quality engineering policies, principles and best practices and FDA/ISO requirements
* Familiarity with TIR45 and Agile methodologies preferred.
* Takes initiative and demonstrates leadership and teamwork
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.