Sr Design Quality Engineer

Abiomed, a part of Johnson & Johnson MedTech, is currently recruiting for a Sr. 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. Learn more at https://www.jnj.com/.

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 Senior Design Quality Engineer position is responsible for various Design Quality Engineering functions in support of product development such as risk management, design verification, design validation, design assurance activities, as well as manufacturing process development support, and statistical analysis. This role's emphasis will be in support of Abiomed's new PreCARDIA system's continued development through Early Feasibility Studies on its way to full commercialization.

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:

• Support Design Quality Engineering activities in support of Abiomed's Product Development and Life Cycle processes including design controls, quality planning, risk management assessments, design reviews, test method development and validation, design verification and validation test plans, protocols and reports

• Ensure that Design controls are compliant with all relevant regulations (FDA, ISO13485, EU MDR, PMDA)

• Lead, conduct and own risk management activities including Hazard Analysis, System Risk Analysis, and various FMEAs (Design, Use, Process)

• Ensure compliance to ISO14971 and implementation of Risk Management best practices

• Ensure that FDA and other regulatory knowledge and experience is applied to risk and testing assessments

• Work with manufacturing engineering and contract manufacturing partners to ensure necessary process controls are in place for initial product launch and significant design changes

• Review and approve Change Requests and 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, ISO 14971, IEC 62366, 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

• Develop statistically sound sampling plans and perform data analysis

• Assess reliability growth strategies for the product and provide input to the engineering teams

• Build and maintain strong interpersonal relationships within and outside of the company