Sr Design Quality Engineer

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

Qualifications

• Bachelor's degree in engineering or Sciences is required, Master's desired
• 5+ years of relevant Design Quality related experience
• Experience in the medical device industry, as well as cardiovascular space preferred
• Experience with complex electro-mechanical capital equipment with embedded software strongly preferred
• Demonstrated strong knowledge of quality engineering policies, principles and best practices and FDA/ISO requirements
• Takes initiative and demonstrates leadership and teamwork in a collaborative cross-functional environment

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.