Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Staff Design Quality Engineer II located in Danvers, MA.
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 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 existing and nextgen product development spanning single-use long duration heart pumps, capital equipment controllers, and algorithm development. Key Responsibilities : Support and Lead Design Assurance engineering activities in support of Abiomed's Product Development and Life Cycle processes including 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 Insure that FDA and other regulatory knowledge and experience is applied to risk and testing assessments Work with manufacturing engineering to ensure necessary process controls are in place for design changes. Review and approve Engineering Change Orders (ECO) and support the material review board (MRB) processes 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, MDD, 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 Collect, analyze & report on quality system metrics: CAPA, complaint trends, manufacturing trends, etc. Develop statistically sound sampling plans and perform data analysis Assess reliability growth strategies in both systems and software and provide input to the engineering teams Participate in design reviews for the system as well as review and approve design input/design requirements, design documents, test results, verification and validation Bachelor degree in Engineering or Sciences is required, Masters desired Minimum of 6 years of quality experience Minimum of 3 years with design control experience Experience in the medical device industry as well as with electro-mechanical systems and/or cardiovascular devices highly preferred Demonstrates strong knowledge of quality engineering policies, principles and best practices and FDA/ISO requirements Ability to work with cross-functional teams e.g Regulatory, Operations, Project Management, Supply Chain etc Takes initiative and demonstrates leadership and team work For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $100,800 to $140,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long-term incentive, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. For additional general information on company benefits, please go to: 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.
