Does the idea of ensuring the quality of life-saving electro-mechanical devices appeal to you? Do you consider yourself an IEC 60601 expert? Would you be excited to contribute to industry-leading Class III medical device quality standards at one of the fastest-growing companies in the world? If so, consider the following opportunity.
This Senior Quality Engineer will be the subject matter expert for Abiomed’s main intelligent electro-mechanical control system, the “AIC”. As the lead quality engineer you will be responsible for driving quality-related engineering initiatives for new product development and product improvements, the risk evaluation and mitigation process and planning, assessment of software developmentand the testing processes and support of manufacturing and field service where appropriate.
KEY RESPONSIBILITIES
Responsible for strategically developing and finally executing quality and risk plans to ensure requirements are met during product development, product launch and throughout the full lifecycle
Insure that FDA and other regulatory knowledge and experience is applied to risk and testing assessments
Work closely with electronics and software suppliers and various internal functional groups in areas of quality including process development and the corrective actions
Responsible for working with design assurance engineering 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
Investigation and review of customer complaints, ensuring that root cause investigations are thorough and corrective / preventive actions are robust
Work with manufacturing engineering to ensure necessary process controls are in place
Review and approve Engineering Change Orders (ECO) and support the material review board (MRB) processes as needed
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
Assess reliability growth strategies in both systems and software and provide input to the engineering teams
Skills/Requirements
REQUIREMENTS
BS degree in a relevant Engineering discipline required (i.e., BSEE, CS); MS preferred
10 years of experience in a Quality Engineering role in the medical device industry
Experience supporting the design and manufacture of intelligent electro-mechanical medical devices used in a critical care setting
Working knowledge of Electrical, Safety, EMC compatibility and software testing standards
Experience in reliability and reliability growth engineering for Electro-mechanical systems and software
Demonstrated experience with formal problem-solving methodologies and deductive skills
Strong statistical / data analysis skills (e.g., Minitab)
Ability to communicate ideas and information clearly, effectively and frequently (oral and written)
Ability to exercise independent judgment in methods, techniques and evaluation criteria for obtaining results
Ability to act independently to determine methods and procedures
