Design Quality Engineer

Design Quality Engineerlocal to Danvers, MA.12+MonthThe ideal candidate for the Design Quality Engineer position will support various New Product Development and sustaining activities as well as play a role in product risk management, cybersecurity, change controls, and design controls.This engineer should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. Be ready to make a significant contribution to a dynamic, fun, multi-disciplinary team, where a self-motivated engineer with excellent written and verbal communication skills stands ready to succeed.Seize the opportunity today to join this collaborative, high performing team within the fastest growing business in MedTech. Come join our Abiomed team today!Key Responsibilities:Provide Design Quality Engineering support throughout the product development lifecycle to ensure compliance with regulations and internal Quality Management System procedures.Provide support to new product development and sustaining engineering projects including review and approval change orders.Use technical expertise, knowledge, and experience to rapidly innovate the companies’ medical devices for use in chronic heart failure patients.Facilitate and conduct risk management activities including development of Risk Management Plans, Hazard Analyses, Design Failure Modes and Effects Analysis () and Risk Management Reports.Participate in reviewing design inputs and design output requirements, ensure risk control measures and cybersecurity requirements are transformed into product requirements.Participate in V&V activities, review verification and validation plan, test protocol reports.Participate in product cybersecurity activities including product security planning, threat analysis, cybersecurity risk assessments, periodic monitoring and reporting.Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.Contribute to the success of the Quality System performance measures by completing tasks on time and with a high level of QualityProvide support during Corrective and Preventive Action (CAPA) activities and manage the CAPA system as necessary.Support 3rd party audits, including follow-up on actions and quality department initiatives.Ensure compliance of QMS through authoring and updating Standard Operating Procedures (SOP).QualificationsEducation:A minimum of a bachelor’s degree in engineering or scientific discipline is required. An advanced degree in a related field is also an asset.Experience and SkillsRequired:Minimum 5 years of work experience in a highly regulated industry is required or equivalent to a master’s degree in engineering or scientific discipline. Medical Device and/or Biotechnology industry is preferred.Working experience and Knowledge of quality system regulation, including 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR.Experience conducting and furnishing RMF and Design Failure Mode Effects and AnalysisDemonstrated and impactful experience in design control and risk management activities.Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and international.Preferred:Work experience in electro-mechanical devices.Familiar and working experience in CI tools, reliability and statistical sample sizeOther:This position will require working onsite in Danvers, MA with a minimum of 3 days per week and will require 10% of domestic and/or international travel.