Design Quality Engineer- 2+ yrs- New York, New York- Onsite

ResponsibilitiesProvide Design Quality Engineering support throughout the product developmentlifecycle ensure compliance with regulations and internal Quality ManagementSystem procedures.Provide support to new product development and sustaining engineering projectsincluding review and approval change orders.Use technical expertise, knowledge, and experience to rapidly innovate thecompanies’ medical devices for use in chronic heart failure patients.Facilitate and conduct risk management activities including development of RiskManagement Plans, Hazard Analyses, Design Failure Modes and EffectsAnalysis () and Risk Management Reports.Participate in reviewing design inputs and design output requirements, ensurerisk control measures and cybersecurity requirements are transformed intoproduct requirements.Participate in V&V activities, review verification and validation plan, test protocolreports.Participate in product cybersecurity activities including product security planning,threat analysis, cybersecurity risk assessments, periodic monitoring andreporting.Apply sound, systematic problem-solving methodologies in identifying,prioritizing, communicating, and resolving quality issues as related to the positionresponsibilities.Contribute to the success of the Quality System performance measures bycompleting tasks on time and with a high level of QualityProvide support during Corrective and Preventive Action (CAPA) activities andmanage the CAPA system as necessary.Support 3rd party audits, including follow-up on actions and quality departmentinitiatives.Ensure compliance of QMS through authoring and updating Standard OperatingProcedures (SOP).