Responsibilities:
• Represent the Quality Department as a subject matter expert in Design Control within cross-functional teams assisting in the development, review, and execution or approval of traceable design inputs/outputs.
• Support design verification and validation activities by assisting in the development and review of test plans, protocols, and reports, including specific compliance testing (e.g., IEC-60601-1, ISO-10993-1, etc.)
• Participate in the development of medical device software compliant with IEC-62304 and relevant regulations.
• Lead risk assessment and ensure that risks are identified, analyzed, and mitigated in accordance with ISO-14971 throughout the design process and compiled in the Risk Management File.
• Lead the development FMEA (Use, Design, Software, Process) to systematically address potential failure mode.
• Support the development of the Usability Engineering File in accordance with IEC-62633 and applicable regulations.
• Assist in the manufacturing transfer process including the creation and completion of planning documentation, DMR/DHR, and validation protocols (IQ, OQ, PQ).
• Support other duties as assigned by manager.
Required Knowledge/Skills, Education, and Experience
• Bachelor’s degree required in Engineering, Biomedical Engineering, or Life Sciences.
• Minimum of 8 to 10 years of experience as a Quality or Design Quality Engineer in the medical device industry supporting the development of complex electro-mechanical devices is required.
• Experience with new product development required.
• Working knowledge of QSR, MDD/MDR, ISO-13485 and ISO-14971 is required.
• Experience supporting the development of compliant medical device software or SaMD (i.e, IEC 62304/82304) and SWFMEA development is required.
• Strong organizational skills, detail oriented, and the ability to meet changing deadlines on a fast-moving environment.
• Ability to communicate effectively within a technical environment.
• Team player who celebrates winning together
• No travel required.
Preferred Knowledge/Skills, Education, and Experience
• Experience with single use consumable development and specific experience with ISO 10993-1 :2018, ISO 11607-1:2019, ISO 11135:2014 is preferred.