Sean Connell

Results-driven System Engineer with over 20 years of experience in the Medical Device industry. Expertise in the development and commercialization of bioresearch and medical equipment, with a strong focus on documentation control for engineering, manufacturing, and service support operations. Proven ability to communicate effectively and solve complex problems, consistently surpassing customer expectations.

• Expert knowledge of federal and international standards.
• 21 CFR Part 820 Quality System Regulation, 21 CFR Part 11 Electronic Records; Electronic Signatures, ISO 13485 Medical Devices – Quality Management Systems’
• ISO 14971 Medical Devices – Application of Risk Management to Medical Devices, IEC 62304 Medical Device Software – Software Life Cycle Processes, IEC 60601 series of technical standards for safety and essential performance. IEC 61010
• Systems Engineering Processes and Process Development.
• Product Lifecycle Management (PLM)/System Lifecycle
• ISO/IEC/IEEE 15288:2015, Systems and Software Engineering – Systems life cycle processes, Guide to the Systems Engineering Body of Knowledge (SEBoK), INCOSE Systems Engineering Handbook 4th edition
• Product Development Process (PDP)
• Experienced in and familiar with Agile (Flexible Product Development), Stage-Gate, Lean Product development, Design for Six Sigma, Quality Function deployment, User-Centered Design.
• Developed and refined product development processes for FDA/IEC compliance.
• Refined or modified PDP processes to address internal or external audit concerns.
• Defined document types and structures used in systems engineering department. Including creation of templates and example documents to be used in training
• Oversaw, developed, managed, reviewed and executed verification and validation testing. Including test method and test software validation.
• Collected and defined stakeholder requirements through to system and sub-system level requirements. This included initiation of user needs with customers, patients, sales personnel manufacturing and other groups. (MRDs, PRDs, SRDs, System Architecture, etc.)
• Lead cross function development through requirements and analysis with software, mechanical and electrical engineering teams.
• Lead certification of medical devices and components for 60601 and 61010 with third-party testing agency.
• Requirements Management and Requirements Management Systems
• Evaluated, acquired and implemented requirements management systems
• Proficient in Doors, Visure and Polarion requirement software.
• Converted existing paper-based systems with manual tracking to automated and integrated systems complete with electronic signatures.
• Integrated systems databases to included one to one tracing of requirements all the way to test results including documented hazards and mitigations.
• Drove for development of standard forms, processes and procedures to streamline development timelines and increase test case reusability.
• Risk Management and Failure Processes
• Patient Risk assessments, Product risk assessments, DFMEA, Hazard Analysis.
• Experienced in failure analysis, remediation and reports as required including CAPA activities.
• Risk to requirements tracing to assure mitigations have been devised and implemented.
• Root Cause investigations
• Experienced in and have trained the following investigative techniques the 5 Whys, Fishbone, Brainstorming and Flowcharting.
• Experienced in conducting and reviewing and reporting of one off and multiple occurrence failures.
• Mentored less experienced team members in investigations, reports and solutions for root cause work.
• Participated and aided CAPA investigations, including providing documentation for closure or further work.
• Engineering Background and Skills
• Software development for both product and test software
• Service engineering including onsite and remote subject matter expert. Generated service requirements and service documentation along with test and calibration procedures.
• Hardware development of both mechanical and electrical hardware components and systems
• Experienced integration engineer.
• Hardware testing for CE/UL certification
• Automated test fixture development using LabVIEW.
• Proficiency with Multimeters, oscilloscopes, spectrum analyzers and other test equipment
• Testing process development for manufacturing and service personal.
• Experience if test fixture development.
• LINAC and Magnetron Development
• High Power RF system design
• Cooling system design.