Quality Design Engineer 2

Hologic•San Diego, CA

About The Position

As a key member of the Quality Engineering team at Hologic, the Design Quality Engineer plays an integral role in supporting quality activities related to Design Control efforts in accordance with FDA, ISO, and other IVD regulations. This individual also supports the company’s quality system activities that comply with the FDA’s Quality System Regulations (QSRs), ISO 13485, and applicable state requirements. The successful candidate will work with product development teams to ensure that appropriate design control measures are applied during the development and transfer of Hologic products. The individual will apply “systems” thinking and knowledge of medical device products, molecular diagnostics, regulatory standards or applicable industry, design verification and validation, manufacturing transfer, test method development principles, and risk management to support new and sustaining projects. Essential Duties and Responsibilities The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs. Work effectively and influence multiple functions (R&D, Software & Hardware Engineering, Assay Development, System Integration, Program Management, Regulatory Affairs, Supplier Quality, Supply Chain, Operations, etc.) to ensure teams understand and implement appropriate regulations for all areas of design controls, including risk management, development planning, inputs, user needs, design requirements, specifications, traceability, outputs, critical to quality (CtQ), design review, verification, validation, change control, protocols, and reports. Provide Quality Engineering support for product design and development from feasibility through transfer into commercialization, post launch surveillance and change management activities. Support Research and Development teams with platform or systems reliability testing and characterization with both hardware and software. Review and critique design solutions developed by other team members. Ensuring the design complies with regulatory standards including EN60601, ISO13485 and ISO14971. Serve as Core team member on New Product Development projects to ensure compliance with design controls per ISO 13485 and FDA QSR. Participate in project teams to review and update clear and concise User Requirements, Product Specifications, Plans, Verification and Validation Studies, Risk Management File and other relevant design control deliverables. Lead or support non-conformance or CAPA related initiatives. Review and support compliance studies to ensure device electrical safety is maximized mitigated through standardized approach in conforming to IEC 60601. Work closely with Research and Development organizations to ensure potential product issues are identified and addressed in the design. Work with product development teams to assess design changes from a systems perspective, identifying risks, delivering design mitigations and evaluating the effectiveness of the risk control measures. Support FMEAs and other risk assessment processes and documentation. Support design control and risk management activities, review/approve design control and risk management documentation ensuring compliance to established requirements. Anticipate and manage project risks and issues. Work on complex technical problems, utilize quality engineering methods and provide innovative solutions. Provide guidance to core team members and key stakeholders on Quality Systems requirements and Design Controls. Support regulatory inspections and audits associated with design control documentation. Participate in process improvement opportunities. Provide management with status updates on assigned responsibilities, goals, and escalate issues in a prompt manner. Assist in development, maintenance, and reporting of departmental metrics.

Requirements

Minimum of a Bachelor of Science degree in a related life sciences or engineering degree in chemical engineering, chemistry, bio-chemistry, biomedical engineering, molecular and cell biology, microbiology, biology
Two to five years Quality Engineering and/or development experience in product development, product transfer, verification, and validation under Design Control in the life sciences industry, preferably in an FDA regulated medical device/IVD environment.
Working knowledge of Quality Management System for Medical Device Manufacturing FDA 21 CFR 820, ISO 13485 as well as CE mark requirements, MDD / IVDD / IVDR / MDR / IEC 62304, MDSAP, CDRH regulations, Risk Management ISO 14971, and other applicable quality and regulatory standards.
Experience and understanding of design, development, verification, and validation processes.
Strong knowledge of scientific principles and concepts.
Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment.
Effective verbal and written communication skills and the ability to share and receive information from all levels of the organization throughout various departments.
Influencing and negotiation skills highly preferred
Strong working knowledge of design control, assay, software and hardware V&V, change control, and documentation requirements.
Experience with electronic product life cycle (PLM) and enterprise resource planning tools (ERP).
Experience with enterprise Quality System tools (e.g., electronic CAPA, Complaint Management systems)
Demonstrate working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements.

Responsibilities

Work effectively and influence multiple functions (R&D, Software & Hardware Engineering, Assay Development, System Integration, Program Management, Regulatory Affairs, Supplier Quality, Supply Chain, Operations, etc.) to ensure teams understand and implement appropriate regulations for all areas of design controls, including risk management, development planning, inputs, user needs, design requirements, specifications, traceability, outputs, critical to quality (CtQ), design review, verification, validation, change control, protocols, and reports.
Provide Quality Engineering support for product design and development from feasibility through transfer into commercialization, post launch surveillance and change management activities.
Support Research and Development teams with platform or systems reliability testing and characterization with both hardware and software.
Review and critique design solutions developed by other team members.
Ensuring the design complies with regulatory standards including EN60601, ISO13485 and ISO14971.
Serve as Core team member on New Product Development projects to ensure compliance with design controls per ISO 13485 and FDA QSR.
Participate in project teams to review and update clear and concise User Requirements, Product Specifications, Plans, Verification and Validation Studies, Risk Management File and other relevant design control deliverables.
Lead or support non-conformance or CAPA related initiatives.
Review and support compliance studies to ensure device electrical safety is maximized mitigated through standardized approach in conforming to IEC 60601.
Work closely with Research and Development organizations to ensure potential product issues are identified and addressed in the design.
Work with product development teams to assess design changes from a systems perspective, identifying risks, delivering design mitigations and evaluating the effectiveness of the risk control measures.
Support FMEAs and other risk assessment processes and documentation.
Support design control and risk management activities, review/approve design control and risk management documentation ensuring compliance to established requirements.
Anticipate and manage project risks and issues.
Work on complex technical problems, utilize quality engineering methods and provide innovative solutions.
Provide guidance to core team members and key stakeholders on Quality Systems requirements and Design Controls.
Support regulatory inspections and audits associated with design control documentation.
Participate in process improvement opportunities.
Provide management with status updates on assigned responsibilities, goals, and escalate issues in a prompt manner.
Assist in development, maintenance, and reporting of departmental metrics.