Systems Engineer 4

Hologic•Newark, NJ

14h•Onsite

About The Position

The Lead Systems Engineer provides systems engineering leadership across hardware, software, mechanical, electrical, clinical, manufacturing, quality, and regulatory functions to ensure successful development and commercialization of safe, effective, and compliant products. They may serve as the technical leader responsible for the definition, architecture, integration, and lifecycle management of complex medical device systems. The individual drives requirement development, system architecture, risk management, integration, verification, validation, and design transfer activities while balancing technical, regulatory, schedule, cost, and quality objectives. The Lead Systems Engineer is recognized as a subject matter expert and influences technical strategy, engineering best practices, and product innovation across multiple programs. The Lead Systems Engineer works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results. Networks with key contacts outside own area of expertise. The Lead Systems Engineer has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Determines methods and procedures on new assignments and may coordinate activities of other personnel (Team Lead).

Requirements

Experience throughout the product lifecycle in development and sustaining of complex medical systems consisting of mechanical, electrical and software components within a regulated environment.
Experienced with automated tools for requirements and traceability management.
Experienced with automated tools for defect and issue tracking.
Comprehensive knowledge of systems engineering methodologies, physical and mathematical modeling tools, and ability to transform physical and mathematical concepts into sound engineering designs.
Expert proficiency in requirements management, traceability, and systems modeling methodologies.
Expert knowledge of the capabilities, limitations and interdependencies of hardware and software components within a complex system.
Demonstrated expertise in system integration, root cause investigation, and problem resolution.
Strong understanding of medical devices, FDA QSR and ISO 13485
Strong understanding of relevant risk and electrical safety standards, such as ISO 14971, IEC-60601-1, and IEC 60601-1-2.
Basic understanding of the software life cycle for medical devices in accordance with IEC 62304, ensuring compliance with relevant software development processes and cybersecurity considerations.
Understands complex Product Life Cycle Management systems and how they interface with other data management and compliance standards.
Excellent leadership, communication, negotiation, and stakeholder management skills.
Ability to influence technical decisions across organizational boundaries.
Ability to simultaneously manage multiple large-scale projects.
Excellent interpersonal skills- Ability to lead and motivate a team; Collaborate cross functionally; Efficiently direct and coordinate the work of others.
Ability to develop and deliver high quality presentations is beneficial.

Nice To Haves

Agile, Oracle is beneficial.

Responsibilities

Own the overall system architecture and ensure alignment between product requirements, subsystem requirements, interfaces, and verification strategies.
Lead system decomposition and allocation of requirements across software, hardware, electrical, mechanical, and clinical workflows.
Define system-level performance metrics and acceptance criteria to ensure successful product outcomes.
Lead system integration activities and resolve cross-functional technical issues affecting product performance, safety, quality, or usability.
Drive engineering trade-off analyses balancing performance, risk, usability, manufacturability, reliability, and cost.
Works closely with other engineers to develop an expert level of understanding of our products and their use in clinical practice to design, develop and sustain our next generation products.
Recognized cross functionally as a go to technical expert and acts as lead for assigned products and subsystems.
Develop and maintain component or high-level assembly purchasing specifications ensuring requirements are well defined, and suppliers can fulfill and test the specifications.
Accountable for verification and validation testing.
Oversee the fabrication of test control apparatus and equipment and determines methods and procedures and conditions for testing.
Leads and performs engineering activities to ensure manufacturing, construction, installation, and operational testing conform to functional specifications and customer requirements.
Use computer assisted engineering and design software to perform engineering tasks, create analytic tools and simulations to model system performance.
Ensure compliance with FDA Quality System Regulations, ISO 13485, IEC 62304, IEC 60601, ISO 14971, and other applicable standards.
Lead system-level risk management activities including hazard analysis, FMEA development, risk evaluations, and risk control effectiveness assessments.
Support regulatory submissions by contributing technical documentation and design evidence.
Ensure design control deliverables are complete, traceable, and audit ready throughout the product lifecycle.
Partner with Clinical Affairs, Marketing, and Customer Experience teams to translate user needs into actionable engineering requirements.
Drive incorporation of customer feedback, complaint investigations, and field learnings into product improvements.
Ensure system designs support clinical workflow efficiency, patient safety, and user experience objectives.
Ensures design, fabrication, maintenance, and repair methods/processes are developed, executed and documented in a manner which supports all quality standards.
Collaborates on the transfer of design to manufacturing.
Provide technical leadership across multiple product development programs.
Mentor systems engineers and cross-functional engineering teams in systems engineering best practices.
Lead technical reviews, architecture reviews, design reviews, and risk reviews.
Develop and institutionalize systems engineering processes, tools, and methods to improve organizational effectiveness.
Effectively coordinate and lead activities and support personnel to meet project objectives.
Provides regular communication and updates on success factors such as progress, schedule, budget, project risks and resource or needs gaps.
Maintains strong network and relationships with Design Assurance, Regulatory Affairs, Clinical Affairs, Clinical Applications, and other functional partners.
Leads collaborative efforts and the building of interorganizational networks.
Develop and institutionalize systems engineering processes, tools, and methods to improve organizational effectiveness.
Participates in professional development and stays current with new test technology and processes while actively seeking to implement new technology into new and existing design verification & validation activities.