Engineering Manager, System Manager

hace 1 semana

México BC Insulet Corporation A tiempo completo

In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.
We are looking for highly motivated, performance driven individuals to be a part of our expanding team. Our continued success depends on it

Job Title: Manager, Systems Engineering
Department: Systems Engineering LCE
Manager, Systems Engineering

The Manager, Systems Engineering will provide leadership through motivation, guidance, and open communication enabling the team’s growth and success. They will manage a team of systems engineers balancing technical expertise and leadership while ensuring technical risk reduction in engineering programs. Manager will oversee post-market activities, including field investigations, CAPA execution, and obsolescence planning; they will drive continuous improvement to support product development and lifecycle management for in-market and near-market products.

Attract, develop and retain the best talent to ensure the highest standard of excellence in systems engineering resulting in the delivery of high-quality innovations to patients globally.
Manage the development of hardware and software enabled systems, those that interact with human or machines, and functional activities relevant to achieving these goals. This includes driving functional excellence in identifying, breaking down and solving technical problems associated with design and development of system architectures, testing, product and other system engineering aspects.
Champion best-in-class systems engineering methodologies, optimizing workflows and efficiency.
Drive post-market initiatives, including field investigations, CAPAs, failure and risk analysis, health-hazard analysis and obsolescence planning.
Ensure traceability among design input, design output, verification/validation, and risk management artifacts to maintain a complete design history file within QMS compliance.
Collaborate cross-functionally including but not limited to Customer Support, Product Support, R&D SW development, Product Management, Regulatory, Quality, DevOps.
Drive continuous improvement initiatives, refining systems engineering processes for better quality, compliance, and adherence to ALM and PLM frameworks.

Skilled in cross-functional collaboration, coordinating with leadership, technical experts, and external partners.
Bachelor of Science or higher in System Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related field.
Minimum of 8 years of overall experience in systems engineering, lifecycle engineering, sustaining, R&D, or related technical roles in medical devices or other regulated industries.
At least 4 years of team leadership experience, which may include roles: managing direct reports, technical lead or project lead, in which candidate lead engineers.
Risk Analysis, Issue Management, Change management, and Root Cause Investigation Methods
CAPA execution, failure analysis, and post-market regulatory compliance

Graduate Degree (MSc, PhD) in Engineering or Management.
Excellent verbal and writing skills that enable communication to different levels.
Six Sigma training or certification.

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