Payroll Analyst supporting payroll operations and system enhancements at Old Republic Title. Serving as a subject matter expert for UKG BI reporting, payroll system upgrades, and process improvement initiatives.
About the role
- Principal Systems Engineer driving technical excellence within Lifecycle Engineering at Insulet Corporation. Leading cross-functional teams in product reliability and compliance efforts for medical devices.
Responsibilities
- Serve as a key member of a cross-functional project team consisting of electrical, software, mechanical, manufacturing, and quality engineers to achieve project deliverables.
- Lead sustaining engineering activities for in-market products, including post-market surveillance, field issue resolution, and obsolescence planning.
- Drive root cause investigations and corrective actions for field issues, complaints, and adverse events.
- Monitor and analyze field performance data to identify trends and proactively mitigate risks.
- Lead design changes and updates to improve product reliability, manufacturability, and compliance.
- Collaborate with Quality and Regulatory teams to provide technical context on design and ensure timely and compliant resolution of CAPAs and audit findings.
- Lead and mentor systems engineers and promote best practices in systems engineering across the organization.
- Create and maintain traceability among design input, design output, verification and validation, and risk management artifacts to ensure completeness and fully traceable design history file.
- Lead the design, development, execution of novel test methods and risk management activities utilizing best engineering practices.
- Lead integration, subsystem and system verification activities creating plans, protocols and reports as necessary.
- Support the preparation of proposals, project plans and estimates, and present information and status to leadership and other stakeholders.
Requirements
- A Bachelor of Science or equivalent degree in Systems Engineering, Electrical Engineering, Computer Science, Mechanical Engineering, or Biomedical Engineering is preferred.
- A minimum of 12 years of experience working as a Systems Engineer or with systems engineering responsibilities in a multidisciplinary project team environment.
- A minimum of 8 years of experience as a technical lead in cross-functional teams.
- Domain expertise in at least two disciplines; Mechanical, Electrical, Software.
- Experience with Requirement Management including Requirement Hierarchies, Traceability, Authorship, Platform vs Variant modalities.
- Experience with Preliminary Hazard Analysis (PHA), Fault Tree Analysis (FTA) and Failure Mode and Effect Analysis (FMEA).
- Experience with change management involving in-market products.
- Proficient with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls).
- Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team that includes development/verification/validation/procurement/manufacturing/regulatory and quality experts.
- Experience with IEC 60601 family of standards, particularly in the context of electro-medical safety and performance.
- Hands-on experience with Bluetooth Low Energy (BLE) integration in medical or consumer devices.
- Proven experience with disposable product design, especially in high-volume manufacturing environments.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
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HÖ
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