Senior Compliance Engineer

Siemens Healthineers

3d•$118,300 - $162,668

About The Position

The Senior Compliance Engineer will lead compliance engineering and product safety strategy for EVR across the Monadnock program and other product development efforts. The role interprets applicable standards and derives system-specific product safety and compliance requirements for design teams. It partners with mechanical, electrical, consumables, and software engineers throughout requirements development, early design, design reviews, and compliance verification. The engineer plans and manages compliance testing with external verification laboratories, leads compliance verification planning and execution, and authors or co-authors test plans, protocols, methods, and reports. The role also supports product safety risk management, tracks compliance status and resolution of findings, maintains compliance documentation in EVR’s quality management system, and communicates with stakeholders while mentoring design engineers on compliance and standards. Travel of up to 20% is expected.

Requirements

Minimum of 8 years of medical device compliance and product safety engineering experience.
Bachelor’s degree in Electrical, Mechanical, Biomedical, or Systems Engineering, or a closely related field.
Solid, hands-on experience with medical device compliance testing and engineering.
Strong working knowledge of standards applicable to complex active medical devices, including IEC 60601-1 and applicable collateral and particular standards, IEC 60601-1-2, ISO 14971, ISO 13485, FDA 21 CFR 820, and IEC 62304.
Knowledge of ISO 10993 and applicable sterilization standards for sterile single-use consumables.
Demonstrated experience working with external compliance and test laboratories, such as TÜV or equivalent, to test medical devices.
Experience interpreting standards and translating clauses into system-specific design and verification requirements.
Experience with design reviews and design control procedures.
Strong documentation and communication skills.
Willingness to travel up to 20%.

Responsibilities

Lead compliance engineering and product safety strategy for EVR across the Monadnock program and other product development efforts.
Identify applicable standards, interpret their clauses, and derive system-specific product safety and compliance requirements for design teams.
Partner with mechanical, electrical, consumables, and software design engineers from requirements development and early design through design review and compliance verification.
Plan, coordinate, and manage compliance testing with external verification laboratories, and own relationships with those laboratories.
Participate in design reviews in a compliance capacity to ensure designs meet compliance requirements.
Lead compliance verification planning and execution, and author or co-author compliance test plans, protocols, methods, and reports.
Support product safety risk management and ensure compliance findings drive appropriate requirements and risk updates.
Track program compliance status and drive timely resolution of findings.
Maintain compliance and product safety documentation within EVR’s quality management system.
Communicate with cross-functional stakeholders and mentor design engineers on compliance and standards.