Principal Systems Engineer.

Position Description :

Principal Systems Engineer for Covidien LP (a Medtronic company) located in Boston, MA. Responsible for technical functions to advance existing technology or introduce new technology and therapies.

• Provide Electrical Engineering (EE) support related to the regulatory requirements of different countries for Class II and Class III medical devices;
• responsible for GEO expansion by providing Systems Engineering support to release new products to new Geographies; responsible for CAPA projects and engineering support of supplier change processes for product and component issues;
• review International standards for conformance to release new product to new Geographies; coordinate Design Control process to create design inputs / outputs and perform design changes;
• responsible for presenting devices to patients and clinicians, to requirements definition and architectural design for future or updated systems, to implementation verification and validation in preparation for commercial release and human utilization;
• utilize system engineering methodologies by understanding and adhering to FDA QSR (Quality System Regulation) requirements and 21 CFR 820;
• coordinate reliability testing and modeling techniques to include DOE (Design of Experiment) and FMEA (Failure Mode and Effect Analysis);
• work on generating technical documentation to include specifications, technical plans, protocols and reports; author various system level requirements with traceability for verification and validation testing by establishing strategies to ensure testability of system requirement relative to use conditions;
• work on the development and implementation of approaches that comply with international standards including IEC 60601, ISO 13485,ISO 14971, ISO 20417, and ISO 15223-1;

work on development of new and support of current electromechanical subsystems of Medical devices using CAD and simulation tools like ORCAD, ALTIUM, and SOLIDWORK.

Position works a hybrid model and will be onsite in Boston, MA 3 days / week. Relocation assistance not available for this position.

If selected, candidate will be responsible for relocating at their own expense to report to the worksite.

Basic Qualifications :

Requires a Master’s degree or foreign equivalent in Electrical, Software, Systems or Biomedical Engineering and five (5) years of experience as a systems engineer or related occupation in systems engineering.

• Must possess at least five (5) years of experience with each of the following : Class II and Class III medical devices; FDA QSR (Quality System Regulation) requirements and 21 CFR 820;
• reliability testing and modeling techniques to include DOE (Design of Experiment) and FMEA (Failure Mode and Effect Analysis);
• generating technical documentation to include Design specifications, technical plans, protocols, and reports; writing system level requirements with traceability for verification and validation testing;

IEC 60601 series of standards, ISO 13485, ISO 14971, ISO 20417, and ISO 15223-1; and developing and supporting electromechanical sub-system of medical devices using CAD and simulation tools including ORCAD, ALTIUM and SOLIDWORK.

Position works a hybrid model and will be onsite in Boston, MA 3 days / week. Relocation assistance not available for this position.

If selected, candidate will be responsible for relocating at their own expense to report to the worksite.

LI-DNI