Professional Skills

Market Research

To determine product roadmap contents and timing, I have conducted direct customer surveys, customer interviews, led focus groups, surveyed sales and customer support operations representatives and tracked RMA trends.

Product Requirements

The output of market research I have translated into statements of intended use, product objectives, and specifications to guide engineering design.

Product requirements have included functional, performance, interoperability, regulatory, usability, and risk management.

Design Guidance and Specifications

While guiding product development projects, I have worked in both waterfall and agile development workflows, leading daily stand-up meetings, weekly cross departmental status reviews and design review meetings. In this role I have interpreted requirements for engineers and approved engineering design documentation.

I have authored multiple detail requirement documents creating algorithms (self coded/tested in MATLAB) to address industry needs or electrical design limitations.

Verification & Validation Activities

I have verified high level user requirements as well as low level "physics" requirements.” In addition, I have worked with beta partners to validate product objectives to ensure product usability goals have been met.

Regulatory

I have been responsible for multiple regulatory documentation including:

FDA: I have created the documentation packages for 510K submittals and managed determination of 510K submittal applicability.
IEC 60601-1(-2): I have worked with TUV, documenting compliance with IEC guidelines.
IEC 60732: I have led verifying electrometer compliance with IEC standards.
IEC 62336: I have conducted usability studies and documented results.
Clinical Evaluation Reports (CER): I have authored CERs identifying published risks and amended risk management reports and risk related requirements.

Internal / External Point-of-Contact

I have served as the point-of-contact for escalated engineering and physics requests. This includes customer support escalation, manufacturability requests, manufacturing yield improvement requests and key accounts support.

I have extensive experience communicating product features and operation through live presentations and web videos for existing and potential customers.

I have extensive background implementing and managing every phase (conception to market availability) of the product development life-cycle including market research, collecting and documenting product requirements, guiding design specifications, verification & validation activities, overseeing regulatory compliance, overseeing risk management and managing change request activities.