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. 

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Product Requirements

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

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

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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.

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

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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.

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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.

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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.

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