Product Development & Manufacturing
Long-term ownership of complex hardware in regulated, high-volume environments.
Professional Background
I’ve spent over seven years working on neurosurgical medical devices produced at scale. These are mature products where reliability and patient impact are essential, and every change has to be weighed against manufacturing, quality, and regulatory consequences.
Ownership Across Roles
I began in manufacturing engineering, supporting multiple neurosurgical product lines and transferring Codman production from J&J to Integra, including plant startup. The role meant hands-on troubleshooting of equipment and systems, developing fixtures and processes, and executing validation work during ramp-up and sustained production.
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Today I work on many of those same products from the product development side. I own the mechanical scope for electromechanical devices such as ICP sensors and accessories, and provide technical leadership for new site introductions and regulatory remediation. This work requires close coordination across engineering and manufacturing.
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I also remain a subject-matter expert for the cranial Perforator line, focusing on FDA readiness, CTQ development, design investigations, and ongoing support.
Production Experience
Working in high-volume manufacturing, I saw how design and planning decisions became stoppages, quality issues, audit findings, or simply made products harder to build and assemble. That experience guides the decisions I make that the people building, testing, and supporting the products will live with.
Design Judgement
In product development, a big part of my job is maintaining and clarifying the technical definition of mature products. I align drawings, CTQs, specifications, and test methods with how devices are built and verified so execution remains consistent over time.
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I evaluate design updates through cost-benefit, risk, and operational impact. Often the better move is improving understanding, documentation, or testing rather than changing hardware, reserving redesign for cases that clearly improve performance, patient outcomes, or manufacturability.
My Approach
Across roles, I’m often asked to step into high-priority, high-scrutiny work, often stepping away from planned projects to close urgent gaps and bring difficult efforts over the line in ways that stand up over time.
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I try to bring the same focus to everything I work on, whether developing a test method, designing hardware, or maintaining my offshore boat.