Product Development & Manufacturing
This work reflects 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 in regulated environments. These are mature products where reliability and patient impact matter, and changes must be evaluated carefully against manufacturing, quality, and regulatory consequences.
Ownership Across Roles
I started in manufacturing engineering, supporting multiple neurosurgical product lines and transferring Codman product manufacturing from J&J to Integra, including production startup. That work involved hands-on troubleshooting of equipment and processes, process and fixture development, and executing validation activities during ramp-up and sustained production.
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Today, I support many of the same products from the product development side. I was hired to own the mechanical scope for electromechanical neurosurgical devices such as ICP sensors and accessories, providing technical guidance for new manufacturing site introductions and regulatory remediation. At the same time, I remain a subject-matter expert for the cranial Perforator product line, where most of my time has focused on FDA readiness, CTQ development, design investigations, and ongoing product support.
Production & Manufacturing Experience
Working in manufacturing put me close to problems that aren’t obvious until systems are in production. I spent significant time troubleshooting machines and processes, investigating and resolving yield and quality issues, and keeping production running during transfers—often across multiple products at once.
Seemingly small decisions in planning and execution routinely surfaced later as production stoppages, quality issues, audit findings, or corrective actions, particularly at volume. Seeing those consequences firsthand made downstream impact impossible to ignore.
Design Judgment
In product development, much of my responsibility has been maintaining and clarifying the technical definition of mature products. This includes aligning drawings, CTQs, specifications, and test methods with how the product is manufactured and verified, so execution stays consistent over time.
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I’ve evaluated potential design updates with a focus on cost-benefit, risk, and downstream impact. In several cases, the right decision was to improve understanding, documentation, or testing rather than change hardware—reserving redesign for situations where it clearly improves performance, patient impact, or manufacturability.
How This Shaped My Approach
​Across roles, I’ve been trusted to take on high-priority, high-scrutiny work—often being redirected from planned projects to close urgent gaps or investigations where getting it right mattered more than visibility. That trust has come from following issues through carefully and owning outcomes across functions.
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This same approach draws me toward field-deployed hardware, where systems operate outside controlled environments and reliability depends on understanding environmental and operational constraints and owning results over the long term—the same mindset I apply across my work, whether developing a test method, designing fixturing, or maintaining my offshore boat.