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  1. Being an Engineer
  2. S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA
S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA

S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA

Being an Engineer · Feb 6, 2026

Med device leader Bob Hankins discusses navigating FDA regulations, using FMEAs for risk mitigation, and scaling teams through empowerment.

Engineers Should Take Negotiation Courses to Bridge Business and Technical Divides

Miscommunication with non-technical stakeholders (finance, sales) is a common failure point. Engineers should take negotiation courses to frame technical problems in terms of business needs, do their research, and present a case effectively to get buy-in.

S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA thumbnail

S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA

Being an Engineer·13 days ago

When Facing the FDA, Prioritize Product Integrity Over Business Fears

Dealing with regulatory bodies can be terrifying, especially for a startup facing a recall. The key is to present objective facts, demonstrate a rigorous process, and make decisions that protect the product and patient. This builds trust and ensures long-term viability.

S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA thumbnail

S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA

Being an Engineer·13 days ago

A Knowledge Worker's Vacation Is Successful If They Forget Their Passwords

For engineers and other knowledge workers whose brains are always "on," a true mental break is essential for avoiding burnout. A good heuristic for a successful, restorative vacation is returning so mentally disconnected from work that you've forgotten your passwords.

S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA thumbnail

S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA

Being an Engineer·13 days ago

Complex Product Failures Live in Undefined Cross-Disciplinary Requirements

In complex systems (e.g., electromechanical devices with software), problems often arise not within a single discipline but in the interactions between them. Engineers must adopt a systems-level view to anticipate and address these "undefined requirements" where different components intersect.

S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA thumbnail

S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA

Being an Engineer·13 days ago

Peter Drucker Taught That Standardization Enables, Not Hinders, Innovation

Contrary to belief, standards and structured processes don't stifle creativity. As management expert Peter Drucker argued, standardization provides a stable foundation that handles the knowns, freeing up cognitive resources to innovate on the unknowns within a structured, less risky environment.

S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA thumbnail

S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA

Being an Engineer·13 days ago

Medical Device Startups Learn Documentation Isn't Bureaucracy, It's Survival

In high-stakes regulated fields, documentation like FMEAs is not red tape. It's a critical tool for understanding failure modes, mitigating risks, and ensuring product viability and patient safety, especially for a startup where one recall can be fatal.

S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA thumbnail

S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA

Being an Engineer·13 days ago

Aspiring Engineering Managers Should Go Technically Broad, Not Deep

To transition into management, engineers should prioritize gaining broad technical knowledge across disciplines. This breadth allows them to understand team-wide pain points, facilitate collaboration, and implement effective systems, rather than being the deepest expert in a single area.

S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA thumbnail

S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA

Being an Engineer·13 days ago