Medical devices
10 medical device design controls experts
These ten professionals have owned or led design controls inside medical device companies, in design control, design assurance and design quality roles. A reader can learn how device companies set up and run design control processes during product development.
Professionals to explore
01—10Dave Fiscella
LinkedInExperience: Senior Manager, Design Assurance · Teleflex
Senior Manager, Design Assurance at Teleflex since June 2023. The profile describes responsibility for the site (Interventional Urology) design assurance team, serving as Person Responsible for Regulatory Compliance (PRRC) designee, and owning Design Control, Risk Management and Post Market Surveillance for the site. Other listed Teleflex roles include Senior Manager, Engineering Services (2022–2023).
Dusty Needham, MS, EI, CQE, CQA
LinkedInExperience: Chief Engineer, Design Controls, R&D · VB Spine
Chief Engineer, Design Controls, R&D at VB Spine since April 2025, a role the profile says continued after VB Spine's acquisition of Stryker Spine and included leading the transformation of R&D infrastructure, including new systems, processes and procedures. Other listed roles include Chief DPO, R&D at Stryker (2021–2025) and Director of Product Development at OrthoGrid Systems, Inc. (2021).
Elodie Legentilhomme
LinkedInExperience: Senior Manager Design Assurance Quality Engineering · BD
Senior Manager Design Assurance Quality Engineering at BD since September 2022. The profile describes managing the quality engineering team and ensuring planning and execution of quality plans covering project activities such as risk management, design control, validation, product and process control strategies and supplier qualification. Also Project Quality Manager (2020–2022) and Project Quality Engineer (2017–2020) at BD.
Jonathon Lough
LinkedInExperience: Senior Quality Engineer · Viveve, Inc.
Former Senior Quality Engineer at Viveve, Inc. (2021–2023). The profile describes developing the Viveve design control process to comply with ISO 13485 and 21 CFR 820.30, including SOPs for design planning, design inputs, design outputs, verification and validation, design reviews and design transfer. Also Quality Engineer - Design Control at BioIntelliSense, Inc in 2023 and Design Quality Engineer 3 at Terumo Blood and Cell Technologies (2018–2021).
Josh Rowlands
LinkedInExperience: Design Quality Engineering Manager · NuVasive
Design Quality Engineering Manager at NuVasive since November 2022, and Design Quality Associate Manager there from 2021 to 2022. The profile describes responsibility for bringing French and Denver locations on to ISO 13485 certification and for implementing design controls. Other listed roles include Senior Manufacturing Engineer at Zimmer Biomet (2018–2021).
Krunal Patel
LinkedInExperience: Senior Quality Engineer - Design Controls (Design Quality Assurance) · Fresenius Medical Care
Former Senior Quality Engineer - Design Controls (Design Quality Assurance) at Fresenius Medical Care (2015–2018) and Quality Engineer Design Controls there (2012–2015). The listing also shows Manager, Design Assurance at Fresenius Medical Care (2018–2019) and Director, Design Quality Engineering at Johnson & Johnson MedTech since July 2023.
Krushika Shah
LinkedInExperience: Design Control Manager Site Quality Lead · Dentsply Sirona
Design Control Manager Site Quality Lead at Dentsply Sirona since May 2026. The listing also shows Senior Quality Engineer at Abbott (2022–2026) and Sr Quality Engineer at Gramercy Extremity Orthopedics (2018–2019). The profile summary describes knowledge of standards including ISO 13485, ISO 14971 and the Quality System Regulation (21 CFR Part 820).
Nancy Androff
LinkedInExperience: Design Assurance Manager · Boston Scientific
Former Design Assurance Manager at Boston Scientific (2015–2024), and Senior Fellow Design Assurance there since March 2025. The profile says the person developed and implemented company wide design control and risk management systems, with system development from local to global implementations. Other listed Boston Scientific roles include Principal Design Assurance Engineer (2010–2015).
Sara Lejon
LinkedInExperience: Design Control Group Lead · CMR Surgical
Design Control Group Lead at CMR Surgical since May 2022, and Principal Design Control Engineer there since October 2025. The listing also shows Staff Design Control Engineer (2022–2025) and Senior Design Control Engineer (2020–2022) at CMR Surgical. The profile describes CMR Surgical as a medical device company that developed the Versius surgical robotic system, and says the person's main focus is design controls.
Tim Bickerstaff
LinkedInExperience: Manager, Design Controls, Flexible Endoscope Development · KARL STORZ North America
Former Manager, Design Controls, Flexible Endoscope Development at KARL STORZ North America (2019–2024), and Supervisor, Design Control, Flexible Endoscope Development there from 2008 to 2019. The listing also shows Design Control Specialist, Engineer V (2024–2026) and Project Manager Mechanical Engineer, Flexible Endoscope Development (2004–2008) at KARL STORZ North America.
Choose the right perspective
Match the person's seat to your question, since building a company-wide design control process differs from running design controls on a single development program. Also consider device type and company size, because a startup's first design history file raises different questions than sustaining a large product portfolio.
Questions to take into the conversation
- 01How do you set up design control procedures that satisfy 21 CFR 820.30 and ISO 13485 without slowing development teams down?
- 02What makes design inputs and design reviews effective rather than paperwork exercises?
- 03How do you keep the design history file complete as a product moves from development through design changes after launch?
Reaching medical device design controls experts
How can I contact one of these medical device design controls experts?
Pick one of the 10 people on this page and choose "Book a paid call", or describe your project to find others. You offer a fee for a 15-minute call or a written answer, Instant Expert finds the person's work email and sends the invitation, and they decide whether to accept. The list covers 10 companies, including Teleflex, VB Spine and BD, based on profile data retrieved on October 4, 2026. Being listed here doesn't mean someone has agreed to take calls.
How much does it cost to reach medical device design controls experts?
You choose the offer, starting at $5 per person. It includes Instant Expert's 20% fee, so an offer that pays the person $100 costs you $125. You're charged only when the person books the call or sends the answer.
What if they don't reply?
You pay nothing. Instant Expert sends follow-up reminders, and if the person hasn't booked or answered within 7 days, the request expires and any hold on your card is released. You can invite several of the 10 people on this list at once and cap your total spend, so you pay only for the ones who accept.
About this directory
This is a professional research starting point based on business profile data retrieved on . Titles and companies reflect that source snapshot and may describe past or present roles. Check the linked profiles for current details. Inclusion does not imply Instant Expert membership or availability.
Request a correction or removal