Risk Management
Current
Apr 2023 - Present
AeroLeads people directory · profile
Daniel Delgadillo Email & Phone Number
Talented Principal Medical Device Quality Engineer
at
GRAIL
1 work email found
@stryker.com
LinkedIn matched
✓ Verified May 2026
4 data sources
Profile completeness 100%
Current company
Role
Talented Principal Medical Device Quality Engineer
Location
New York City Metropolitan Area, United States, United States
Who is Daniel Delgadillo? Overview
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Quick answer
Daniel Delgadillo is listed as Talented Principal Medical Device Quality Engineer at GRAIL, based in New York City Metropolitan Area, United States, United States. AeroLeads shows a work email signal at stryker.com and a matched LinkedIn profile for Daniel Delgadillo.
Daniel Delgadillo previously worked as Risk Management at Grail and Risk Management Lead at Alku. Daniel Delgadillo holds Bachelor Of Science, Mechanical Engineering from Polytechnic University Of Nyu.
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Email format at GRAIL
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{first}.{last}@stryker.com
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Profile bio
About Daniel Delgadillo
A driven and passionate life-long learner, I constantly seek to understand the quickly changing landscape of medical device quality, risk management, and regulatory changes. I am in my element when I am analyzing these changes and develop creative, innovative approaches to implement compliance in a way that fosters and grows new product development efforts. With over 10+ years in the industry, I have a broad and deep understanding of the challenges facing medical device companies. My experience spans new product development, DHF and risk remediation management, FDA and EU MDR submissions, and all aspects of quality engineering. Articulate and engaging throughout my communication, I coordinate with staff and interface with cross-functional leaders to discuss project needs and develop strategic, targeted plans. With a servant-leader management style, I enable my team of talented quality engineers to rapidly drive process improvements, achieve the highest level of quality for new products, and reach key deadlines at or before critical delivery dates. - Design Quality- Risk Management- Usability and Human Factors- Design Verification and Validation- Med Device Systems Engineering- Design Controls- EU MDR Remediation- 510k and Special 510k- EU MDR Submissions- MDSAP- Gap Assessments/Audit Preparedness- QMS/Process Improvement- Acquisition Integration- Regulatory Audit Responses- CAPA Board- Post-Market Risk Management
Listed skills include Microsoft Office, Autocad, Microsoft Word, Powerpoint, and 21 others.
Current workplace
Daniel Delgadillo's current company
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11 roles · 9 years
Daniel Delgadillo work experience
A career timeline built from the work history available for this profile.
Risk Management Lead
CurrentSupport clients with Risk Management activities with a focus on EU MDR and 14971:2019 remediation.
Nov 2022 - Present
Senior Risk Management Design Quality Engineer
Served as the leader of Risk Management process owner for all 14971/13485 medical devices and IVDs at Invitae, Boulder and guided teams through risk management related 510k deficiency responses for denovo submissions.- Responsible for overhauling the existing risk management process; ensuring process compliance to applicable standards and regulations.
Oct 2021 - Oct 2022
Staff Quality Engineer New Product Development
- Guided four simultaneous projects through different product design stages from conception to launch as the only quality resource. Developed all four risk management files from the ground up.- Ensured all design choices were informed by ISO 62366 for usability optimization and all new products were compliant with REACH regulations.- Ensure the successful.
Apr 2019 - Oct 2021
Eu Mdr Remediation Technical Lead And Project Manager
- Lead a team of 9 engineers to project to remediate existing risk management and technical files for EU MDR while integrating an acquisition company’s risk files into Stryker QMS.- Assess structure across parent and acquisition site’s existing risk management files, technical documentation, and CERs and suggest, review, and implement process improvements.
Jan 2018 - Oct 2021
Risk Process Owner
- Serve as Risk Management divisional lead, ensuring compliance to applicable standards and regulations, including ISO 14971:2019 and EU Medical Device Regulation (MDR), and leading the integration of risk management processes for the K2M acquisition.- Partner with the Executive Leadership Team in creating a culture of quality and compliance.- Lead quality.
2017 - Oct 2021
Change Control And Capa Board Member
- Perform Nonconformance (NC) and Corrective and Preventative Action (CAPA) activities using TrackWise software (including root cause analysis, severity, and Post Market Health Risk Assessments [PMHRA]).- Serve as a voting member of the Change Control Board responsible for QA approval and resource allocations to ensure on-time completions for all priority.
Jan 2014 - Oct 2021
Senior Advanced Quality Engineer
Mar 2017 - Apr 2019
Advanced Quality Engineer
Jan 2014 - Mar 2017
Associate Engineer
General Bearing Corp
- Managed and maintained the Returned Goods Authorization process for the customer issues database. This system involves the cooperation of all company departments to respond effectively to customer issues with the product: shipping errors, quality (manufacturing defects, field investigations), and testing of new products.- Applied training in Six Sigma to.
Apr 2011 - Apr 2013
Engineer
Lucius Pitkin Inc
Assisted in performance of field engineering failure investigations by traveling with engineers to customer sites and performing measurements, photographing, data collection and analysis.
May 2008 - Apr 2011
1 education record
Daniel Delgadillo education
-
Polytechnic University Of Nyu
FAQ
Frequently asked questions about Daniel Delgadillo
Quick answers generated from the profile data available on this page.
What company does Daniel Delgadillo work for?
Daniel Delgadillo works for GRAIL.
What is Daniel Delgadillo's role at GRAIL?
Daniel Delgadillo is listed as Talented Principal Medical Device Quality Engineer at GRAIL.
What is Daniel Delgadillo's email address?
AeroLeads has found 1 work email signal at @stryker.com for Daniel Delgadillo at GRAIL.
Where is Daniel Delgadillo based?
Daniel Delgadillo is based in New York City Metropolitan Area, United States, United States while working with GRAIL.
What companies has Daniel Delgadillo worked for?
Daniel Delgadillo has worked for Grail, Alku, Invitae, Stryker, and General Bearing Corp.
How can I contact Daniel Delgadillo?
You can use AeroLeads to view verified contact signals for Daniel Delgadillo at GRAIL, including work email, phone, and LinkedIn data when available.
What schools did Daniel Delgadillo attend?
Daniel Delgadillo holds Bachelor Of Science, Mechanical Engineering from Polytechnic University Of Nyu.
What skills is Daniel Delgadillo known for?
Daniel Delgadillo is listed with skills including Microsoft Office, Autocad, Microsoft Word, Powerpoint, Windows, Engineering, Risk Management, and Change Control.
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