Principal Engineer Customer Experience

Sergio Salinas

Cell: 1-650-***-**** — Menifee, CA - 92585 — ********@*****.***

SUMMARY

Competent, compassionate, and empathetic Principal Engineer/ Consultant with years of experience in the Medical Health industry. An accomplished delegator for responsibilities spanning operations supervision, operating tools, repair and maintenance, and prioritization. Works well under pressure with a persistent, determined, and goal-oriented outlook. Focused on embracing new career opportunities whereby my background and education are conducive to achieving goals and excelling with respect to the customer experience.

PROFESSIONAL SKILLS

• Operating Tool

• Complaint Handling

• Risk Assessment

• 3D Models and Blueprints

• Safety Procedures

• Catheters Design

• Engineering

• Management

• Project Leadership

• Inventory control

• CAD Solidworks

• Product Development

• Operations Supervision

• Repair and Maintenance

• NASA research and test center

• Safety regulations

• Project Development

• Design

• Documentation

• Imaging

• Material Management

• Endoscopy

• Manufacturing (contract management)

• Shipping/Receiving

EXPERIENCE

NATUS Neurology, Contract Menifee, CA

Sustaining Engineer Jan 2024 – Present

• Create ECO, DCO, Drawings, MPI, TP’s etc.. (Documentation).

• Investigate and solve engineering design problems

• Create and maintain design-related technical documentation for building a complete design history file

• Actively involved in selecting, sourcing, testing and approving materials to achieve specifications and reliability requirements

• Develop and implement a comprehensive engineering strategy to improve operational efficiency and reduce production costs

• Conduct research and analysis of engineering data

• Ensure implementation and approval of all aspects of Design Control including integrated design plan, design inputs, verification and validation according to corporate design control procedures S & A Design Solutions Menifee, CA

Principal Engineer/ Consultant Oct 2021 – Present

• 2 CLIENTS- Under S&A Design Solutions (Glannaventa), (WestFace Medical).

• Glannaventa (Serous Ovarian Cancer)- Developing outpatient imaging endoscopy to screen at- risk patients for the most lethal histocyte of serous ovarian cancer

• Westface Medical (Vascular Access)- Developing outpatient needle-integrated forward-facing optics imaging for vascular access.

• Creation of prototypes to provide design concepts for evaluation and proof of concept for MD’s, Investors

• Establish and maintain quality assurance standards for all engineering projects

• Investigate and solve engineering design problems

• Assist in the development of engineering project plans

• Track and report engineering project progress

• Develop and implement a comprehensive engineering strategy to improve operational efficiency and reduce production costs Simpson Interventions Inc. (Cardiovascular Coronary) Campbell, CA Principal Mechanical Engineer/Consultant Mar 2020 – Oct 2022

• Early-stage design/development of a Catheter for the crossing of Chronic Total Occlusions using a re-entry catheter with imaging to get back into the true lumen. Managed the lab and worked on prototypes to provide design concepts for evaluation.

• First Engineer hired to lead/manage the catheter handle, catheter and sled motor design.

• Prototype designs to provide design concepts for evaluation

• Participated in Animal studies as needed and necessary to evaluate designs.

• Design and produce fixtures necessary to approve and validate product for clinical use.

• Establish design and prototypes for evaluation.

• Created and released Solidworks drawings, test methods, and manufacturing process instructions.

• Communicate with vendors and suppliers to develop manufacturing processes, protocols, and requirements needed. Stryker (ENT-Ear/Nose/Throat division) Redwood City, CA Research And Development Engineer (R&D Engineer) May 2018 – Mar 2020

• After the Stryker acquisition, I was highly involved in the transfer and training of Stryker employees. Introduced the LATERA, an absorbable nasal implant and the delivery tool device. Managed the lab and worked on nasal implant prototypes to provide design concepts for evaluation

Entellus Medical (ENT-Ear/Nose/Throat) Redwood City, CA Research And Development Engineer (R&D Engineer) Jan 2017 – May 2018

• After the Entellus Medical acquisition, I was highly involved in the transfer and training of Entellus employees. Introduced the LATERA, an absorbable nasal implant and the delivery tool device. Managed the lab and worked on nasal implant prototypes to provide design concepts for evaluation.

Spirox, Inc (ENT-Ear/Nose/Throat) Redwood City, CA Research And Development Engineer (R&D Engineer) Aug 2015 – Jan 2017

• Spirox Inc., (Acquired by Entellus Medical)- Research and development of LATERA, an absorbable nasal implant and the delivery tool device. Managed the lab and worked on nasal implant prototypes to provide design concepts for evaluation. D3DC LLC (ENT-Ear/Nose/Throat) Menlo Park, CA

R&D Engineer/ Project Leader May 2012 – Aug 2015

• Oversee the research and development of multiple projects. Managed R&D lab, tools and equipment, which included writing reports for “out of tolerance” equipment, keeping track of equipment, and getting approvals to process the equipment through the Calibration system.

• Project I

• Provided services to company regarding matters relating to: methods and devices for tissue fastening implant and Delivery tool intended for rapid closure to surgically created wounds as an alternative to conventional suturing process. Participated/coordinated research and test studies at NASA Ames Research Center.

• Project II

• Provided services to company regarding matters relating to: methods and devices for the treatment of nasal valve collapse including bioresorbable implants and associated minimally invasive delivery tool TauTona Group (Theraputics) Menlo Park, CA

R&D Engineer Jun 2010 – May 2012

• About TauTona: Part venture capital fund, part R&D incubator – TauTona is a medical device firm committed to the development of disruptive technologies in key therapeutic areas. Gynesonics (Gynocology) Redwood City, CA

R&D Engineer Aug 2008 – Jun 2010

• Gynesonics is focused on providing an incision free option to women by treating symptomatic uterine fibroids.

• Currently the Gynesonics product has now obtained FDA Clearance to market the Sonata System Foxhollow Technologies (PAD Peripheral Artery Disease- Vascular) Redwood City, CA R&D Engineer Apr 2007 – Aug 2008

• FoxHollow developed minimally invasive devices for the removal of plaque for the treatment of peripheral artery disease. Constructed the first flow models for Physician demonstrations. Cytyc Surgical Products (Gynecology) Mountain View, CA R&D Engineer Mar 2006 – Apr 2007

• Design and development of Cytyc’s Gynecological Surgical Device and prepared it for clinical evaluation. The device included radio frequency tissue ablation energy. Was main designer of the injection molded handle. Took part in the composition and release of most of the documents prior to design reviews.

Cierra (PFO-Pulmonary Foramen Oval-Heart) Redwood City, CA R&D Engineer Aug 2003 – Mar 2006

• Design and development of the first catheter-based implant free device for Pulmonary Foramen Oval (PFO) closure. This is minimally invasive treatment of a heart valve condition. The device included radio frequency energy. Was highly involved in the shaft and handle development of the Cierra Device

Lumend Inc (Cardiovascular Coronary) Redwood City, CA R&D Engineering Specialist Jul 1998 – Aug 2003

• Early-stage design and development of the patented (Frontrunner Catheter for crossing of Chronic Total Occlusions) and (Outback a Re-entry Catheter to get back into the true lumen). Received two True Lumend Awards for the timely redesign of a handle and for the development amp; clinical build of several of Lumend’s catheters. Was highly involved in the shaft and handle development of the Frontrunner and Outback devices which included braided shaft technologies. (SEE patents below). Took part in the composition of test protocols and Manufacturing Process Instructions. Hands-on the fabrication of components in beginning stages using standard machining and braiding equipment.

Heartport Inc. (Cardiovascular) Redwood City, CA

Sr. R&D Engineering Technician May 1995 – Jul 1998

• Early-stage design for minimally invasive cardiac surgery. Received two Heartport employee recognition awards for outstanding performance and hard work. Was highly involved in the development of the shaft and balloon section of the Heartport Catheter. DVI- Devices for Vascular Interventions Inc (Cardiovascular Coronary) Redwood City, CA R&D Technician level 3 Jun 1990 – May 1995

• Early-stage design and development of (DVI’s main catheter for coronary atherectomy). Was involved in the development of the shaft and Polyester (PET) balloon section of the DVI Catheter. Hands-on the fabrication and lot release testing of the main product. Trained assemblers and technicians in first product builds and testing procedures. Was involved in the product transfer to its manufacturing facility in Temecula, Ca. DVI was acquired by Advanced Cardio Systems. EDUCATION

Certificate: # 100*********- Medication Technician Aug 2023 Elite Medical Academy

Certificate: # C64221DB3- BLS (Basic Life Support), CPR, AED, First Aid Jun 2023 Elite Medical Academy

License: #4281595 - Insurance Agent Producer Mar 2023 California Certified – Issued 3-21-2023

Certification: # BICSICECs-16 -Fiber Optics Jan 2022 Fis University

Certificate: Solidworks CAD Drawings May 2021

GoEngineering

Some College: Engineering Technologies Jan 2010

Penn Foster College Scottsdale, AZ

Some College: Mechanical Engineering Jan 2001

Mission College Santa Clara, CA

High School Diploma June 9th 1990

True Learning Center San Carlos, CA

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