Senior R&D Engineer Resume Franklin Lakes, New Jersey - Hire IT People

SUMMARY

I am a talented biomedical engineering professional with experience carrying a medical device through the design input stage to successful design verification and manufacturing ramp - up.
I have a broad range of skills, extensive product testing knowledge, and excellent attention to detail to allow timely and appropriate de-risking activities for a project.

TECHNICAL SKILLS

General Skills: 3D CAD / CAE, auditing, cGDP, cGMP, design for assembly/manufacturing, design verification, DoEs, electronics, environmental testing, ESD and EMC testing, GR&R, IEC 60601, ISO 11608, ISO 13485, IQ/OQ/PQ, materials characterization, mechanical testing and measurement systems, PM fiber optics, polymers, process and machine design, process improvement and control, programming, rheometry, silicones, spectroscopy, statistical analysis, technical documentation, test engineering and validation, website design

Software: ADINA, Bluehill 3, Caliber RM, CodeWarrior, Compliance Wire, Eclipse, LabVIEW, MasterControl, Mathcad, MATLAB, Microsoft Office (Excel / PowerPoint / Project / Visio / Word), Minitab, PSpice, Rational RequisitePro, Scientific Notebook, Simulink, Solidworks

Programming Languages: C, C++, HTML, Java, MATLAB

PROFESSIONAL EXPERIENCE

Confidential, Franklin Lakes, New Jersey

Senior R&D Engineer

Responsibilities:

Designed, improved, and validated test and assembly fixtures, including software and electronics.
Authored test instructions for test methods, assembly, and equipment usage.
Created data analysis templates and methods, using knowledge to plan and de-risk future testing.
Led root cause and tolerance loop analyses, modifying component design for improved performance.
Provided templates and assistance on design verification protocols.
Reviewed applicability of ISO 11608 and IEC 60601 to projects.
Held drawing reviews and updated drawings for simpler mold validation.

Confidential, King of Prussia, Pennsylvania

Product Development Engineer

Responsibilities:

Developed the system-level product requirements document, design verification plan, and risk trace matrices for a wearable auto-injector and led a successful design verification through the development phase design review.
Authored over 140 test methods, technical reports, analyses, audits, drawings, and design verification documents.
Relied on to edit reports and coach other engineers on cGDP, Caliber RM, design verification, test method validations, IBM ReqPro, Instron Bluehill software, and statistical analysis.
Designed tools and fixtures used both in R&D testing and in manufacturing.
Set up and conducted successful validations and design verification tests, interfacing with external suppliers when needed.
Undertook initiatives to increase internal testing capabilities, leading the purchase and implementation of testing equipment.
Received Emergo auditor training and conducted internal quality system audits.

Confidential, Somerville, New Jersey

Test Engineer

Responsibilities:

Evaluated synthetic tissue analogues for needle performance characterization and designed and validated mechanical test methods and measurement systems using GR&R studies with ISO and ASTM standards to set materials specifications.
Designed and implemented both mechanical and pneumatic needle coating machinery, needle coating processes, and test methods for characterizing coating performance and quality as well as their related work instructions, test protocols and documentation.
Developed novel suture needle coatings with significant cost advantage over current products, reduced cycle and cure times, extended pot and shelf life, and improved inter-lot consistency of needle penetration performance; improving initial penetration force by up to 23% and degradation by up to 221% over current production coatings.
Implemented process controls and improvements on production equipment, often working with external suppliers.

Confidential, Hackettstown, New Jersey

Fiber Optics Technologist

Responsibilities:

Developed and inspected standard and polarization maintaining multimode and single mode fiber optic components and devices, assisting in the development and streamlining of production and storage strategies.
Worked with engineering on functional specifications and detailed designs.
Functioned as a liaison between engineering, manufacturing, and administration.

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Senior R&d Engineer Resume

Franklin Lakes New, JerseY

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