Program Manager Resume Example Transenterix Inc

PROGRAM MANAGER

Profile

Experienced Program Manager with over 10 years expertise in product development, systems engineering and Verification and Validation testing. Strong communication, interpersonal and relationship-building skills with surgeons, internal customers, and team members.

Areas of Expertise

Engineering

Electromechanical design and testing, System level engineering analysis, Control systems, Kinematics, Static and dynamic analysis, GD&T

Regulatory

ISO 14971 Risk Management for medical devices, ISO 62304, IEC 60601-1 third edition collateral and particular standards, Successful 510K submissions, GLP Validations

Quality

IQ/OQ/PQ, Statistical analysis, Application and Design FMEA, technical writing, V&V Protocol Development, GR&R

Management / Leadership

Strong commitment to team environment dynamics, Excellent written and verbal communication skills, Empathic listener and persuasive speaker

Professional Experience

Program Manager05/2013 to CurrentTransenterix Inc

Managed verification and validation efforts for the SurgiBot robotic platform, delivering best-in-class robotic-assisted, minimally invasive laparoscopic surgery.
Led multi-disciplined team including R&D, Quality Assurance and Marketing & Operations to deliver next generation product development with improved precision, clinical safety, and efficiency, and surgeon satisfaction.
Improved existing requirements management traceability processes including top-level marketing inputs through design level requirements.
Identified risk mitigation strategies to ensure patient and operator safety through focused engineering efforts.
Developed SurgiBot testing plans and schedules ensuring successful project completion in less than 1 year.
Developed System level acceptance criteria and rationales for core surgical tasks.

Senior Application Engineer01/2012 to 05/2013Transenterix Inc

Expanded mechanical and electrical testing capabilities with a focus on ensuring successful product launch
Developed over 100 test procedures during prototype verification testing
Familiarization with general laparoscopic abdominal surgical procedures including Gastric sleeves, Cholecystectomy, Gastric Bypass, Nephrectomy and Hysterectomy
Responsible for developing clinical and product performance requirements and specifications helping drive prototype development efforts Develop, implement, and document product testing protocols and procedures to meet regulatory testing requirements related to IEC 60601-1 3rd Edition basic safety and essential performance.
Led successful 510K premarket approval for novel class of monopolar electrosurgical laparoscopic instruments.
Identify requirements and perform risk assessments (FMEA) for robotic system.
Assist manufacturing in gathering and analyzing data to improve process and product quality.

Senior Systems Engineer11/2007 to 08/2011SPARTA, Inc.

Led the integration, testing and evaluation of the first and only operational biological and chemical detect-to-protect system as part of the Pentagon Shield CBRN Protection Program.
As lead project engineer, was responsible for the capabilities analysis, commercialization of sensor technology to industry, implementation plans and ensuing technical support efforts.
Managed and coordinated efforts of a multi-disciplined task force of engineering specialists, governmental, military and contract personnel during integration and system enhancement process.
Demonstrated first and only operational CBRN detect-to-protect system at the Pentagon, while reducing system level false alarm rates by over 90%.
Technical writer and advisor on Scientific, Engineering and Technical Assistance [SETA] proposal generating over $3M in contracts awarded by the Department of Defense [DoD].
Develop Standard Operating Procedures [SOPs] and Concept of Operations [CONOPs] used by the PFPA Integrated Emergency Operations Center [IEOC].
Training of CBRNE first responders, IEOC and O&M contractors on the proper operation and maintenance of Pentagon Shield sensor systems.

Associate Research Scientist08/2001 to 11/2007MIT Lincoln Labs

Chosen as lead project engineer for the design, fabrication and functional testing of an advanced optoelectronic cellular-based biosensor for the Defense Advanced Research Projects Agency [DARPA], successfully completed within $600K budget and one-year timeframe.
After completing the prototype fabrication, executed live-agent testing at Dugway Proving Ground and Edgewood Chemical Biological Center [ECBC] BL3 facilities.

Education

M.S: Biomedical EngineeringBoston University

Biomedical Engineering

B.S: Mechanical EngineeringVirginia Polytechnic Institute and State University

Mechanical Engineering

Skills

Matlab, Simulink, Labview, Minitab, DOORS and Cognition requirements management software, Mechanical design, MTS and Instron Tensile Tester Systems, Solidworks, Optical Microscopy, Opto-electronics, Scanning Electron Microscopy, RT-PCR, Biological Assays, ELISA

Resume Overview

Companies Worked For:

Transenterix Inc
SPARTA, Inc.
MIT Lincoln Labs

School Attended

Boston University
Virginia Polytechnic Institute and State University

Job Titles Held:

Program Manager
Senior Application Engineer
Senior Systems Engineer
Associate Research Scientist

Degrees

M.S : Biomedical Engineering
B.S : Mechanical Engineering

Program Manager Resume Example

Resume Score: 90%

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