Program Manager Resume Indianapolis, IN - Hire IT People

EXPERIENCE

Confidential, Indianapolis, IN. A leading developer, manufacturer and distributor of innovative interventional breast products dedicated to improving the lives of women.

Program Manager, Confidential, Mar. 2011 to present

Senior engineer for a market leading handheld disposable breast biopsy product line.
Collaborate with all business departments and senior management to align program direction.
Establish and maintain a cross functional priority list and drive accountability for deliverables.
Leader of a seven member cross functional team to complete new product and sustaining projects.
Conducted a root cause analysis for an injection molded failure and implemented a solution.
Executed a successful feasibility evaluation of a new product design based on customer feedback.
Analyze physician feedback against failure modes to determine trends and initiate changes.
Develop testing plans, manage verification activities and author design history file documents.
Ensure products are complaint to ISO 13485, CFR 21 part 820 and GMP requirements.

Program Manager, Confidential, Oct. 2007 to Mar. 2011

Fulfilled dual roles as a product development engineer and a program manager for a line of implantable breast biopsy markers and delivery devices.
Designed and launched an innovative marker solution for optimized X-ray and MRI visualization.
Developed three disposable products through concept development, the design control process, transfer to manufacturing, ramp up for production and successful implementation in the field.
Obtained working knowledge of ISO10993 biocompatibility testing standards for implants.
Engaged physicians through user preference studies to obtain valuable feedback on devices.
Established verifiable product requirements based on internal and external input.
Managed project to establish and launch a contract manufactured implant and delivery device.
6 issued US patents: 7761137, 7996065, 8062230, D625005, D643118 and D641471.

Product Development Engineer Apr. 2005 to Oct. 2007

Executed development projects to expand an implantable breast biopsy marker product line.
Conceptualized, designed, verified, validated and launched two marker delivery systems.
Developed a unique marker deployment device that was successfully adopted by the market.
Generated all engineering specifications and created rapid prototypes to evaluate designs.
Managed all design control activities to ensure regulatory compliance of the design history file.
Established and controlled risk management documentation including the DFMEA.
Created protocols, executed tests and authored reports within FDA and ISO regulations.
Co-authored, submitted and obtained 510(k) approval for a breast biopsy marker device.

Confidential, Indianapolis, IN.
Engineering Designer Jan. 2004 to Apr. 2005

Led project to develop and launch the company's first implantable class II breast biopsy marker.
Designed all components including hypodermic tubing, injection molded parts, machined parts, joints, compression springs and titanium implants using SolidWorks CAD software.
Collaborated with suppliers to optimize component design for manufacturability.

Confidential, Howe, IN.
Engineering Designer Jan. 2003 to Jan. 2004

Acquired experience in the product development process including concept definition, prototyping, drawing specifications, revision control, assembly modeling and tooling design.
Developed proficiency modeling and creating drawings in SolidWorks CAD software.

EDUCATION

Bachelor of Science, Engineering Computer Graphics Technology

ADDITIONAL

Current board member of a water ski organization focused on promoting the sport.

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Program Manager Resume

Indianapolis, IN

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