Six plus years of R&D, NPD and Operational experience on Class II& III medical devices and Ten plus years of experience from Design and Manufacturing field.
Worked on a wide variety of medical product lines - Endovascular, Peripheral Vascular, Catheters, Stents, Pelvic Health and Occlusion products.
Extensive leadership experience in leading teams of highly skilled and diverse engineers.
Certified Six Sigma Green Belt & Solid Works Professional. Talented [Job Title] focused on process improvement and on-time delivery of all projects. Budgeting and forecasting specialist possessing advanced knowledge of [Software name]. Versatile [Job Title] dedicated to boosting company revenue through exceptional leadership and rigorous cost control techniques. Desires the opportunity to revamp processes and procedures and increase efficiency and product quality. [Job Title] offering expertise in process improvement, budgeting and forecasting. Exceptional leader who operates efficiently and creatively in fast-paced environments. Collaborative Project Manager emphasizing [Area of expertise]. Comprehensive background includes [Number] years in project planning and development. Trained extensively in [Area of training]. [Job Title] with [Number] years experience directing projects valued at $[Number] million to $[Number] million. Works well with people at all levels of the organization, including with stakeholders, customers and outside vendors. Motivated [Job Title] with more than [Number] years in project management in the [Industry name] industry. Offers an in-depth understanding of project lifecycles and project development methodologies. Exceptional Project Manager successful at directing change management initiatives requiring fast-paced execution. More than [Number] years in project management in a variety of industries. Self-motivated, innovative and goal-oriented management professional committed to [Areas of expertise]. Dedicated team player skilled at mediation and conflict resolution. Drives company growth by [Action]. Bilingual Project Manager with a passion for talent development and team building, as well as a strong background in finance. Comprehensive background includes [Number] years in the [Industry] industry.
Project planning and development
Six Sigma Certification
Advanced understanding of [Software name]
Fluent in [Language]
Advanced problem solving
Dedicated team player
Contract review and recommendations
Dedicated team player
Advanced problem solving
Project Manager01/2014 to Current American Medical System – MN
Leading a big team of engineers in the remediation project of Pelvic health Product line.
Managing Process Validation activities including Documentation of IQ, OQ, PQ activities, and Design Verification, Validation reports.
Managing Global labeling project using Easy label and Nice Label software.
Tracking the effort of project team members and ensure timely completion of project deliverables.
Reporting to Sr.
Vice President of this company.
Completed 68 IQ reports, 11PVMP, 4 TMV documents completed within 4 months.
Boosted company revenue by more than [Number]% by [Action taken].
Spearheaded [Initiative Name], resulting in [Positive result].
Directed all phases of [Project type] projects, from [Phase] to [Phase].
Drafted [Number] deliverables each [Time period] such as [Deliverable] and [Deliverable].
Developed [Number] executive presentations and reports to facilitate project evaluation and process improvement.
Directed planning, budgeting, vendor selection and quality assurance efforts.
Recommended process and systems improvements such as [Improvement description].
Supervised the work of [Number] team members, offering constructive feedback on their work performance.
Defined clear targets and objectives and communicated them to other team members.
Monitored timelines and flagged potential issues to be addressed.
Coordinated design meetings and decisions across [Number] internal departments and teams.
Reviewed sales, customer concerns and new opportunities to drive business strategy at weekly planning sessions.
Implemented a set of comprehensive tracking processes to monitor [Project name] performance.
Directed quality assurance efforts to maximize [Desired result] and minimize [Adverse effect].
Assessed vendor products and maintained positive vendor relations.
Collaborated with the [Department name] department to [Goal achieved].
Sr. Engineer07/2011 to 12/2013 Johnson & Johnson – CA
Managed Operations activities of 4 major product lines Endovascular Stent & Stent Graft Delivery system, Larger Lumen Guiding Catheter, PTA Dilatation Balloon catheter, Vascular Stent System to ensure timely launch of projects.
Successfully transferred product/ component design from R&D to production; Released design specifications, FAI reports (IR's), component management and equipment qualifications.
Worked with outside vendors for Creating and releasing Supplier Quality Agreement (SQA) and Supplier Qualification Strategy (SQS) documents.
Worked closely with marketing, Quality, Regulatory and designing team to develop, qualify and implement Product labels, Packaging parts, IFU, Implant card and Patient Brochures as per Internal, FDA and ISO design controls.
Complete knowledge on ISO 15223-1, ISO 13485 & 21CFR 820 Managed LCM project for 5 projects; DFMEA, Design Trace Matrix, hazard list and DVV protocol management and update.
Led Real Time aging (RTA) tests and prepared report for Design Verification & Validation (DVV).
Sr. Engineer09/2009 to 06/2011 Johnson & Johnson – NJ
Worked in R&D team of AAA-Endovascular Stent-Graft Delivery System.
Developed & Documented 6 new Test Methods (TM), TM Protocols, Validation and Validation reports.
Modified existing Test Methods and fixtures which resulted in a savings of approx.
Designed, Developed and Qualified test fixtures on tight timelines.
Analyzed test result (Minitab) and helped in developing IDE submission dossier.
Complete knowledge on ISO 25539-1.
Engineer05/2008 to 09/2009 Boston Scientific – Chennai,
Worked in NPD team for a complex Class III medical device project which comprises of about 450 mechanical components and around 250 electrical components.
Created 120 plus 3D CAD model & 2D drawings and released the same through Agile PLM System Created and released the assembly work instructions in less than 3 months for the entire device.
Lead the manufacturing Operations and Integration activities for the final assembly of the device.
Completed Structural analysis study and experiments to meet IEC 60601-1 Regulatory and Safety Standard.
Completed Thermal analysis study and verified through actual testing.
Enhanced the device packaging and released the drawings in Agile PLM system.
Bachelor of Technology: Mechanical Engineering1 2008Jawaharlal Nehru Technological University
- Mechanical Engineering
Post Diploma: Tool Design1 2003Central institute of Tool Design
- Tool Design
Diploma: Tool Engineering1 1998Institute of Tool Engineering
AWARDS: J&J Award (Cordis, J&J) Extraordinary project contributions resulted in timely launching of Stent Delivery System. Star Certificate of Excellence Award (Cordis, J&J) Improvements in incoming process resulted in $113k of savings. Extra Miler Award (Cordis, J&J) Education and Mentoring of offshore engineers resulted in considerable project time saving. 1st Place Team Award" - Cordis (J&J) Won 1st place in "Innovative Medical Device Design" Contest.