Sri M
Operations | Product Manager | R&D | GMP | Manufacturing | Medical Devices | Commercialization | Scalability | Product Launch | Product Testing | NPD | 510(K) submissions | IoT | FDA QSR
- Role
- Product Manager at Doseoptics Llc
- Location
- Norristown, PA, US
- LinkedIn followers
- 500 followers
About Sri M
Collaborate with Leadership team to establish strategic plans and objectives for product launch (0-1), sustainability, product development, Supply chain management, manufacturing and budgeting. • Direct and oversee R&D projects and budgets utilizing both internal resources and external suppliers • Provide leadership and direction to NPI Operations in development & product launch for innovative new medical devices including implementation of GMP manufacturing best practices and GDP • Hands-on experience with Product packaging, Packaging testing, Medical Device Class II Product Testing (EMC/ ESD / Emissions), Risk mitigations and Root Cause Analysis. • Design of Experiments (DOE), Bill of Materials (BOM), Cost of Goods Manufacturing (COGM), Manufacturing Work Instructions (MWI), Engineering Change Order (ECO), FDA QSR, QMS, PFMEA, 21 CFR part 820, CAPA, NCMR, Compliance for ISO 13485, ISO 14971. • Ensure timely and high-quality documentation of DHFs, DMRs, and DHRs for each project according to the company’s quality policy and regulatory bodies • Capital Equipment Projects (Auto Disable Syringes) worth $3M, IoT electromechanical devices, Project Management, R&D, Ambulatory ECG device prototyping, Continuous Glucose Monitor, and Insulin Pump proof of concepts.
Experience
Product Manager
Mar 2022 — Present · Lebanon, NH, US
Education
KL University
Bachelor's degree
2009 — 2013
The University of Texas at Arlington - Fort Worth Campus
Master's degree
2016 — 2018
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