VARUN MANNE
Little Canada
Summary
Senior Manufacturing engineer with 6+ years in medical device operations (Abbott and Tier‑1 suppliers). Driven production support, validation (IQ/OQ/PQ), process optimization, and quality compliance under FDA 21 CFR 820, ISO 13485/14971. Known for data‑driven problem solving (DMAIC/A3), yield and uptime improvements, and cross‑functional leadership with Quality, Operations, and Suppliers. Experienced training operators/technicians and mentoring early‑career engineers; partner closely with Product Development for DFM/fixtures to support launch and ramp plans.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Manufacturing Engineer
Abbott
St. Paul, Minnesota
08.2021 - Current
- Provide daily production support across catheter manufacturing areas, including troubleshooting processes/equipment, coordinating with Quality Engineering, and ensuring documentation, calibration, and training remain compliant.
- Trained and led two new engineers to complete a FlexNav component improvement project, delivering on-time execution and supporting commercial line readiness.
- Lead continuous improvement initiatives to drive yield, cycle time, and throughput improvements using DMAIC/A3, SPC, DOE, and Gage R&R.
- Manage full validation lifecycle (IQ/OQ/PQ) for new equipment and process updates, including protocol development, execution, analysis, and reporting.
- Support equipment implementation projects (scheduling, procurement, site prep, installation qualification) and develop long‑ and short‑range plans to improve efficiency, fixture design, and process capability.
- Partner with R&D/Process Development through SDDP to implement DFM improvements, fixture redesigns, and assembly robustness for current and next‑generation SH products.
- Train operators and manufacturing technicians on revised processes and WIs; developed structured training plans to support ramp stabilization and consistent outputs across shifts.
- Lead and support Kaizen activities focused on space optimization, line balancing, and sustaining one-piece-flow initiatives.
- Interface with vendors for incoming components and manage SCR updates and validation.
- Investigate and close CAPAs and complaint records, delivering sustainable corrective actions and multiple verified CAPA closures (Abbott CAPA certified).
- Utilize electronic data collection systems and statistical tools to monitor process performance, reduce variation, and maintain control plans aligned with QSR and ISO 13485.
- Mentored an engineering intern through a CI project, achieving a 100% increase in equipment capacity and on-time project delivery.
Manufacturing Engineer
L&T Technology Services (Client Phillips Medisize)
Hudson, Wisconsin
01.2020 - 08.2021
- Planned and executed of Change assessment plan to develop protocols, Equipment transfers, SAT, VMP strategies as per ISO 13485 regulation.
- Conducted production planning, operator training, and WI rollouts while implementing process improvements that reduced scrap and increased productivity.
- Worked on RMA of spares, getting spares ordered on time and preparing weekly reports through SAP ERP system.
- Support line issues and troubleshooting machinery line controls to fix issues and support 5S & spare part management.
- Led CI and Lean Six Sigma projects, designed prototypes, jigs, and fixtures to improve safety and productivity.
- SAP data records generation for new engineering records, quality management notifications, inspection records, spares, certification, and documentation.
- Supervising strategies involving validation (IQ, OQ, PQ), quality testing, defect management, cpk, ppk analysis.
- Identifying validation and production issues and resolving routing quality notifications, initializing RCA, FMEA.
- Evaluating training protocols and safety guidelines for efficient PPC and maintaining 6S in the work arena.
- Conducted product quality test runs in multiple phases to check the product, fill, package, and seal integrity checks. Review and modify Design Validation /Specifications /documents /Drawings / DHF/MDR.
Manufacturing Process Engineer
Tekwissen LLC (Client Thermo Fisher Scientific)
Millersburg, Pennsylvania
09.2019 - 01.2020
- Providing technical engineering support to Production, Laboratory, and Maintenance required for production process changes in support of new and existing equipment /processes in a Sterile manufacturing facility w.r.t ISO 13485, 21CFR820.
- Supporting User technical transfers (URS), modifications to existing processes, adding new processes that will improve process safety by risk-based approach ISO 14971.
- Equipment procurement and calibrating HMI data through SAT, FAT, IQ, OQ, PQ and documentation.
- Supporting QC teams for NC management and engineering FMEA, Root cause data analysis.
- Providing planning support to reduce plant operational costs as well as improve product quality and efficiency.
- Conducted capacity studies, enhanced system reliability, and identified product improvements.
Manufacturing Design Engineer
Logging-In
Canton, Michigan
02.2019 - 08.2019
- Worked with cross-functioning teams from offshore on design projects on fixtures using CAD.
- Experienced in DFMEA, Proficient in hand tools, Handled and managed multiple projects, tasks and a team player.
- Worked cross functionally to resolve product and component issues.
- Collaborated directly with suppliers, leading supplier meetings, reviewing data, compiling reports, Defined, and evaluated customer SOP.
Graduate Research Assistant
Texas A&M University-Kingsville
Kingsville, Texas
12.2016 - 12.2018
- Conducted complex mechanical analysis using ANSYS for turbine design optimization.
- Performed FEA meshing studies and validated simulation results with a 3D‑printed prototype.
Education
MS - Mechanical Engineering
Texas A&M University – Kingsville
Kingsville, Texas12.2018
BE - Mechanical Engineering
SCSVMV University
05.2016
Skills
- Leadership & Operations: Front‑Line Support , Cross‑Shift Coordination, Training & Development, Project Leadership
- Process Excellence: DMAIC/A3, Lean/Kaizen, SPC/DOE, Gage R&R, PFMEA/DFMEA, Risk Management
- Validation & Quality: IQ/OQ/PQ, CAPA/NC, ISO 13485/14971, DHF/MDR, Complaint Investigations
- Technical Expertise: Equipment Implementation, DFM, Fixtures, One‑Piece Flow, SAP ERP, Data Collection Systems
Certification
- Certified [Job Title], [Company Name] - [Timeframe]
Publications
Designing and Analyzing Savonius Wind Turbines, ASME International Mechanical Engineering Congress and Exposition, 2019-11-14, https://asmedigitalcollection.asme.org/IMECE/proceedings-abstract/IMECE2019/59414/V004T05A014/1073083
Timeline
Manufacturing Engineer
Abbott
08.2021 - Current
Manufacturing Engineer
L&T Technology Services (Client Phillips Medisize)
01.2020 - 08.2021
Manufacturing Process Engineer
Tekwissen LLC (Client Thermo Fisher Scientific)
09.2019 - 01.2020
Manufacturing Design Engineer
Logging-In
02.2019 - 08.2019
Graduate Research Assistant
Texas A&M University-Kingsville
12.2016 - 12.2018
BE - Mechanical Engineering
SCSVMV University
MS - Mechanical Engineering
Texas A&M University – Kingsville