MICHAEL PINTO
Abbott
Maple Grove,MN
24
years of professional experience
Knowledgeable [Desired Position] with solid background in manufacturing engineering supervision and proven record of leading production teams to meet operational goals. Successfully implemented process improvements that enhanced productivity and reduced downtime. Demonstrated excellence in problem-solving and team leadership.
Work History
Sr. Mfg. Engineering Supervisor, Structural Heart
8 Months- Provide technical mentorship and leadership to engineers and technicians on Nitinol braiding, laser cutting & welding and forming of semi-finished devices.
- Coordinate the design, procurement, build and debug of tooling, machinery and test equipment for delivery systems processes.
- Lead CAPA investigation on audit findings of undocumented fixtures for investigative and resolution phases.
- Supervisor 5 ME Technicians coaching their development, workload balance and PM strategies.
- Established Maintenance Benchmarking on DT response, PMs and critical spare metrics for department.
- 75% scrap reduction in catheter loader plasma treatment process by RCA methodology.
- Establish KPI metrics for MTBF and MTTR with associated Power BI dashboard for Tier reporting.
- Created and trained maintenance and production teams for DT communication and response system.
- Established WO standard execution, review and closure process.
- Lead CAPA team for braiding software updates and associated qualification protocols.
Mfg. Engineering Supervisor
5 Years 9 Months- Managed the responsibilities, development, project workload, and day to day activities of 6 engineers and 12 technicians.
- Supported transfer of 10 equipment (balloon catheter folders, packaging unit, and boxing/cartooning units) to Penang, MY and El Dorado, PR sites over 9 months.
- Managed scrap budget and created model to reduce scrap through quick win projects, 1st 6months, saved $75K in scrap.
- Implemented downtime response process aid for technician prioritization. Response time reduction of ~6min/response.
- Oversaw department VIP entries and management report out. Increase VIP output $235K/yr.
- Line support engineer to 4 extrusion lines (Multi-lumen, Co-extrusion, free and over substrate extrusion) and mentor to junior engineers in day-to-day activities.
- Total process improvements across extrusion lines for 2025; ~$750K, (Labor, scrap and process optimization).
- Designed and executed DOE studies to characterize silicone extrusion process through statistical analysis (CpK/PpK methods).
- Expanded ranges of mfg parameters of silicone extrusion process to increase output by 15%.
- Identified opportunities to reduce labor, materials and time for extrusion process through gap analysis.
- Increased silicone extrusion output by ~15% by equipment and process optimization.
- Supported quality investigations; critical scrap resolution, customer communications, supplier chain updates, and non-conformance events.
- Redesigned extrusion tooling for optimization of extrudate flow within tooling chamber to reduce tip wear. Extended tip life by 2months and saved ~$3750/yr on tips.
- Successfully contribute to business goals and product support, by utilizing tools such as process capability studies, process development, Six Sigma and Value Improvement projects, report preparation and process/test documentation.
- Complete and manage Capital Expenditure Request and Authorizations (CERA’s) for Balloon coating machine ($1.7MM) and PI coating and inspection machine ($1.2MM).
Sr. Manufacturing Specialist
1 Year- Production support of day-to-day purification and aseptic filling by managing material request, batch documentation, BOM generation and change controls – min 3 customer batches per day.
- Introduced material logistics program (KanBan) for purification and support operations. Reduced emergency requests and incorrect ordering by ~40%.
- Collaborate with customer to facilitate production process and release requirements for purified bulk product.
- People leader for Buffer prep operations of 9 operators across two shifts.
- Managed day to day activities, staffing, training of work instructions, batch and material planning.
- Monitored scrap and labor utilization by using pareto, run charts and statistical methodologies to identify top 3 items to address weekly.
- Lead activities associated with production process and equipment ownership including: Batch Record Generation, Process Improvements, Training, CAPA Ownership and Implementation, Equipment Upgrades and Maintenance Scheduling, work requests.
- Support activities associated with production support including: Document Issuance Requests, Materials Requests, Scheduling, Executed Record Tracking, BOM Updates in ERP.
Sr. Process Engineer
3 Years 8 Months- Supported Bevespi Aerosphere process technology transfer to international AstraZeneca and CMO production sites.
- Managed validation and qualification process to implement Bevespi into commercial production.
- Authored and presented manufacturing sections for regulatory submission of NDA, to US, EU and RoW markets.
- Modeled complex algorithms for propellant additions during batch filling operations.
- Managed characterization studies to design crimp pressure for container closure and integrity testing.
- Managed production of clinical materials for Phase II and Phase III trials for NDA submission.
- Supported commercial batch process optimization using statistical analysis (CpK/PpK methods).
- Supported Process Development activities for Bevespi Aerosphere and next generation products.
- Generated batch reports, site to site comparison risk matrix, risk assessments (process improvements and equipment introductions), Process FMEA.
- Designed and executed scale-up studies and DOE characterization studies for formulation filling process.
Manufacturing Specialist
2 Years 2 Months- Supported the site-to-site tech transfer of MMR, Zostavax, VIII for US and EU production to Durham site.
- Performed process gap analysis with sister MMR production site at West Point, PA to identify 6 studies to be conducted to demonstrate equivalency for validation.
- Assisted in equipment qualification and validation of bulk pooling and vial sorting equipment and process.
- Supported downstream Vaccine manufacturing commercial production.
- Assisted in validation of fill finish productions of lyophilized vials to bulk packaging including visual inspection system.
- Line support to manufacturing volumes and product response. Utilized basic problem solving to identify root cause.
- Attained Six Sigma green belt certification.
Process Engineer and other engineering roles
8 Years 6 Months- Led process development activities of Contact Lens multi-purpose solution formulation.
- Executed characterization studies to define operating design space.
- Designed and executed scale-up studies for clinical and commercial batch sizes.
- Qualified and validated Process Analytical Technology (Particle Camera Analyzer) into commercial production.
- Authored protocols, test recording sheets, technical memos and reports.
- Pilot plant engineering support of lens fabrication lines.
- Reduction of internal pilot plant production time by 20% by harmonization of cross functional groups.
- Led investigations in contact lens pilot plant activities to address gaps in production execution.
- Documentation of work instructions, technical reports, batch records, and memos, and project updates.
- Supported activities for optimization of concentration filtration TFF system and disposable bioreactor systems.
- Managed a maximum of 12 employees with day-to-day activities, development, and training curriculum.
- Authored, revised, and reviewed work instructions for commercial production.
- Collaborated with QA to reduce batch record review from 5 to 2 days by identifying time gaps and redirection of resources.
Manufacturing, Operator
1 Year 1 Month- Manufactured research grade E. coli plasmid per batch record requirements.
- Created and updated batch records per customer requirements.
Education
M.S. - Chemical Engineering
B.S. - Chemical Engineering
Skills
Engineering documentation
Cross-functional team leadership
Cost reduction strategies
Statistical process control
Maintenance planning
Staff supervision
Process improvement
Manufacturing processes
Process development
Design and manufacturing reviews
Engineering concepts
Teamwork and collaboration
Excellent communication
Planning and scheduling
Timeline
Sr. Mfg. Engineering Supervisor, Structural Heart
Abbott
10.2025 - CurrentRead More
Mfg. Engineering Supervisor
Boston Scientific Corporation
11.2019 - 08.2025Read More
Sr. Manufacturing Specialist
KBI Biopharma
10.2018 - 10.2019Read More
Sr. Process Engineer
Pearl Therapeutics – An AstraZeneca Company
12.2014 - 08.2018Read More
Manufacturing Specialist
Merck, Sharpe, & Dohm
10.2012 - 12.2014Read More
Process Engineer and other engineering roles
Johnson and Johnson
03.2004 - 09.2012Read More
Manufacturing, Operator
Puresyn Inc.
02.2002 - 03.2003Read More
Rensselaer Polytechnic Institute
B.S. from Chemical Engineering
Read More
Villanova University
M.S. from Chemical Engineering
Read More