Results-oriented Thermoforming Molding Program Manager with expertise in project management and design for manufacturability. Led product introductions that improved customer satisfaction and reduced costs through value analysis. Coordinated suppliers and directed cross-functional teams to achieve significant advancements in quality assurance and operational efficiency.
Overview
26
26
years of professional experience
3
3
Certifications
Work History
Thermoforming Molding Program Manager: New Product Introduction (NPI)
Wilbert Plastic Services
White Bear Lake, MN
04.2022 - 09.2025
IATF 16949 manufacture of plastic components and assemblies using heavy-gauge Thermoforming Molding for various industries. Website: wilbertplastics.com
Oversaw and managed the introduction of new programs from inception to production, ensuring alignment with customer needs.
The main point of contact for customers & vendors on project-related matters, providing updates and addressing all concerns.
Ensured new tooling met design standards and coordinated with suppliers for feedback on part, material, and tooling designs.
Conducted design for manufacturability (DFM) reviews to align customer product design with thermoforming processing, including solid model reviews and detailed redlines of specifications.
Provide project timelines and other reporting as needed using MS Project, PowerPoint, and Excel as appropriate.
Coordinate activities for Tools, Fixtures, Gauges, and equipment needed, including generating the purchase orders for them.
Lead Value Analysis/Value Engineering (VAVE) program to improve value proposition, reduce cost, and improve DFM.
Generate and update project balance sheet to monitor project budgets, taking corrective as needed to maintain profitability.
Support Production life cycle for design changes (ECO/DCO), including changes required process, tooling, cost impact, etc.
Generate and coordinate the Supplier Change Request (SCR) process with customers for products released into production.
Provide ongoing support to Production with CAPA activities, including meetings with customers and suppliers.
Present new best practices and technologies to Senior Manager and Operations for potential implementation into production.
Software used was MS Project, PowerPoint, Excel, MS Word, Outlook, IQMS, Agile, SharePoint, Google Drive, GEHC MWS.
Quality Assurance Engineering Manager – (Facility Executive Leadership Team Member)
Sanmina Corporation
Turtle Lake, WI
08.2021 - 03.2022
ISO9001, ISO13485 Full-service 28 to 1,000 Ton Plastic Injection Molding (Insert, Single & Multi-Shot, Over-Molding, In-Mold Labeling), and Assembly organization serving medical, consumer, electronics, computing, personal security systems, and phone care business. Website: sanmina.com/locations/turtle-lake/
Managed QA staff, including QA Supervisor, Receiving, In-process and Final Inspectors, QA Technicians, QA Resin Analyst, Calibration Specialist, Quality Engineers, and Data Analyst to ensure compliance with quality standards in Molding and Assembly operations.
Implemented cross-functional MRB process to improve processing and reduce recurrence of nonconformances.
Processed customer complaints, customer and vendor returns, CAPAs, and SCARs in Agile and Oracle.
Assist QA Management Representative in Customer and Registrar Assessments and Audits.
Reported key quality metrics internally and to Corporate, including OTD, DPPM, RMAs, NCMRs, and Customer Satisfaction, to provide insights for strategic decision-making.
Update and DCO QA Documents and review and approve Company documents in Agile.
Participates in the review of engineering designs to contribute quality requirements and considerations.
Supported product teams by gathering, analyzing, and reporting on internal and corporate quality data to drive continuous improvement initiatives.
QA Manager / ISO13485 Rep. (ELT Member)
I-Tek Medical Technologies
White Bear Lake, Minnesota
09.2018 - 07.2021
ISO13485/FDA Registered medical device, design, development, contract manufacturing company of medical device assemblies, sterile barrier packaging, sterilization management, 5 to 110 Ton Injection Molding (Micro, Insert, and Over-Molding), and metal machining. Website: i-tekmedical.com
Served as ELT member and ISO QMS representative, ensuring compliance with regulatory standards. Complaint, RMA, CAPA, SCAR, and NC process coordinator.
Review/Approve IQ, OQ, PQ, and Validation Protocols/Reports, Document Change Orders, Deviations, etc.
Conducted QMS review, calibration, pest control, environmental monitoring, internal audits, preventative maintenance compliance, customer/supplier/internal audits, and managed the online Learning Management System (LMS).
Collaborated with customers, suppliers, and staff to identify and implement product solutions.
Trained staff on best practices in technical and non-technical areas, enhancing overall team effectiveness.
28 to 350 Ton Plastic Injection Molder (Vertical, Clean Room, Insert, Over Molding) and assembler serving various industries. Website: tauruseningeering.net
Executed process changes that led to successful preparation and attainment of dual ISO9000 / ISO13485 certification.
Oversaw quality assurance operations, collaborated with customers and vendors, and trained production and quality teams.
Conducted process validations (IQ, OQ, PQ), first article inspections, capability studies, contract reviews, PPAP, FMEA, CAPA, ECO, calibration, data collection, inspection plans, operator instructions, control plans, supplier quality, device assembly program, inventory control, system, and IT.
Managed new business and transfer business programs, ensuring effective project delivery and alignment with corporate objectives.
Independent Sales Representative
I-Tek Medical Technologies
White Bear Lake, Minnesota
07.2008 - 03.2010
Established pricing, developed sales strategies, created call lists, and performed cold-calling to sell products to research and diagnostic laboratories, schools, colleges, and commercial scientific centers.
Specialized in selling blood and serum products while identifying opportunities to expand product offerings.
Developed and implemented vendor strategies to enhance growth, profitability, and customer satisfaction.
Manufacturing Manager, then Sales Account Manager for Enova Mfg. (now I-Tek)
I-Tek Medical Technologies
White Bear Lake, Minnesota
12.2006 - 06.2008
Managed Quality, Engineering, Production, Purchasing, and IT/IS as interim leader, reversing a failing contract manufacturing unit before returning to original sales role.
Increased profitability and customer loyalty by managing supply chain for device assembly business, coordinating with suppliers for plastic injection molding, EDM, machining, and various assembly processes.
Sr. Sales Account Manager
Synovis Interventional Solutions (IS)
Lino Lakes, MN
04.2003 - 11.2006
Multi-site ISO9000 medical device and contract manufacture, providing development, manufacturing, and assembly of wire forms, injection molding/micro-molding, machining, Swiss-screw, EDM, ablation, and joining methods in Class 10,000 clean rooms. Website: Not provided.
Integral part of aggressive revenue growth from $5 million to $30+ million in approximately 5 years.
Co-managed and implemented formal and informal lean manufacturing initiatives that enhanced operational efficiency.
Organized and hosted events for primary customer, representing company at trade shows to strengthen client relationships.
Consistently pursued and implemented a win/win process, product profit improvement opportunities.
Managed and grew multi-million, multi-site strategic account in the U.S. and Puerto Rico, and new accounts.
Achieved the highest quote/new business win rate, including a “multi-million-dollar entire business” bid.
Significantly improved R&D Quick-turn process, increasing lead times, profits, and new business pipeline.
Lead sales team and cross-functional teams on customer products and projects from cradle to grave.
Justified new process investments, developed sales forecasts, and optimized pricing to align with market demands.
Served as product and project manager for most respective customer opportunities.
Quality Manager – ISO 9001 QMS Representative (Division ELT Member)
Synovis Interventional Solutions (IS)
Lino Lakes, Minnesota
10.1999 - 03.2003
Management Quality System Representative and primary quality interface with customers and suppliers.
Lead complex disposition/reimbursement projects, recovering hundreds of thousands annually.
Managed reports for quality technicians and engineers across U.S. and Puerto Rico to ensure compliance with quality standards.
Participated in annual 5-year strategic planning and budgeting to ensure alignment of quality objectives with business goals.
Enhanced systems for DCO/ECO, RFC, RMA, NCR, CPAR, qualification, and calibration, improving overall quality management processes.
Managed product transfers, including bioburden, cytotoxin, and other testing requirements for customers.
Consistently tracked and implemented measures to reduce production scrap and Cost of Rejects (COR).
Education
Electronic and Engineering Technician Technology - Electronic And Engineering Technician Technology
ITT Technical Institute/Minnesota School of Business