SUMMARY

• Versatile and analytical project manager and engineering leader who possesses a proven track record in product design and development, strategic project planning, quality/reliability, team motivation, supply chain management, and launching products to the market.
• Results driven leader with proven aptitude for analyzing and continuously improve products and business procedures.
• Leads core teams to create innovative world - class quality products, meet schedules and customer needs, develop lean repeatable manufacturing processes, and reduce development and operating costs.
• Promotes importance of cross-functional team collaboration and effective utilization of time and resources to achieve goals.

AREAS OF EXPERTISE

• Project Leadership & Decision Making
• Planning, Scheduling & Prioritization
• Product and Process - Design & Improvement
• New Product Verification, Testing and Launch
• Process and Test Method Validation
• Cross-Functional Alignment & Team Mentoring
• Product Roadmaps - Sales & Marketing Proposals
• Supply Chain Management & Vendor Selection
• Customer Service, Relationships, Communication
• Off-shore Coordination & Communication

TECHNICAL SKILLS

• Microsoft Office Suite & Project
• SharePoint
• Oracle

PROFESSIONAL EXPERIENCE

Confidential, Minneapolis, Minnesota

Program Manager II

Responsibilities:

• Contract program management and product remediation (483) coordination at Boston Scientifics Male Urological and Pelvic Health division, Minnetonka MN location.
• Core team leader for design and manufacturing process implantable prosthetic component remediation and test method validation including; protocols, execution, reports and rework.
• This included all silicone and plastic molded components, extruded tubing, and anti-microbial and lubricity coating work-streams.
• Core team leader for remediated manufacturing processes implementation into run-the-business operations.
• Coordinate of on-shore and off-shore support sub-contractors performing precision measurements, data analysis, and documentation creation and change order maintenance.

Confidential, Minneapolis, Minnesota

Principal Program Manager

Responsibilities:

• Lead/Manage/Coordinate product development core program teams for a variety of industrial, commercial, and medical products, working closely with customers and all engineering and interrelated functional work-streams, outside contractors, manufacturing operations, and suppliers to achieve customer expectations and program goals.
• Proactively engaged with leadership and franchise owners to ensure alignment with roadmap strategies, project milestones are met, customer requirements achieved, and risks/barriers are identified and mitigated throughout life cycle management.
• Primary communication interface to customer leaders to maintain operating and reporting mechanisms regarding: schedule, milestones, deliverables, budget, performance metrics, risks management, FDA strategy and launches.

Confidential, St. Paul, Minnesota

Senior Program Manager

Responsibilities:

• Manage/Coordinate R&D core program teams for design & development of infusion medication pump products, working with all engineering and interrelated cross-functional work-streams, outside contractors, and suppliers to achieve project goals.
• Serve as key communications conduit with senior leadership to maintain operating and reporting mechanisms regarding: schedule, milestones, deliverables, budgets, performance metrics, phase gates, risk mitigation, launch dates, FDA submission strategy, and life cycle management.
• Successfully launched three major hardware/software hospital and ambulatory infusion products to the market in 36 months.

Confidential, St. Paul, Minnesota

R&D Engineering Manager

Responsibilities:

• Led fast-paced scientific and engineering R&D team responsible for deaeration equipment design, development, manufacturing, and line extension projects for HPLC OEM customers, increasing YOY division sales by 40%.
• Project prioritization and coordinate all aspects of R&D projects and schedules, including; scientific experiments, engineering analysis, CAD design and drafting, BOMs, test specifications, technician tasks, prototype lab, procurement, pilot production, and metric reporting.
• Managed product life cycle through phase gate process to meet technical requirements, business objectives, intellectual property protection, manufacturability, and customers’ performance needs.
• Responsible for staffing and career development and performance appraisals.

Confidential, Arden Hills, Minnesota

Senior Technical Project Lead/Coordinator

Responsibilities:

• Led/coordinated dedicated R&D and operational core team activities for implantable heart failure lead projects, which included; design, develop, test, and evaluate to meet product requirements as well as FDA strategy.
• Managed, synchronized, and prioritized cross-functional support teams for lead projects, including; engineering, technicians, prototype lab, test lab, pilot line, procurement, suppliers, drafting and document control.
• Supervised day-to-day activities and priorities for procurement specialists, production control/build coordinators, and lab technicians. Responsible for staffing, career development and performance appraisals.
• Served as decision maker for ongoing lead project metric reporting, risk mitigation, design change implementation, inventory management, requisitioning/procurement, build workorders, and capital equipment (fixtures, molds, tooling) for pilot lines, clinical studies, and product launch.