Abby Wilms Email & Phone Number

• Responsible for leading the project management team, including hiring, managing team, and setting expectations.
• Establish, maintain, and improve effective culture, processes, training for project management team.
• Project manager responsible for orchestrating cross-functional technical teams.

• Responsible for leading the project management team, including hiring, managing team, and setting expectations.
• Employed project management knowledge to set a culture of excellence, establish best practices, and leading by example.

Kansas City Metropolitan Area

• Orchestrated cross-functional team activities to achieve established goals and meet project milestones for electromechanical medical device product development.
• Managed client relationships to understand client's objectives and achieve project goals.
• Established and maintained project plans, including project scope, schedule, and budget.

Covington, GA

• Directed cross functional team in design and development of electromechanical medical device products.
• Managed project timelines, budgets, risks, resources, and communications to management.
• Coordinated internal procurement and operations team, to identify, evaluate, and select new product manufacturing site among internal facilities and contract manufacturers.
• Managed external engineering firms for contract development services to meet budget and timeline constraints.
• Directed contract manufacturer throughout product design transfer to production and scalability for product launch.
• Established product requirements to IEC 60601-1 and oversees compliance testing conducted by external test lab.

Covington, GA

• Generated criteria for new product formative study and directed third party vendor in study implementation.
• Directed relationship with external contract engineering firm to meet contract budget and timeline constraints.
• Interviewed clinical personnel to develop design requirements for new urological drainage products.

Covington, GA

• Collected and analyzed consumer feedback during in-home interviews with users and caregivers to drive future product requirements.
• Identified and developed content for help function in online portal utilized by clinicians.
• Evaluated marketing product claims to facilitate internal compliance review and approval.

Nogales, Mexico

• Organized cross functional team to support new production introduction into manufacturing plant.Managed IQ, OQ, PQ process qualification for product subassemblies.
• Oversaw product component qualifications including first articles and tool validations.
• Worked with suppliers to create new design specifications to support product design change.

Mason, OH

• Engaged with domestic and international clinicians to establish procedural understanding, product user needs, and discuss potential product opportunities.
• Managed design verification testing including development of test methods, associated validations, protocol development, protocol execution, and final reports.
• Coordinated with regulatory department to outline test requirements in support of substantial equivalency testing for 510(k) premarket notifications.
• Managed testing conducted in animal labs to verify and validate medical device design and product intended use.
• Created design and material specifications, inspection documents, and drawings for components, subassemblies, and finished products.
• Coordinated with manufacturing facilities to develop manufacturing instructions, inspection documents, tooling drawings, process setup forms, and process FMEAs.

Vernon Hills, IL

• Project leader for class II medical device product within the soft tissue biopsy market.
• Oversees team of quality, regulatory, manufacturing, and packaging engineers on new product development.
• Coordinates with marketing team members to identify customer needs and translate them into product specifications.
• Executes performance testing on device components following manufacturing process changes.

Cincinnati, OH

• Designed medical device utilizing ultrasound technology to aid users in identifying the location and depth of the spinous processes of an obese patient during a lumbar puncture procedure.
• Observed clinical procedures and worked with clinicians to identify procedural issues and to outline solution requirements.
• Researched and constructed an ultrasound phantom to mimic the acoustic properties of adipose tissue for prototype testing.
• Completed signal processing and analysis to successfully correlate ultrasound transducer signal to depth of vertebral bone.
• Tied for first place in the program’s annual competition, as judged by industry leaders, clinicians, and engineering professors.

Centerville, OH

• Established manufacturing process instructions and quality inspections for plastic injection molded medical components.
• Led manufacturing equipment qualifications, process verification activities, and completed all associated documentation.
• Developed 3D models and utilized 3D printing technologies to create prototypes and determine manufacturability based on customer design requirements.
• Assisted in the expansion of a quality system to comply with FDA 21 CFR 820, ISO 9001, and ISO 13485.
• Coordinated with suppliers to create custom equipment and develop manufacturing techniques for production use.

West Chester, OH

• Represented product development team during surgical procedures following market release and FDA approval of cardiac cryo-ablation capital equipment.
• Trained company sales representatives, cardiothoracic surgeons, and operating room staff on new product use.
• Reviewed engineering component and assembly drawings in preparation for engineering and manufacturing pilot builds.
• Consulted with suppliers on custom component design and purchasing.
• Initiated testing of prototypes and new product materials for second generation cryo-ablation single use device.

West Chester, OH

• Performed preliminary testing on new product development devices and wrote corresponding protocols and final reports.
• Validated engineering design of new products based on product specifications.
• Created operations process instructions and led engineering pilot build activities.
• Collected and analyzed data to make design recommendations to product development team.