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.