Michele Swaner Silver

About Michele Swaner Silver

R&D and Manufacturing Engineer: Concept-to-CommercializationBiomedical Engineer with extensive experience in the medical device industry: Research, Development & Manufacturing. Able to perform every step of the product development cycle, including identifying customer needs, idea conception, prototyping, preclinical & benchtop testing, analyzing data, supporting initial clinical use, transfer to production, and sustaining manufacturing. Unique skills to succinctly describe problem-solution correlations for reviewers and investigate failures. Diverse experience in Research & Development (R&D), Quality Engineering, and Manufacturing Engineering.Key skills & expertise: Early-Stage R&D- Identify User Needs, Voice-of-Customer, often via hands-on use of prototypes- Research disease states & anatomy- Generate specificationsPrototype & Test Medical Devices- Hands-on prototyping- Develop Test Methods, benchtop (in-vitro or ex-vivo) testing & analysis- Patents: Brainstorm concepts & support technical submission of applications- Pre-clinical (animal or cadaver) testing, often as hands-on, sterile support for physician / interventionalist in cath lab environment (i.e. stent implant procedure)- Device characterization testing to support formal Pre-Clinical Studies- Support clinical trialManufacturing- Scale up pilot manufacturing from prototyping to full-scale manufacturing- Design Verification / Process Validation- Sustaining manufacturing, continuous improvement, non-conformances (NCR) & Corrective and Preventive Action (CAPA).Quality- LIMS software configuration & customizationProducts - cardiovascular medical devices- Catheters / delivery systems (coronary, endovascular, peripheral, neuro, ablation)- Implants stent graft / PTFE; heart valve)- Combination devices (drug eluting stents)

Experience

1. Sr Industrial Engineer

   Medtronic

   Oct 2019 — Present · North Haven, CT, US

   Medtronic Covidien MITG (Minimally Invasive Therapies Group): Support commercial production and new capital equipment projects for large scale manufacturing site. Perform capacity analysis for current and proposed equipment / processes / products. Perform financial cost savings analysis for engineering improvement projects, including time studies and process routing modifications. Generate facilities layouts for new capital equipment and processes.

Education

• California Polytechnic State University-San Luis Obispo

  B.S., Industrial Engineering

  1990 — 1995

Skills

• Design of Experiments
• Iso 13485
• Minitab
• R&D
• U.s. Food and Drug Administration (Fda)
• Fda
• Quality Assurance
• Design for Manufacturing
• Dmaic
• Research and Development (R&D)
• Design Control
• Medical Devices
• Capa
• Quality System
• V&V
• Verification and Validation (V&V)
• Spc
• Biomedical Engineering