Ling W. Email & Phone Number

Minneapolis, Mn, Us

• Created 2 new technologies and experimentally proved their technical feasibilities. Filed 8 provisional patent applications. Two patent pending are underway.• Introduced FDA waterfall design control for medical device manufactures into Integer. Created design input requirements, identified primary stakeholders and stakeholders needs, translated the stakeholder needs to system requirements, then flowed down system requirements to device-level performance requirements per FDA waterfall guideline. • Serve on the front end of nearly all design-type products development. And, provide training and consultation to the project teams with new product development, test method development, design verification and validation, clinical studies, and regulation alignment.

Minneapolis, Mn, Us

Worked on project management, new technology, product development, and implant surgical procedure; served as a product expert to cross-function departments; served as the subject matter expert to address legal and regulatory concerns; innovated numerous technologies for medical devices.• Managed a project with 12 cross-function team members and served as the technical leader to optimize a product design, which resulted in manufacturing cost reduction. The successful launch of the improved product led to savings of $1.5 million yearly for Medtronic.• Managed a project with 15 cross-function team members and served as the technical leader to standardize the design for Neuro Stim system connections, which impacted over 300 product models and had challenged Neuro for 7+ years. Exceptionally completed the product development and achieved FDA submission approval in less than 2 years. The standardization significantly saved Medtronic resources: customer phone calls were reduced from ~100 to 3 to 5 each month. • Led 10+ project teams and served as the lead engineer to thoroughly study the product performance issues. Strategically planned and executed the improvement, corrective, and preventive activities. Monitored product performance to ensure that improved system/product satisfy customer needs and business requirements.Created a surgical implant procedure to facilitate new product clinical studies. Traveled to the study sites to provide instruction to the surgeons about the implant procedure to ensure surgical success and good clinical outcomes. The successful clinical outcomes resulted in FDA approval.• Acted as an internal technical consultant and applied DRM skills to help a project team select product design concepts.• Provided technical direction as well as mentoring for junior engineers. Provided technical consultation, product life cycle management, and product failure analysis to multiple national and global function groups.

Worked on product development and project management, Urology.• Managed a team of six members to develop the 2nd generation Urolume stent delivery system. Successfully launched the new product to high volume manufacturing on schedule and within budget. Improved the performance of the second generation by 60% over the 1st generation.• Successfully completed market and technology assessment of kidney cancer treatments. The promising results from this pioneering investigation convinced the executives to enter the cancer market. Obtained 5-year funding for this cancer treatment project.

Marlborough, Ma, Us

Worked on new technology and product development, Cardiovascular. • Successfully developed and launched the 2nd generation diagnostic catheter. • Innovated ultra-thin wall guide catheter technology, which has been patented in the U.S. and internationally.

Master Of Science - Ms, Mechanical Engineering

Bachelor Of Science - Bs, Mechanical Engineering

Master Of Business Administration - Mba, Business Administration And Management, General