Shaun Lessik Email & Phone Number

Exton, Pennsylvania, United States

Lead international multi-disciplinary teams to develop wearable autoinjector proof-of-concepts incorporating mechanical and electronic elements. Design, fabricate, and test functional prototypes against device requirements and relevant standards. Regularly communicate with executive leadership to present progress and align on goals.

Telford, Pa

Developed and executed test method validations for customers' medical textile products and packaging utilizing techniques such as Gage R&R and Attribute Agreement Analysis. Led root cause investigations and implemented changes based on findings. Supported manufacturing quality inspections and testing as needed. Designed, tested, and reviewed customer product labels using Bartender.

Malvern, Pa

Led cross-functional teams to develop new electrophysiology and cardiac rhythm management access devices from design concept through regulatory clearance to full-scale production. Ensured focus was kept on patient safety and end-user satisfaction through testing, risk management, and user studies. Managed and authored design control documents and design history files. Used design expertise to support other departments as needed.

Malvern, Pennsylvania, United States

Malvern, Pennsylvania, United States

Supported new product development projects as the R&D representative on a cross-functional team. Authored design controls such as design verification protocols and reports and input-output matrices. Performed process development and validation activities such as writing protocols and reports, managing builds, and conducting tests. Worked with multidisciplinary teams to investigate and resolve issues related to field complaints and manufacturing processes. Contributed design expertise and manufacturing knowledge to support production and product launch.

Greater Philadelphia Area

• Built a motorized orthotic for patients with muscle extensor weakness in the hand• Analyzed hand mechanics to select appropriate device components• Designed custom finger splint and printed it via a rapid prototype machine• Developed design specifications and conducted verification/validation testing

Philadelphia, Pa

• Assisted in managing business development program for early-stage academic research in life sciences and healthcare IT• Assisted in preparing and submitting NIH and NSF research grant applications while maintaining up to five at a time• Contributed in initiating a business accelerator program for digital health start-ups

Exton, Pa

• Improved cutting machine to increase productivity and accuracy• Designed testing method to quantitatively analyze the wicking ability of a new product• Assisted with testing production methods to ensure updated specifications could be met• Conducted FMEAs on updated production processes• Collected data, analyzed results, and wrote reports for various product and packaging tests

Philadelphia, Pa

• Prepared multiple analytical, organic, and biochemistry labs on a weekly basis• Supervised three lab assistants and the lab in the absence of a lab director• Balanced managing and changing of multiple labs on a rigid schedule

Bachelor Of Science (Bs), Biomedical Engineering - Biomechanics & Human Performance

Certificate, Creative Writing And Publishing