Shanna Helminen

Shanna Helminen

Senior Product Development Engineer @ RapidPulse, Inc.

About

Product Engineer with 20 years experience designing and developing catheters, guidewires, and other interventional and diagnostic devices. Experienced in all aspects of the medical device industry from concept development through product release in accordance with GMP/GDP standards as well as FDA regulations and ISO13485. Proven abilities to lead teams, solve complex problems and deliver high quality products. Experience in management of cross functional teams to complete projects on schedule and within budget

Country

United States

City

Fort Lauderdale

Industry

Medical Device

Skill

Medical Devices, ISO 13485, Validation, Minitab, Manufacturing, Product Development, Design of Experiments, Design Control, Manufacturing Engineering, SPC, FDA, Solidworks, Biomedical Engineering, FMEA, Design for Manufacturing, SolidWorks

Experience

RapidPulse, Inc.

Senior Product Development Engineer

RapidPulse, Inc.

LinkedIn
2023-2 - Present · 3 yrs 8 mos

Miami, Florida, United States

NAGL MedTech™

Principal Product Development Engineer

NAGL MedTech™

LinkedIn
2022-7 - 2023-2 · 8 mos
East End Medical

Senior Manufacturing Process Engineer

East End Medical

LinkedIn
2021-6 - 2022-7 · 1 yr 2 mos

Miramar, Florida, United States

Surmodics, Inc.

Senior Process Development Engineer

Surmodics, Inc.

LinkedIn
2018-3 - 2021-6 · 3 yrs 4 mos

Eden Prairie

Biomerics

Senior Manufacturing Engineer

Biomerics

LinkedIn
2015-7 - 2018-3 · 2 yrs 9 mos
Lake Region Medical

NPI Development Engineer II

Lake Region Medical

LinkedIn
2014-8 - 2015-7 · 1 yr

Chaska, MN

Develop new processes for new products

Lake Region Medical

Manfacturing Engineer II

Lake Region Medical

LinkedIn
2012-6 - 2014-8 · 2 yrs 3 mos

Manufacturing Projects: Develop new or improved processes on product lines.

Lake Region Medical

Manufacturing Packaging Engineer

Lake Region Medical

LinkedIn
2011-1 - 2012-6 · 1 yr 6 mos

Chaska, MN

Lake Region Medical

Associate R & D Engineer

Lake Region Medical

LinkedIn
2004-11 - 2011-3 · 6 yrs 5 mos

Chaska, MN

College Nannies, Sitters and Tutors

Tutor

College Nannies, Sitters and Tutors

LinkedIn
2009-3 - 2014-6 · 5 yrs 4 mos

Tutor students in Math, Science and ACT prep.

Education

Michigan Technological University

Michigan Technological University

LinkedIn

Engineering

Shanna Helminen's Contact Information

Email

******@***.com

Phone

(**) *** ****

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