Steve P.
Author: A Hearty Price (working title) - shipping 2026 | Heart Disease Survivor | Cold-Brew Coffee Enthusiast | Design Quality Engineering Manager in Cardiac and Neurosurgical Medical Devices | Career planner
- Role
- Sr Manager, Design Assurance at AtriCure, Inc.
- Location
- Minneapolis, MN, US
- LinkedIn followers
- 500 followers
About Steve P.
Motivated Engineer/Change Agent with 16 years of experience in Medical Device, Aerospace, and Building Materials. Self-starter who thrives in a team environment. Performs duties ethically at all times. Experienced Auditor of Medical Device Quality Systems with working knowledge of IEC 60601, 21 CFR 820, ISO-14971 and ISO 13485, medical device design assurance (design V&V), process development (process V&V), manufacturing, installation, and service. I love a challenge and bringing a team together to meet a challenge.Specialties: Quality Management Systems (ISO 13485 and 21 CFR 820),Risk ManagementCapital EquipmentSterile DisposablesGeometric Dimensioning and TolerancingDesign ControlsSupplier DevelopmentCross-functional Team LeadershipStatistical Process Control
Experience
Sr Manager, Design Assurance
Mar 2023 — Present · Minnetonka, MN, US
Education
Minnesota State University, Mankato
BS, Manufacturing Engineering Technology major. Minor in Automotive Engineering Technology
1999 — 2001
University of St. Thomas
Master of Science, Systems Engineering and Regulatory Science
2011 — 2019
Hennepin Technical College
Certificate, Medical Device Manufacturing
2009 — 2009
University of St. Thomas
Medical Device Manufacturing Certificate
2011 — 2013
Skills
- Ppap
- Molding
- Continuous Improvement
- 21 Cfr
- Toastmasters
- Asq
- Process Validation
- Medical Devices
- Capa
- Iso 9000
- Quality System
- Quality Systems
- V&V
- Plastics
- Validation
- Dmaic
- Manufacturing Engineering
- Cqa
- Quality Management
- Iso 13485
- Solidworks
- Biomedical Engineering
- Quality Assurance
- Design for Manufacturing
- Process Capability
- Public Speaking
- Iso
- Fda
- Quality Control
- Injection Molding
- Design of Experiments
- Manufacturing
- Fmea
- Design Control
- Process Improvement
- Supplier Quality
- Machining
- Iso 14971
- Gd&T
- Fda Gmp
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