Product Assurance Engineer∞

3M is seeking a Product Assurance Engineer for the Infection Prevention Division located in St. Paul, MN. At 3M, you can apply your talent in bold ways that matter. Here, you go.

Job Summary :

The person hired for the position of Product Assurance Engineer will focus on electronic hardware products in our device reprocessing business. This position will lead and support projects that positively impact product service, performance, and quality. This individual will work closely with plant and division Manufacturing Engineers, plant manufacturing personnel, division Product Assurance personnel, and component Suppliers, and will report directly to the Device Reprocessing Hardware Quality Manager.

This position provides an opportunity to transition from other private, public, government or military environments to a 3M career.

Primary Responsibilities include but are not limited to the following:

Drive existing product quality improvement through use of continuous improvement methods and tools, such as: Six Sigma, PPU (Product and Process Understanding), Design of Experiments, CQI (Customer Quality Index) and Quality at the Source
Support customers through complaint investigations and trending
Position entails interaction with other 3M US and OUS facilities
Position will involve working with 3M quality, product assurance, regulatory, manufacturing, laboratory, clinical, and tech service personnel and customers
Responsible, accountable and the primary spokesperson for product performance, product quality and be the customer representative for assigned products within the plant facility
Ensure the commercialized product design intent and product integrity as materials, processes, methods, and specifications change
Primary responsibility for leading the analysis, trouble shooting, verification testing, non-conforming product test and disposition
Responsible for change management as it relates to design changes driven by quality improvement, source of supply changes, or cost reduction efforts
Lead cross functional teams that include manufacturing, technical service and quality/regulatory engineers
Support and/or lead efforts on life cycle management, risk management, product and process improvements, and other product documentation efforts
Act as the primary product liaison between the plant and other divisional functions

Basic Qualifications:

Bachelor’s degree or higher in a science or engineering discipline from an accredited university
Electro-Mechanical experience in a private, public, government or military environment

Preferred Qualifications:

Bachelor’s degree or higher in Electrical, Biomedical Engineering, Mechanical or related discipline, from an accredited university
Electrical/mechanical aptitude
Experience in schematic and PCB design tools; Altium preferred
Electronic design experience
Firmware design experience
Experience working in manufacturing
Possess a sound quality and regulatory mindset
Project leadership experience
Minimum one (1) year of Lean manufacturing experience
Minimum one (1) year of combined experience in Quality, Technical, Manufacturing or Laboratory
Strong emphasis on applied statistical applications and continuous improvement methodologies
Working knowledge of product and process understanding (PPU) and Lean principles
Experience in product quality assurance for regulated products
Experience working with quality systems applied to the health care industry (Medical Device ISO 13485, FDA QSR and Drug GMP)
Demonstrated experience to analyze problems, diagnose root cause and apply corrective actions
Familiarity with FDA Quality Systems Requirements(QSR)
Strong analytical problem-solving skills
Strong collaboration skills
Excellent verbal and written communication skills
Self-driven with excellent organization and leadership skills
Experience with E-matrix and SAP