Mark Erson Email & Phone Number

Saint Paul, Mn, Us

Minneapolis, Mn, Us

Oversee Engineering department which includes manufacturing engineering, project engineering, qualification and validation of processes, and release to production. Oversee our in-house tool shop for mold making and automation support. In charge of quality engineering and quality assurance personnel to ensure superior product quality. Head up the continuous improvement program and initiatives.

Minneapolis, Mn, Us

Oversee Equipment Maintenance Department, Tool Shop, Automation Engineering, LSR Development and Engineering, and Continuous Improvement Program. Support Medical Device component manufacturing in ISO Class 7 Cleanroom focused on liquid silicone rubber molding process development through manufacturing engineering oversight, equipment purchases, and developing relationships with material and equipment suppliers. Provide support for process validations and related data analysis. Support the manufacturing of all elastomeric sealing components and custom rubber parts across multiple industries and all of our manufacturing areas through management of my departments that impact all projects in significant ways.

Minneapolis, Mn, Us

Eden Prairie, Mn, Us

Quality System Alignment Project with ISO 13485:2016 Standard. This is a multi-site initiative to align all sites under one system.

Maple Grove, Minnesota, Us

As a Process Development Engineer, developed process maps and pFMEA's for the manufacturing processes. Implemented improvements to the balloon catheter line and continued to supervise the 10 operators in that value stream. Started the lean manufacturing journey with 5S activities throughout the facility. Problem solving in extrusion process, reflow and molding. Helped with facility layout and a new cleanroom build project. Conducted Right to Know Training for the facility.As a Quality System Manager, wrote new procedures for many of the main QMS sections per the requirements of ISO 13485 and FDA 21 CFR Part 820. Managed document control, calibration system, internal audits, preventive maintenance system, tool qualifications, customer complaints, CAPA's, NCMR's, cleanroom monitoring and certifications, biological testing, product testing, customer audits and ISO audits. Participated in supplier reviews. Management representative for the company.

As Director of Quality Assurance (5+ yrs) - Manage the 40-member Quality Assurance team for this privately-held contract manufacturer for the healthcare, aerospace, and defense industries. Areas managed include Quality Engineering and Validation, Supplier Quality, Inspection and Quality Systems.As Senior Engineer (9 yrs) - Managed a team of manufacturing engineers and automation engineers in developing manufacturing and inspection processes for products of our medical device customers. Participated in and owned development projects, equipment installations, clean room expansion projects, process validations and quality system improvements. Initiated Lean Six Sigma methodologies at the company.

Worked in the circuit board industry at several companies and throughout the evolution of one company that was melding and changing through mergers, acquisitions, and sell-offs. Industries served were Military, Aerospace, Automotive, Telecommunications, Server Board,Commercial Electronics.Grew to levels of middle management overseeing manufacturing floors, developing processes and procedures, establishing quality programs, and managing ever-changing populations of staff and department functions. Employed Lean principles and Six Sigma methodologies to solve problems and reduce the cost of manufacturing.