ERIC MULDER

Results-driven Quality Engineer with a knack for high productivity and efficient task completion. Specialize in statistical process control, root cause analysis, and continuous improvement methodologies. Excel in communication, problem-solving, and teamwork to enhance product quality and process efficiency.

• Medtronic Corporate Star of Excellence.
• ChemDesign Employee Recognition Award.
• Bayer Presidential Achievement Award.
• Runner-up Bayer Presidential Achievement Award.

• On the job training in medical device qualification and validation of product and manufacturing processes.
• On the job training in qualification and validation of Biomedical equipment and manufacturing processes.
• EMT Basic.
• OSHA Confined Space Rescue Training, 29 CFR 1910.146.
• Engineer Intern, State of Colorado.

• Process Quality Engineer, Davis Companies/Nyxoah, Brooklyn Park, MN, 02/01/25, Current, Reviewed for disposition operation and performance qualification protocols and reports., Reviewed for disposition contract manufacturer lot history records., Responsible for root cause investigations of product non-conformances., Perform risk assessment using pFMEA.
• Contract Process Development Engineer, ProKatchers/Abbott, Plymouth, MN, 06/01/24, 12/01/24, Generated and executed equipment installation qualification protocols., Reported findings of IQ protocols., Investigated and corrected issues with equipment operation., Worked with cross functional resources to route documents for DMR maintenance., Effectively communicated project status in extended team meetings maintaining accountability and transparency.
• Contract Quality Engineer, Actalent (Aerotek) Staffing / Teleflex, Inc., Maple Grove, MN, 08/01/21, 08/01/22, PFMEA risk analysis and remediation for product transfer of four product lines to Tecate Mexico., Spearhead implementation of new test method including authoring TMV’s, test procedures, training personnel, conducting gage R&R’s, analyzing data and reporting of results., Support OQ/PQ activities for receiving facility as an approver., Conduct IQ activities for implementation of test procedure and product transfer., Act as internal supplier quality rep for transfer supporting establishment of bill of material items and QMS documentation., Resolved investigations of non-conforming components and raw materials at receiving facility., Ensured compliance to company required training.
• Contract Quality Engineer, Actalent (Aerotek) Staffing / Medtronic, Inc., Plymouth, MN, 06/01/19, 08/01/21, Standardize quality documentation review according to cGMP requirements through generation of standard templates and procedure alignment., Root cause analysis and risk assessment resulting in effective and timely resolution of issue., Execution of design qualification protocols through QA lab analysis and data analysis using Minitab., PQ report generation and approval to support customer schedule requirements., First Article Inspection (FAI) of new process fixturing for implementation into manufacturing process.
• Contract Quality Engineer, SSI Staffing / Philips Healthcare, Maple Grove, MN, 12/01/18, 04/01/19, Perform DFMEA/UFMEA/PFMEA risk analysis remediation for product acquisition., Spearhead deliverable completion by recruiting cross functional representatives providing leadership and guidance.
• Contract Quality Engineer, Real Lifesciences / Medtronic, Inc., Brooklyn Park, MN, 02/01/18, 12/01/18, Perform DFMEA/PFMEA risk analysis for product transfer., Spearhead deliverable completion by leading cross functional representatives to achieve schedule milestones., Review and approve change orders., Conduct root cause and corrective action investigations addressing manufacturing non-conformances.
• Contract Quality Engineer, Real Lifesciences / Phillips Medisize, Hudson, WI, 09/01/17, 02/01/18, Standardize quality cGMP documentation through generation of standard templates and procedure alignment., Non-conformance root cause analysis and risk assessment resulting in effective and timely resolutions., Execution of PQ level design qualification protocols including data acquisition through QA lab analysis and data analysis using Minitab 18., PQ report generation and approval supporting customer schedule requirements., First Article Inspection (FAI) of new process fixturing to implement in manufacturing process.
• Contract Quality Engineer, Aerotek Staffing / Smartrac - Linxens (RFID), Chanhassen, MN, 06/01/17, 09/01/17, Coordinate final visual and quality inspections of final product., Reduced/eliminated product defects and improved process and product through root cause / corrective action activities., Reduced production down time by improving equipment PM., Reclaimed approximately 30% product on MRB into production., Perform test method validation of production instrumentation ensuring measurement and monitoring capabilities., Calibration coordinator for vendor onsite calibrations., Ensure ISO standards compliance of manufacturing process through gap analysis.
• Contract Quality Engineer, TE Connectivity - Creganna Medical, Plymouth, MN, 04/01/16, 04/01/17, Recovered $50,000+ of finances in returned supplier material., Facilitated supplier product optimization resulting in 10% process yield gains., Evaluate and disposition non-conforming product., Qualify new suppliers for cost saving initiatives., Cross functional team lead for risk analysis (PFMEA) and R&D process optimization., Develop and implement final QA inspection procedures., Statistical data analysis using Minitab and MS Excel (distribution analysis, descriptive statistics, ANOVA, capability analysis, etc.)
• Senior Quality Engineer, Greatbatch Medical, Plymouth, MN, 02/01/13, 07/01/15, Disposition non-conforming product., Improve product and process through root cause corrective action analysis., Reduce down-time through root cause and corrective actions that assured non-recurrence of cause., Performed test method validations for qualification of process monitoring., Participate in cross functional teams for risk analysis, process development and process monitoring implementation., Review and disposition IQ, OQ, PQ and PFMEA quality documentation.
• Contract Quality Engineer, Wipro Technologies / Medtronic Inc., Minneapolis, MN, 03/01/12, 02/01/13, Conduct IQ, OQ, PQ activities for transfer efforts., Led cross functional team to generate equipment specification procedure and template.
• Senior Quality Engineer, Medtronic, Inc., Minneapolis, MN, 04/01/06, 03/01/12, Led cross-functional teams to successfully complete PFMEA risk analysis, gage R&R and DOE for process optimization, and root cause investigations., Generate / execute protocols for existing and new manufacturing processes., Coordinate with test lab to initiate and prioritize test requests for analysis., Statistical data analysis and reporting of lab data protocol results., Provide 510 (k) and PMA regulatory submission guidance., Provide EUMDR regulatory submission guidance., Quality Core Team member for delivery systems and manufacturing transfer projects., Recover non-conforming released product for market use., Support transition of Manufacturing Execution System (MES) to FACTORYworks., Support sterilization qualifications / validations., Conduct root cause corrective action activities to support CAPA investigations.
• Validation Engineer, Abbott Bioresearch Center, Worcester, MA, 01/01/02, 01/01/06, Generate and execute IQ, OQ and PQ protocols for existing and new process equipment, cleaning and sterilization validations, and temperature-mapping studies on process equipment and environmental chambers., Coordinate and manage validation activities with production and plant support., Establish user requirements for Laboratory Information Management System (LIMS)., Review and report protocol results., Generate and update SOPs for equipment replacement and non-conformity investigations.