ERIC MULDER
Minneapolis,MN
Summary
A senior/principal level Quality Engineer with a background in biotechnology and medical device industries whose responsibilities included product evaluations, quality assurance, corrective/preventative action plans, product investigations and validations and risk analysis and mitigation while working in a team environment and delivering results in a timely manner. Strong verbal and written communication skills. Proficient in Microsoft Office suite, Minitab, Windchill, qualification and validation protocols and reporting, product testing methods, test method validation and FMEA risk analysis. Knowledgeable in FDA Medical Device CFR, ISO 13485, 14971 and 90001.
Overview
24
24
years of professional experience
Work History
Process Quality Engineer
Davis Companies/Nyxoah
Brooklyn Park, MN
02.2025 - 12.2025
- Reviewed and dispositioned operation and performance qualification protocols and reports.
- Dispositioned contract manufacturer lot history records.
- Lead root cause investigation of product non-conformances.
- Conducted risk assessment using pFMEA.
- Process Quality Engineer. Product: Implantable Device.
Contract Process Development Engineer
ProKatchers/Abbott
Plymouth, MN
06.2024 - 12.2024
- 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 Process Development Engineer. Product: Catheter.
Contract Quality Engineer
Actalent (Aerotek) Staffing / Teleflex, Inc.
Maple Grove, MN
08.2021 - 08.2022
- 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 for EUMDR compliance.
- 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. Product: Catheter.
Contract Quality Engineer
Actalent (Aerotek) Staffing / Medtronic, Inc.
Plymouth, MN
06.2019 - 08.2021
- Standardize quality documentation review according to cGMP requirements through generation of standard templates and procedure alignment for EUMDR compliance.
- 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. Product: Interventional Lung System (Diagnostic).
Contract Quality Engineer
SSI Staffing / Philips Healthcare
Maple Grove, MN
12.2018 - 04.2019
- Perform DFMEA/UFMEA/PFMEA risk analysis remediation for product acquisition for EUMDR compliance.
- Spearhead deliverable completion by recruiting cross functional representatives providing leadership and guidance.
- Contract Quality Engineer. Product: Catheter.
Contract Quality Engineer
Real Lifesciences / Medtronic, Inc.
Brooklyn Park, MN
02.2018 - 12.2018
- 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. Product: Cardiac Intervention.
Contract Quality Engineer
Real Lifesciences / Phillips Medisize
Hudson, WI
09.2017 - 02.2018
- 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. Product: Ocular Implant.
Contract Quality Engineer
Aerotek Staffing / Smartrac - Linxens (RFID)
Chanhassen, MN
06.2017 - 09.2017
- 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. Product: RFID.
Contract Quality Engineer
TE Connectivity - Creganna Medical
Plymouth, MN
04.2016 - 04.2017
- 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.)
- Contract Quality Engineer. Product: Catheter.
Senior Quality Engineer
Greatbatch Medical
Plymouth, MN
02.2013 - 07.2015
- 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.
- Senior Quality Engineer. Product: Catheter.
Contract Quality Engineer
Wipro Technologies / Medtronic Inc.
Minneapolis, MN
03.2012 - 02.2013
- Conduct IQ, OQ, PQ activities for transfer efforts.
- Led cross functional team to generate equipment specification procedure and template.
- Contract Quality Engineer. Product: Neurological Leads.
Senior Quality Engineer
Medtronic, Inc.
Minneapolis, MN
04.2006 - 03.2012
- 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.
- Senior Quality Engineer. Product: Cardiac Leads.
Validation Engineer
Abbott Bioresearch Center
Worcester, MA
01.2002 - 01.2006
- 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.
- Validation Engineer. Product: Active Pharmaceutical Ingredient.
Education
Bachelor of Science - Chemical Engineering
Colorado School of Mines
Golden, CO12.1994
Skills
- Quality Management System documentation
- Process improvement
- Product quality
- Communication and leadership
- Measurement system analysis
- Statistical data analysis
- Gage R&R studies
- Design of experiments
- ISO 9001, 13485, 14971
- Problem solving techniques
- Process capability studies
- Statistical process control
- FMEA analysis
- Cross-functional teamwork
- Root-cause analysis
- IQ / OQ / PQ
- Quality risk assessment
- Quality documentation
- Quality management systems
- Preventive action planning
- Process validation
- Corrective action implementation
Timeline
Process Quality Engineer
Davis Companies/Nyxoah
02.2025 - 12.2025
Contract Process Development Engineer
ProKatchers/Abbott
06.2024 - 12.2024
Contract Quality Engineer
Actalent (Aerotek) Staffing / Teleflex, Inc.
08.2021 - 08.2022
Contract Quality Engineer
Actalent (Aerotek) Staffing / Medtronic, Inc.
06.2019 - 08.2021
Contract Quality Engineer
SSI Staffing / Philips Healthcare
12.2018 - 04.2019
Contract Quality Engineer
Real Lifesciences / Medtronic, Inc.
02.2018 - 12.2018
Contract Quality Engineer
Real Lifesciences / Phillips Medisize
09.2017 - 02.2018
Contract Quality Engineer
Aerotek Staffing / Smartrac - Linxens (RFID)
06.2017 - 09.2017
Contract Quality Engineer
TE Connectivity - Creganna Medical
04.2016 - 04.2017
Senior Quality Engineer
Greatbatch Medical
02.2013 - 07.2015
Contract Quality Engineer
Wipro Technologies / Medtronic Inc.
03.2012 - 02.2013
Senior Quality Engineer
Medtronic, Inc.
04.2006 - 03.2012
Validation Engineer
Abbott Bioresearch Center
01.2002 - 01.2006
Bachelor of Science - Chemical Engineering
Colorado School of Mines