James LaValle
Mahtomedi,USA
Summary
Engineering professional with proven ability to innovate and solve complex technical challenges. Known for delivering high-quality solutions and driving team success through effective collaboration and adaptability. Skills include systems analysis, project management, and technical troubleshooting.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Product Quality Specialist
3M
01.2019 - Current
- Developed and validated test equipment to assess material compatibility, verify design features, and mitigate risks during product qualification and release testing which led to a 50% increase in failure mode identification rate.
- Assessed varying materials to improve structural reliability and reduce customer complaints by 20%.
- Led 150+ change management projects (CMPs) across equipment, process, and product design to reduce financial risk and support ~$120M in annual sales.
- Negotiated with vendors to define testing parameters to improve consistency of raw materials by 60% leading to improved compliance with 3rd party certifications.
- Managed global customer feedback across 7 sites, reducing average complaint response time from 70 days to 5 days.
- Developed and managed 33+ CAPAs to resolve and prevent product and process failures, ensuring regulatory and quality compliance.
Senior Quality Engineer
Steris/ Johnson & Johnson
01.2018 - 01.2019
- Developed and executed innovative solutions to prove product compliance, salvaging over $10M worth of product.
- Analyzed production loss and cost of quality to provide actionable recommendations resulting in a 20% yield improvement and $5M in cost reductions.
- Resolved 32 CAPAs, driving timely and effective closure and ensuring sustainable corrective actions.
- Conducted root cause analysis and implemented corrective actions on over 200 nonconformances to enhance product quality and compliance.
Process Improvement Engineer
Steinwall Scientific
01.2016 - 01.2017
- Acted as liaison between customers, vendors, and product engineers to gather requirements and resolve complaints, correcting over $1.5M in losses.
- Analyzed production loss and cost of quality to recommend process improvements and quantify revenue impact – improving scrap rates from 50% to under 5%.
- Authored 10 peer-reviewed technical articles on injection molding process improvement strategies and outcomes.
Product Engineer (contract)
3M
01.2014 - 01.2016
- Provided technical support to sales teams, enabling them to better communicate product benefits and features to customers.
- Published reports, testing protocols, and procedures for product suitability and stability to align with ISO 9001 and ISO 11133:2014.
Pharmaceutical Scientist
Perrigo Company
01.2013 - 01.2014
- Performed chemical and microbial testing in accordance with USP regulations.
Product Quality Engineer, contract
Boston Scientific
01.2012 - 01.2013
- Performed medical device testing to verify compliance with FDA regulations.
Clinical Biochemist
University of Minnesota, Cancer Research Center
01.2009 - 01.2012
- Analyzed biological samples and conducted animal handling procedures.
Education
B.S. - Biochemistry
University of Minnesota – Twin Cities
01.2009
Skills
- Engineering change management
- Risk management
- Root-cause analysis
- Corrective and preventive actions
- Process modeling & optimization
- Process verification & validation
- Statistical data analysis
- Design of experiments
- Process & Product Qualification
Accomplishments
- Recouped $1.5M in losses through effectively helping with statistical reviews of processing parameters.
- Documented and resolved 60+ CAPAs and 300 NCs which led to $20M in losses.
- Collaborated with change management teams for150+ projects to reduce financial risk and expand market reach by ~$120M.
- Achieved a 20% increase in yield & a $5M in cost reductions by optimizing process oversight.
- Supervised team of 3 staff members for the design and development and validation of test fixtures.
- Directed risk management for 3,200+ SKUs to enhance customer safety, manufacturing efficiency, and liability mitigation.
Certification
- Certified Quality Engineer (CQE), American Society of Quality (ASQ), 2017 - Present
- Combat Health Specialist, Army National Guard, 2003 - 2007
Applicable Standards
ISO 9001, ISO 13485, ISO 14971, ISO 11607, ISO 11135, ISO 14644, ISO 14698, USP, CFR 21, NSF 42, NSF 58, NSF 61, NSF 401
Publications
- Residual Stress, Molding Views, 2016
- Injection Molding with an Additive Manufacturing Tool, SPE ANTEC, 2017
Timeline
Product Quality Specialist
3M
01.2019 - Current
Senior Quality Engineer
Steris/ Johnson & Johnson
01.2018 - 01.2019
Process Improvement Engineer
Steinwall Scientific
01.2016 - 01.2017
Product Engineer (contract)
3M
01.2014 - 01.2016
Pharmaceutical Scientist
Perrigo Company
01.2013 - 01.2014
Product Quality Engineer, contract
Boston Scientific
01.2012 - 01.2013
Clinical Biochemist
University of Minnesota, Cancer Research Center
01.2009 - 01.2012
B.S. - Biochemistry
University of Minnesota – Twin Cities
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