Eric Lunde's Location
Greater Pittsburgh Region, United States, United States
Eric Lunde's Contact Details
Eric Lunde work email
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Eric Lunde personal email
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About Eric Lunde
- Twenty years combined Medical Devices & Semiconductor Capitol Equipment Experience as a Project / Program Manager, Systems Manufacturing Engineer, Quality Engineer, & Quality Assurance Manager- Project Managed multiple New Product Introductions- Lean Six Sigma Green Belt Certified- ISO 13485, ISO 9001, FDA regulatory experience- Experienced Process and Test Designer- Experience in working with mechanical, electrical, electronic, and optical equipment- Experience working with sterile, implantable, and reusable medical devices- Experienced in the creation of Manufacturing and Quality process and procedures- Worked as a Group Supervisor with 10 reporting personnel in the US NavySpecialties: Project Management, Process Engineering, NPI Development, Sustaining Engineering, Quality Acceptance, Design Verification, Process Validation, Process Documentation, Data Analysis, Problem Solving
Eric Lunde Work Experience Details
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Sr. Qa ManagerHaemonetics May 2018 - PresentBoston, Ma, Us -
Sr. Qa Manager, Finished DeviceCadence Inc. Dec 2016 - May 2018Staunton, Va, Us -
Quality ManagerCadence Inc. Aug 2014 - Dec 2016Staunton, Va, Us- As the sole Quality person on-site for first 9 months of employment, I performed all Incoming, in-process, and Final inspections as well as final lot release activities on top of all other Quality activities- In one year, transferred 13 Finished Devices from the OEM to Cadence Device while acting as the Quality representative/Project Lead.- Devised and executed a core plan for re-architecting the Quality Management System due to systemic issues discovered during initial reviews. - Reduced the number of QMS documents from 157 to 112 documents while better aligning them to business needs and adding needed processes.- Audited by multiple OEM's with no findings.- Have written multiple Master Validations, IQ/OQ/PQ's, Label Validations, Process Validations, etc...- At the request of the customer, flew to their facility to assist with the transfer of product and final customer qualification of Cadence Device as the Finished Device provider.- To assist Operations, wrote the Travelers and MI’s for the TransPort Family for onboarding- Covered Operations Manager on the 1st day of Samurai build for the 1st production build- Actively enables other department leaders to modify Quality System procedures that affect their groups, as subject matter experts, with only guidance on Quality System requirements.- Easily shift between quality functions, multiple product family onboarding’s, and Operation functions.- Made the decision to actively move from intermittent cleanroom testing based on cleanroom activity to regular testing and monitoring to establish a baseline that can easily be shown to customers with little/no explanation.- Provided 1-on-1 training regarding document control on training quality system operation to an individual with minimal experience regarding implementation of these types of systems.- Regularly give 1-on-1 and small group training as to why activities are important and how individual’s actions/inactions affect Cadence Device and customers.
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Quality Assurance ManagerPivot Medical Nov 2012 - Aug 2014- Responsible for the strategy, administration, and direction of the Quality Assurance organization. - Has overall responsibility for the Quality Assurance Department, including Receiving Inspection, Supplier Quality Assurance, In-Process Quality Assurance, Sustaining and New Product Development Quality Engineering, Sterility Assurance and Microbiology activities. - Assigned as the Alternate Management Representative for the company.- Leading all quality activites for product moves to contract manufacturing.- Leads quality planning activities for new product development resulting in 22 new devices launched in 1 year. - Works with R&D and Manufacturing Engineering to assure the effective development and qualification of inspection and test methods and equipment. - Responsible for input to and the running of the Management Review process for systems assigned to Quality Assurance.- Lead a cost reduction effort resulting in $162k/yr savings.- Working knowledge of sterilisation process requirements (Gamma, EtO, & Steam) and basic microbiology.- Currently have six direct reports (3 engineers and 3 technicians).- Performed and directed product/process analysis for launch, cost reduction, quality, and efficiency improvement.- Performed multiple site audits/reviews for critical suppliers & contract manufacturers with the goal of business realignment.
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Principle Quality EngineerPivot Medical Dec 2011 - Nov 2012- Lead a major reduction of Incoming Inspection based on Risk and Statistical Analysis resulting in a savings of 3800 man-hours/yr.- Lead the selection and purchase of capitol inspection equipment to improve accuracy and throughput for incoming inspection.- Wrote, reviewed, and approved multiple protocols for Design Ver/Val, Process Validation, Biocompatability, and sterilization- Acted as the responsible QE for multiple Design Programs- Re-wrote the Pivot Supplier program to increase efficiency and accountability
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Quality ConsultantBe Technology Mar 2012 - Nov 2012Designed and instituted the initial Quality System components of:- Design Control- Risk Management- Software Management- Training- Supplier Management- Statistical Analysis- Equipment Calibration- Document Control
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Sr. Technical Quality EngineerCutera, Inc Oct 2007 - Dec 2011Brisbane, Ca, Us- First QA Engineer for the company currently directing two personnel- Represented Quality / Reliability group in all New Product Introduction- Oversaw the reduction of non-conforming material resulting in a 50+% reduction.- Rewrote NCR & Incoming Inspection policies for per FDA 21 CFR Part 820 and ISO 13485 regulations- Responsible for developing, executing, and documenting protocols to verify and validate device designs and manufacturing process - Responsible for writing and approving Engineering Change Orders (ECO’s) and Verification and Validation (V&V) protocols for the Quality Department- Investigates and resolving all Safety Complaint issues for all company products - Technical representative for the Titan XL recall which stemmed from Safety Complaint findings- Perform multiple DOA / Early Failure investigations leading to process & design changes- Represents Cutera in all Supplier related technical issues- Created a completely new Supplier Selection procedure and quantitative scoring matrix.- Created the corporate scorecard for vender performance based on impact factors from various departments.- Directs the Supplier Audit Program for validating current and new suppliers- Performs supplier audits and devises / advises suppliers on corrective & preventative actions- Writes and institutes Quality Agreements for key suppliers per FDA guidance documentation- Responsible for control, disposition, & root cause/corrective action analysis of CAPA’s, SCAR’s, & NCR’s - Managed multiple Six Sigma Projects resulting in $380,000/yr in savings- Rewrote the re-manufacture process for YAG lasers that resulted in a $120,000 savings per year.- Lead the redesign of the treatment flash lamps to extend field life resulting in an average 33% longer life and lower material costs.- Managed the redesign of all systems packaging per ASTM standards resulting in a reduction from 5% to < 1% damage rate and a 31% cost reduction. -
Npi Project ManagerKla-Tencor Oct 2004 - Oct 2007Milpitas, California, Us- Manage projects from detailed definition through post-release analysis with a multi-disciplines, global team. - Developed the product strategy to take a new product directly from NPI to offshore facilities production; a first for KLA-Tencor.- Responsible for verifying that all products comply with DFX, OSHA, ISO, CE, and other required standards- Address all project dependencies, including internal training, development, design stability, and material / facility readiness. - Manage and communicate project status at all levels, including milestone performance against plan, resource utilization, risk factors, and possible implementation.- Develop, monitor, track, and report detailed project strategies, plans, and schedules in line with corporate management goals.- Proactively identify, mitigate, and resolve issues impacting project implementation at the project and task levels- Responsible for the successful Intel Copy Exact Program for NPI on the Crossfire Program -
Lead Mfg. EngineerKla-Tencor Feb 2005 - Oct 2006Milpitas, California, Us- Responsible for all technical escalations; product software assessment for NPI manufacturing; Process creation, Design and Spec validation, and acceptance- NPI Overall technical expert for manufacturing, install, and field upgrade teams- Developed guidance on cost effective volume system and assembly manufacturing for NPI projects.- Responsible for the training of Manufacturing, Install, Upgrade technicians and engineering team.- Investigated and analyzed quality problems of first article parts to determine cause and corrective actions.- Responsible for Specification and Design for requiredManufacturing and Quality assurance tools needed to support the Manufacturing Operations.
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Manufacturing EngineerKla-Tencor Jan 2004 - Feb 2005Milpitas, California, Us- Responsible for all process and technical escalations for Manufacturing, Field Install, and Field Upgrade Groups for 23XX product lines.- Scope of work included process, testing, design improvement/development of system parts.- Developed new Install process saving 5 days at customer site and resulting in $7,500 savings per install- Rewrote Manufacturing Process to remove 14 days of cycle time resulting in ~ $140,000 savings per tool.
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Test EngineerKla-Tencor Jul 1999 - Dec 2003Milpitas, California, Us- Made Lead Technician over more experience technicians.- Assigned to act as an Engineering Technician in New Product Introduction (NPI) for manufacturing.- Efficiently managed the assembly, calibration, and troubleshooting of multiple Wafer Inspection tools for several product lines.- Cross-trained in optical assembly and alignment.
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Fire Controlman Electronics TechnicianUss John Paul Jones (Ddg53) Oct 1993 - Jul 1999- Managed 10 technicians in two separate work groups as a Group Supervisor.- Effectively planned (weekly, quarterly, and five year plans) budgeting and maintenance for 2 work groups.- Assisted in the planning of the five-year overhaul of the FCS and Display work centers.- Responsible for writing the evaluations of personnel- Lead Technician responsible for Fire Control Systems (FCS), Operational Readiness Testing Systems (ORTS), and 400Hz Power conversion Systems- Earned Enlisted Surface Warfare Specialist (ESWS) pin
Eric Lunde Skills
Iso 13485
Quality Assurance
Quality System
Medical Devices
Manufacturing
Six Sigma
Product Development
Fda
Capa
Design Control
Design Of Experiments
Testing
Validation
V&v
Quality Management
Cross Functional Team Leadership
Iso 14971
R&d
Engineering Management
Jmp
Iso
Quality Control
Manufacturing Engineering
Engineering
Failure Analysis
Iso Standards
Troubleshooting
Software Documentation
Quality Auditing
Process Engineering
Verification And Validation
Fda Gmp
Microsoft Office
Risk Management Plans
Quality Systems Design
Spc
Lean Manufacturing
Supplier Quality
Process Improvement
Eric Lunde Education Details
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East Carolina UniversityBs Industrial Technology -
Mission CollegeAs Computers / Electronics Technology
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Fire Controlman 'A' And 'C' Schools
Frequently Asked Questions about Eric Lunde
What company does Eric Lunde work for?
Eric Lunde works for Haemonetics
What is Eric Lunde's role at the current company?
Eric Lunde's current role is Sr. QA Manager at Haemonetics.
What is Eric Lunde's email address?
Eric Lunde's email address is er****@****ast.net
What schools did Eric Lunde attend?
Eric Lunde attended East Carolina University, Mission College, Fire Controlman 'a' And 'c' Schools.
What skills is Eric Lunde known for?
Eric Lunde has skills like Iso 13485, Quality Assurance, Quality System, Medical Devices, Manufacturing, Six Sigma, Product Development, Fda, Capa, Design Control, Design Of Experiments, Testing.
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