Eric Lunde Email & Phone Number

Boston, Ma, Us

Staunton, Va, Us

Staunton, 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.

- 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.

- 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

Designed and instituted the initial Quality System components of:- Design Control- Risk Management- Software Management- Training- Supplier Management- Statistical Analysis- Equipment Calibration- Document Control

Brisbane, 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.

Milpitas, 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

Milpitas, 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.

Milpitas, 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.

Milpitas, 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.

- 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

Bs Industrial Technology

As Computers / Electronics Technology

Education record