PROFESSIONAL PROFILE:

• 3+ years - Quality Engineer and Regulatory Compliance Specialist concentrating on Design Assurance activities for medical devices
• 5+ years - Project Engineer, Design Controls/ Project Coordinator for manufacturer of oxygen concentrators.
• 5+ years - Inside Sales, Applications Engineer for Engineered Systems, Industrial Equipment: gas separation, control valves, mixing equipment, filtration systems, piping

PROFESSIONAL EXPERIENCE:

Confidential, Rochester, NY

Quality Engineer

Responsibilities:

• Ensure compliance to quality system requirements for in vitro diagnostics equipment manufacturer.
• Provide oversight and approval of suppliers’ commissioning, qualification, verification and validation plans/protocols and reports including resolution of associated deviations/nonconformances.
• Review documentation for all design requirements and traceability.
• Provide input to quality processes for purchasing control, supplier change control and validation.
• Proactively identifies issues, troubleshoot and escalate concerns, as appropriate. Adhere to strict procedural and quality standards including thorough and accurate documentation and testing protocols.

Confidential, Amherst, NY

Regulatory Compliance Specialist

Responsibilities:

• Apply understanding of regulatory/standards and requirements to one or more areas of expertise ISO 9001, FDA (21CFR820), ISO 13485, 14971 and MDD (93/42/EEC).
• Facilitate design change controls for medical and industrial products. NPD implementation of design assurance, design control requirements and managing risk management files.
• Coordinate and oversee communications with outside testing facilities: provide technical files, risk files and support between test facility, regulatory and engineering.

Design Controls / Project Coordinator

Confidential

Responsibilities:

• Develop and maintain design control files for all research and development projects. Apply understanding of regulatory/standards and requirements to one or more areas of expertise: FDA (21CFR820), ISO 13485, 14971 and MDD 93/42/EEC.
• Assist Project Engineer to define design plan, technical files (including risk) and with design transfer proceedings.
• Schedule external lab reports for safety and EMC compliance. Perform tests with report follow-up in support of export requirements.
• Member of regulatory directed team to write multi-site procedures for ISO 9001, FDA and GMP.

Confidential, Amherst, NY

Project Engineer / R&D

Responsibilities:

• Conducted studies for process improvement, cost reduction and validation/verification for Class 2 medical device.
• Developed specifications,protocols/reports and coordinated test builds.
• Daily tasks included use of hand, electric tools: saws, drill presses, bench press and pneumatic drivers to repair/modify prototypes and improvise test apparatus.
• DAQ setup of operational parameters of prototype internals and components to measure temperature, pressure, flow, product and waste gas concentration, current, resistance, voltage, power.
• Performed sound measurements and storage/environmental tests.
• Supervised vendor requirements, drawing revisions and BOM entry.
• Completed design history files, risk review, technical files, test reports, technical files and other documentation required for engineering changes and design transfer proceedings.
• Wrote Assembly & Test procedures, Patient Manuals, Service Manuals and Quality inspection plans.
• Performed verifications for export standards and licensing.

Confidential, Amherst, NY

Service Technician

Responsibilities:

• Technical service and customer support for manufacturer of commercial oxygen generators.
• Responded to requests for troubleshooting assistance, parts quotes and field service.
• Repaired incoming commercial oxygen generators and rebuilt components: sieve beds, compressors, solenoid valves/ manifolds, filters/housings and regulators.
• Fabrication of high pressure gas hose assemblies and orifices.
• Prepared units and parts for domestic and export shipping.
• End users included veterinary hospitals, institutional aquariums and zoos, commercial fish farms, environmental remediation, wastewater and welding applications (muffler shops, commercial jewelers).

Confidential, Amherst, NY

Staff Engineer

Responsibilities:

• Primary client contact for domestic and international installations of power plant performance management software for consulting firm.
• Created and managed customer support database for tracking site details, software conflicts and service contract hours.
• Developed automated email reports using Crystal Reports, MS Excel and Outlook to send alarms, weekly or monthly markers to plant management.

Confidential, Angola, NY

Applications Engineer

Responsibilities:

• Provided equipment recommendations, proposals and end user support for manufacturer of liquid-solid filtration systems.
• Coordinated inquiry review, product selection, estimates and final draft of proposals with VP Sales.
• Proposals for filtration platforms included sizing of: pumps, hoppers and sludge dryers.
• Managed project milestones in accordance with contract schedule.
• Supported order entry and tracking. Post-sales support activity included writing Operations Manuals and arranging for equipment certification.

Confidential, Buffalo, NY

Inside Sales

Responsibilities:

• Responded to domestic and international RFQs and customer assistance for manufacturer of stainless seamless piping.
• Working knowledge of steam calculations and ASME, API, MIL standards as well as certifications required in regulated industries.
• Updated monthly division sales reports to international corporate management.
• Responsible for updating training SOP's in compliance with ISO 9001.

Confidential, Rochester, NY

Application Engineer

Responsibilities:

• Design recommendations, proposals and technical support for mixing equipment manufacturer.
• Equipment range from portable batch mixers to large scale continuous process equipment.
• Sized and quoted system components for performance improvements or repair.
• Recommended certifications for specific applications: wastewater, pharmaceutical and food.
• Coordinated project scheduling with in-house business units and vendors to meet customer deadlines.