Greater Boston
Product development and business professional with a proven track record in Fortune 300 companies. Over fifteen years of leading diverse and global cross functional teams to infuse strategic products into business portfolios. Driven to achieve customer satisfaction and launch success. Hands-on approach throughout the NPI process. Hands-on manufacturing engineering skills to deliver products using lean and six sigma manufacturing principles. Seeking career opportunities that can benefit from either my project management or manufacturing engineering skills. Specialties: Project management using MS Project Microsoft office proficiency Strong communication skills Traditional and Virtual team leadership Able to lead multiple projects simultaneously Lean process development through Six Sigma implementation Sustaining engineering supporter Intellectual property development with patents and trademarks 3D CADD system design and layout- Autodesk & Solidworks Electro-Mechanical designer Cast polymer processing expertise Automated Test equipment development Pneumatic and electronic system integration Linear and non-linear FEA Micro-fluidic and Lab on a chip design and fabrication experience Fluent in German
Sr. Design and Process Engineer who translates and maintains the voice of the customer design inputs into custom fabricated plastic fluidic systems. - Manages new design application integration into manufacturing on a daily basis using Solidworks. - Manages legacy applications to adopt design and process improvements. - Coordinates and trains resources to achieve production goals. - Conduct activities in accordance with ISO 9000 procedures. Creates QC inspection plans and procedures. - Developer of custom fabrication processes to produce microfluidic assemblies. - Bonding of difficult materials such as COC and COP thermoplastics. - Produce detailed work instructions and reports based on validated processes using Microsoft Office. - Conduct and document FAI and AQL inspections using CMM equipment to customer specifications. - Collaborates directly with customer design engineers,quality, and procurement representatives. - Designer, fabricator, and validation of manufacturing fixturing and assembly aides. - Coordinates personnel in conducting fabrication operations for specialty assemblies.
Process and product development engineer to insure that micro-fluidic lab on a chip bonding met weekly demand and development requirements. • Developed R&D assembly and test procedures. Coordinated R&D production staff activities utilizing procedures. • Researched and qualified laser machining vendors of scored lidding foils for liquid reagent containment. Conducted vendor reviews and documented action items against project plans. • Hands-on developer and troubleshooter of hydraulic press processes for micro-fluidic chips. Monitored production SPC process metrics for weekly tracking reports. Developed process work instructions for operator use. • Designed foil scoring dies, test equipment, and reagent assay reservoirs using Solidworks 2013. Hands-on user of equipment to conduct performance validation tests. Prepared validation reports and presentations. • Process and tooling developer for integrated DNA and Particulate filters within bio-chip sets. Qualified materials for integration. Established SPC tracking metrics. •Served as the Divisional Safety and Chemical Health Officer. Interfaced with local and state agencies to maintain site compliance with regulations. Conducted weekly safety audits and prepared finding reports. Mass. DEP wastewater grade 2-I license #17351 exp. 4/2017. Certified Mass. RCRA 2015.
Project leader of a complex $80 million project for the Depuy Spine franchise. The project focus was to release sterile Titanium and Peek spinal reconstructive implants into the U.K. EMEA, and Asia-Pacific markets. • Developed project timelines using to coordinate the launch for sterile packaging for the release of twenty product brands. Successfully launched the first group of implants to support the sterile implant switch in the U.K.. • Translate voice of customer input into product requirements documents for product development purposes. • Utilized MS Project to coordinate all project deliverables. Collaborated with key sponsors to apply resources to bring the projects to completion. • Conducted monthly project review updates to upper management detailing timeline, cost and launch objective adherences. • Leading a cross functional team of thirty core people of various disciplines. The team was dispersed in three different countries based on the established JnJ business structure. Insured that design, QA engineering, microbiology, planning, manufacturing, distribution, marketing, v&v, and RA communicated to achieve goals. • Developer of the project DHF using Agile to support organizational and FDA regulatory requirements. • Leader of DFMEA, and PFMEA reviews in support of internal and regulatory requirements. • Conducted lessons learned activities as a part of continuous improvement. Interfaced with regulatory team members related to FDA and international MD approval agencies.
Leader of virtual and direct product development teams per NPI processes for analytical and medical instruments. • Developed Custom and Market driven products - Integrated fluidics and electronic systems within medical device systems for Haemonetics, GE medical, Baxter Healthcare, Agilent, and JnJ. • Translate voice of customer input into product requirements documents for product development purposes. • Prepared financial proposals with sales for internal management and customer presentations. • Utilized Microsoft project to track project milestones and action items associated with cross functional teams. Communicated weekly review results with team members via meeting minutes. Updated sponsors via monthly project updates. • Extensive knowledge of plastic injection molding of thermoplastics, and elastomers. Equally knowledgeable using metals, and composites. Conducted FAI activities. Managed vendor reviews and quality issues. • Leader of DFMEA, and PFMEA reviews in support of internal and RA requirements. Reconciled internal and customer CAPA activities. • Hands-on approach towards sourcing materials for and building and testing R&D prototypes. • Lead manufacturing engineering activities. Engineering liaison for medical device ISO-9001 audits.
Responsible for leading virtual and direct product and technology development teams per NPI processes. Introduced and developed the innovative X-valve. • Coordinated multiple direct and indirect product development engineering teams. Lead multiple simultaneous NPI efforts for new fluidic system product releases. Developed custom and market driven products • Translate voice of customer input into product requirements documents for product development purposes. • Collaborated with project sponsors at the divisional and corporate level to secure R&D funding. • Individual contributor towards the development of electro-mechanical engineering drawings, and hardware specifications. Hands-on approach in developing prototypes. • Developer of new processes and work instructions in prototype and production phases. Generated bills of material for production and costing purposes. Responsible for margin analysis and incremental cost reductions. • Coordinated and participated in product sustaining engineering functions. Conducted Kaizen events. • Lead and participated in Lean manufacturing activities to increase throughput and reduce ergonomic issues.
Coordinated the department resources to deliver engineering designs for product and tooling development. • Coordinated multiple CADD resources to insure that simultaneous projects were completed against timeline objective. Developed the fixture development and preventative maintenance processes in the division to improve tooling quality and production uptime. Collaborated with engineering to develop detailed schedules. • Co-Inventor of the Solenoid actuated X-valve and X-system products; patents 6,684,896 B2 / 6,523,570 B2 • Hands on user of multiple CAE, 3D-CADD, Electro-magnetic, Linear and Non-linear FEA software packages to facilitate product development. Conducted tolerance studies. Checked drawings per ANSI-Y14.5 standard.