Angela Salerno - Technical Program Manager Resume
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Resume:
Angela Salerno
nd Ave, Seattle, WA
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TECHNICAL PROGRAM MANAGEMENT PPROFESSIONAL
Bachelors of Engineering, Johns Hopkins University
A dynamic, motivated and results-oriented professional with over years of demonstrated career success in executing comprehensive hi-tech product development efforts. An organized leader who has worked with cross-functional teams located at multiple sites to launch products.
CAREER HIGHLIGHTS
- Project Management
- Software/Electrical engineering
- Strategy and Analysis
- Metrics and Reporting
- Technology Evaluations
- Team Building
- Regulated Systems
- Hardware Development
- Regulatory & Safety
- End User Qualification
- Yield improvement
- System Life Cycle
- Finance and Planning
- System Validation
- ITIL
- Change Management
PROFESSIONAL EXPERIENCE
Micron Technology, Seattle, WA. (High Performance Computing - yrs.)
- Design Engineering Manager– People Management -Bioinformatics ASIC development – -Present
- Product Core team Lead – Program management – Memory Cube product development— -
Retractable Technology, Dallas TX. (Medical Device Manufacturing - yrs.)
- Engineering Lead –Critical Care, Injection and Infusion Technology, Therapy engineering – -
Jain Foundation Inc, Bellevue, WA (Scientific Research - yrs.)
- Research Manager – Patient Diagnosis and Clinical Outcomes -- -
- Research and Grant Intern – Basic Muscular Dystrophy Research – -
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RESPONSIBILITIES AND ACCOMPLISHMENTS
Micron – Bioinformatics ASIC – Design Engineering Manager – Present
- Actively managed the core team technical leads thru multiple facets of the ASIC product development. Managed development activities to ensure product meets targeted content, cost and schedule objectives. Organized interdepartmental alignment discussions to develop new product development processes.
- Collaborated with customer teams on customer qualification plans and the PM team on business financials
- Managed build plans with outside manufacturer, coordinated and monitored program budget and spending. Collaborated with design, process, test and reliability engineering on product validation plans
- Collaborated with eng, ops, commodity & materials teams to establish cost tracking and reporting strategy.
- Interfaced regularly with PLM/PM/TCM to understand, manage and represent customer needs into product roll out.
- Executive management level communication of product development status cost and schedule.
Micron – Memory Cube Product Development - Product Core Team Lead -- –
- Successfully led cross-functional development activities-underpinning design specifications, product development, memory integration, and verification and launch activities.
- Orchestrated design/process modifications, configuration management and implemented technologies for robust manufacturability, good product reliability and improved product revenue and margins.
- Organized and led complex technical engineering-to-engineering (hardware and software) discussions, translating customer asks into specific tasks for implementation
- Interfaced with the product assurance, eng. and customer qual teams to drive root-cause FA closure activities. Coordinated qual. activities with several key OEMS and provided weekly updates to customers on product status. Worked closely with customer qual. management team and provided support on yield improvement actions. Working with overseas manufacturing organizations on technology implementation, product development and manufacturing issues resolution.
Retractable Technologies – Infusion Technology -- Engineering Lead -- –
- Led a team of ten engineers in the investigation and failure analysis of returned medical devices; including product evaluations, root cause determinations, and proposed corrective actions.
- Took over a team struggling with volume; provided organization and direction, rebalanced workloads, improved processes, and achieved measurable results.
- Monitored trending of product performance data, provided conclusions, and escalated emerging issues.
- Drove initiatives like Pre-Established investigations and the expedited distribution only process that reduced workload and increased efficiency while also maintaining compliance.
- Participated and led cross-functional teams; including members from user facilities, compliant centers, clinical, R&D, operations, quality assurance, safety, sustaining engineering and regulatory affairs.
- Safety Compliance Program: Configured reporting rules for automated submission of expedited safety reports to Health Authorities, Business Partners, Ethics Committees and Investigators. Ensure compliance with EMA, ICH, and FDA guidelines.
Jain Foundation – Limb Girdle Muscular Dystrophy Cure – Research Manager -- -
- Facilitated Pre-clinical Safety Pharmacology and Toxicology Studies so that Phase human clinical trials could safely be initiated.
- Supported Chemistry, Manufacturing and control (CMC) sections of an Investigational New Drug (IND) by generating data, writing sections, and editing the final dossier, so that a new drug application could be submitted.
- Prepared background packaged and participated in FDA meetings to review data with the FDA and so that Phase human clinical trials could begin.
- Coordinated activities that led to the optimization of testing output and employee productivity.
- Developed methodologies and directed studies in virology, microbiology, sterility, necropsy, analytical assays, and in vivo studies, resulting in an increased in methods to support internal customers.
Jain Foundation – Limb Girdle Muscular Dystrophy Cure – Grants Manager –-
- Fulfilled multiple roles; manager/leader of team(s) and a bench scientist functioning as team member.
- Directed & led technical service resources including R&D, providing technical project leadership & management for all requirements to support process/product development needs of operations, sales marketing & customers.
- Managed analytical support labs, led to new research services & products.
- Imitated and oversaw external corporation/collaboration with academic, government & industrial partners; also represented R&D function in high level business interactions and on scientific/technical conferences.
- Collaborated in + programs, projects, and contracts that were completed on time & budget providing, publications, presentations (supported +), and patents(+ assists)
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SKILLS
Proficient with PC and Microsoft Office: World, Excel, PowerPoint, and Visio
Skilled in regulatory software such as GCH, Trackwise, SAP, EasyTrack, Pilgrim & the FDA database MAUDE
Experienced in financial systems/software JDEdwards, project office, showcase, Essbase, & TOPS
Experienced in C++ and other scripting languages
