Derek Speer Email & Phone Number

California, United States

Irvine, California, United States

•Founding member of the Advanced Development team, helping to build the team of 15 engineers while cultivating an inclusive, energized, cohesive, and thriving work culture.•Worked closely with project sponsor and cross-functional team members to plan and develop scope, deliverables, required resources, work plan, budget, and timing for a new electrotechnical imaging system.•Managed new competency for the business, essentially building a start-up within a start-up from scratch. First time for the business in complex programs that involve software, capital hardware, and electomechanical component development(IVUS). •Identified, built and managed relationships with external design partners and manufacturing suppliers, as well as led internal cross-functional teams towards programmatic milestones and integration goals. •Analyzed, evaluated, and overcame program risks, by utilizing traditional project management and agile methodologies to direct the team. •Drove the team to an optimized critical path, while ensuring program compliance with all quality and regulatory guidelines and requirements.•Navigated the team through programmatic key decision points by leveraging change management principles that united the team through encouraging team engagement and empowering critical thinking.•Developed and managed budget for projects while delivering against established business goals/objectives.

Irvine, California

•Lead intra-company product transfer projects within different geographies•Interface with senior management to communicate / report progress and receive strategic updates impacting the projects•Develop holistic and detailed plans and roadmaps for project execution•Develop strategies to ensure successful execution of projects•Organize and lead multifunctional project teams to ensure timely implementation of the sub-tasks and ultimately the project•Closely monitor progress vs. plan and take action as required to keep project on track•Provide direction to the cross-functional team members as required•Provide input to solve complex problems including, but not limited to, those related to process, equipment, material, supply chain, documentation, equipment validation, IQ/OQ/PQ, ERP, PLM, and other applicable QMS / business processes•Provide technical leadership for the projects. Lead and coordinate activities of engineers and technicians in support of process and equipment development, process trouble shooting, and custom equipment procurement•Prepare, review, and approve manufacturing instruction, protocols, reports, and other controlled documentation•Lead and participate in documented vs. actual gap analysis activities•Participate in resolution of Non-Conformances and Corrective and Preventive Actions •Perform and present capacity analysis for existing and projected scenarios•Conceive and propose creative solutions to solve difficult capacity constraints•Provide supervision and mentorship to engineers, technicians, and other tiers employees

Irvine, Ca

•Interface with senior management to communicate / report progress and receive strategic updates impacting the projects.•Develop holistic and detailed plans and roadmaps for successful project execution.•Provide oversight for all projects within the scope of responsibility.•Actively contribute to identification of projects in alignment with the site’s strategic goals and objectives. •Implement necessary project management tools for resource loading, project tracking and problem escalation process for the department.•Optimize project ranking and resource allocation using the established tools in order to establish priorities.•Organize and lead multifunctional project teams to ensure timely implementation of sub-tasks and ultimately the project. •Lead or participate in appropriation of funds for projects.•Closely monitor progress vs. plan and take action as required to keep project on track.•Provide input to solve complex problems including, but not limited to those related to process, equipment, material, supply chain, documentation, equipment validation, IQ/OQ/PQ, ERP, PLM, and other applicable QMS / business processes.•Provide technical leadership for the projects. Lead and coordinate activities of engineers and technicians in support of process and equipment development, process trouble shooting, and custom equipment procurement.•Prepare, review, and approve manufacturing instruction, protocols, reports, and other controlled documentation.•Lead and participate in documented vs. actual gap analysis activities.•Participate in resolution of Non-Conformances and Corrective and Preventive Actions (CAPA).•Perform and present capacity analysis for existing and projected scenarios as well as propose creative solutions to solve difficult capacity constraints.•Supervise and mentor engineers, technicians, and other tier employees.•Participate in self and subordinate’s Performance and Career Development process

Santa Rosa, California

Santa Rosa, California

• Create proof-of- concept processes to complement R&D Engineering through product iterations.• Actively participate in the new product development teams and lead process characterization and process risk analysis activities in the development or improvement of manufacturing processes and support the drafting of documentation including operating instructions and device history records. • Provide day-to-day technical support for Prototype/Pilot Manufacturing Operations.• Review product designs and manufacturing processes for the purpose of improving quality, reducing cycle time and controlling costs.• Identify and develop new robust process technologies to meet our existing and future business needs.• Recommend design modification and implements process changes early in the design phase of products to conform to production capabilities/limitations and minimize cost for production.• Provide technical support in transfer of manufacturing lines to other Medtronic facilities.• Assist in production scale-up of new products and solving related production issues as well as project planning and execution. • Design and implement all special production machinery (jigs, tools, fixtures, machines, and handling equipment) to maintain manufacturing operations at competitive levels.• Develop sequence of manufacturing operations, takt time and yield requirements• Identify opportunities for reducing process variation, automation versus manual operation.• Develop strategy to generate Design of Experiments (DOE), Process characterization, Process Qualification, and Validation Protocols/Reports, Manufacturing Instructions.

• Tutor students in Math, Algebra through Calculus.• Develop lesson plans as well as worked with parents to best instruct the child.

United States

New Product Introduction• Work with other departments on the transition into manufacturing of new products and product revisions.• Conceptualization and development of manufacturing process and equipment.• Review and create product documentation.• Ensure compliance to design control requirements as well as company policies and participate in material review board meetings and disposition of non-conforming material.Maintenance of Existing Product Lines• Troubleshoot new and existing equipment in assembly area.• Manage the preventative maintenance of manufacturing equipment.• Develop and improve production processes for both new and existing products using knowledge of a wide variety of assembly techniques.• Work with external suppliers and customers• Train and provide work directions to technicians and assemblers.Quality Assurance• Improve product quality and reduce product costs, analyze and resolve manufacturing and supplier technical problems and provide engineering support for the manufacture of all products.• Identify and implement corrective actions• Lead investigations and evaluations of product failures and complaints.

•Manage complex product conceptualization, development, and design for High Performance Liquid Chromatography instruments.•Leverage the interchangeability and capabilities of various designs to lead the engineering effort from product conception through launch.

• Perform thermal analysis of consumer electronics products using CFD software• Assist with solid modeling using Solidworks and ProE

• Assisted in design of a mechanical simulator representing typical loading on the human spine.

• Scanned and analyzed the mechanical properties of bones in both mouse and human specimens.• Used both microCT and Fourier transform infrared (FTIR) spectroscopy.

• Assisted in the testing, collection and analysis of rotary actuator data.• Performed analysis of data trends for various test procedures.

Master Of Science - Ms, Mechanical Engineering

Activities and Societies: Berkeley Innovation

Bachelor Of Science - Bs, Mechanical Engineering