10 jobs found in Aliso Viejo

Job Description Responsible for leading and managing complex packaging engineering projects in medical device product development, production, and sustaining activities. Duties include creating, verifying, and maintaining packaging specifications; developing and validating sterile and non-sterile packaging systems; supporting packaging process improvements; and ensuring packaging designs, materials, and processes meet functional, regulatory, and quality requirements. Provide technical leadership, mentor engineering teams, and collaborate cross-functionally to resolve packaging and production issues and to continuously improve packaging systems and processes. Job duties: Lead and manage packaging development, improvement, and transfer projects for new and existing medical device products. Support sterile and non-sterile packaging systems for new products, product changes, line extensions, and sustaining engineering activities. Develop, review, and maintain packaging...

Job Description Support product data process development of products for medical devices through the creation and maintenance of digital product processes, testing enterprise systems and business processes, maintaining software validation documents and specifications, testing enterprise systems and business processes. Work closely with Operations, R&D, Quality, Regulatory and IT to optimize engineering processes, integrate digital tools, and enhance data continuity from concept through end-of-life. Job duties: Support validation of enterprise system and business processes. Collaborate with fellow associates and other departments to solve product data and process issues. Investigate product process issues in data systems. Troubleshoot PLM-related issues and provide user support. Support data management for pilot production, product development, sustaining engineering, and planning. Execute validation of product and process systems and data. Support organizational...

Job Description Perform small to medium sized and intermediate complex aspects of product/process development. Based on new product concepts and designs from engineers, support the development of products/processes for medical devices, including writing or verifying specifications and/or manufacturing procedures, designing fixtures and new products, and testing processes, equipment, and raw materials to ensure concepts and/or prototypes meet product/process development requirements. Job duties: Technician Role: Perform set-up and testing of completed units or components under operational conditions to investigate designs or to obtain data for development, quality, or manufacturing. Record and analyze test results data using basic statistical tools, with input from engineering staff. Write test protocols and reports, with input from engineering staff. Set up, adjust, repair, and operate laboratory equipment and instruments, which may include electrical wiring and other...

Job Description Support development of medical device products with work including writing or verifying specifications; designing new products and fixtures; testing processes and equipment; and specifying raw materials to ensure the concepts and/or prototypes meet their requirements. Job duties: Develop new product concepts and products. Provide engineering design and process development. Generate intellectual property; write invention disclosures. Supervise Assemblers, Technicians, and Specialists. Largely self-directed and capable of meeting project goals with moderate supervision. Some travel required. / Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization. / Perform additional duties as assigned. Qualifications Bachelor's degree in engineering or Scientific field. Minimum of two (2) years of...

Job Description Support development of medical device products with work including writing or verifying specifications; designing new products and fixtures; testing processes and equipment; and specifying raw materials to ensure the concepts and/or prototypes meet their requirements. Job duties: Develop new product concepts and products. Provide engineering design and process development. Generate intellectual property; write invention disclosures. Supervise Assemblers, Technicians, and Specialists. Largely self-directed and capable of meeting project goals with moderate supervision. Some travel required. / Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization. / Perform additional duties as assigned. Qualifications Bachelor's degree in engineering or Scientific field. Minimum of two (2) years of...

Job Description Support the design and manufacture of medical devices, including creating 3-D designs using a design software such as SolidWorks, generating detailed 2-D drawings, writing engineering requirements, developing test methods, designing test fixtures, supporting product manufacturing, and solving issues through design, development, design transfer launch, and post market phases. Work closely with R&D counterparts, Operations, Quality, and Regulatory in supporting the development of new products and manufacturing processes to achieve a smooth, successful transfer to Manufacturing Engineering and Production for launch and continue supporting product sustainment. Job Duties: 1. Work in cross-functional teams to identify customer needs and develop system requirements, specifications, designs, and drawings to meet these needs 2. Ability to translate abstract ideas into design solutions using variety of methods including but not limited to simple hand sketches, 3D...

Job Description Support development of products and/or product engineering for medical device with work including writing or verifying specifications; designing new products and fixtures; testing processes and equipment; and specifying raw materials to ensure the concepts and/or prototypes meet their requirements. Job duties: Develop new product concepts and products by applying various engineering disciplines, such as mechanical, electrical, materials, bioengineering, or other relevant fields. Provide engineering design and process development, and/or sustain engineering support. Develop products or processes, or the capabilities to support them, such as test methods, equipment/fixtures, data engineering, statistics, software coding and application, engineering/business intelligence, or various analytical methods, etc. Generate intellectual property; write invention disclosures. Largely self-directed and capable of meeting project goals with minimal supervision. Lead...

Job Description Manage individuals from entry-level to junior-level experience, develop and launch products, research new ideas, and manage overall design history. Focus is on both theoretical and practical solution development through the application of the scientific process and project management. Job duties: Manage a group of individuals of varying technical experience from entry level to junior level on projects of defined scope and diversity. Direct subordinates toward clear company objectives in an efficient and effective manner. Collaborate cross functionally with Associates across all departments in R&D, Operations, Quality, and Regulatory Affairs to achieve company objectives and resolve project issues. Manage multiple large-scale project(s) and/or multiple smaller scale projects and timelines without guidance. Independently manage project and timelines using established project management methodology. Communicate project status and issues in a timely,...

Job Description Support manufacturing process development and manufacturing of products for medical devices with work including writing or verifying specifications; maintaining product processes; designing fixtures; and testing processes, equipment, and raw materials to ensure the concepts, sub-assemblies, finished products, and/or prototypes meet requirements. Work closely with R&D, Quality, and Regulatory in supporting the development of new products and manufacturing processes to achieve a smooth, successful transfer to Manufacturing Engineering and Production for launch. Job duties: Improve, sustain, develop, and support of new and existing manufacturing processes for new and existing products, product changes and enhancements, as well as related tooling and fixtures. Support validation of product, equipment, and processes. Interface with other departments to solve production problems. Monitor equipment maintenance program. Investigation and testing of product...

Job Description Perform medium sized and intermediate complex aspects of product/process development. Based on new product concepts and designs from engineers, support the development of products/processes for medical devices, including writing or verifying specifications and/or manufacturing procedures, designing fixtures and new products, and testing processes, equipment, and raw materials to ensure concepts and/or prototypes meet product/process development requirements. Job duties: Technician Role: Perform set-up and testing of completed units or components under operational conditions to investigate designs or to obtain data for development, quality, or manufacturing. Record and analyze test results data using up to advanced statistical tools. Write test protocols, reports, and justification documents for regulatory submissions. Set up, adjust, repair, and operate laboratory equipment and instruments, which may include electrical wiring and other components....