Synthesizes requirements and/or specifications into mechanical, electrical, plastics, software or system testing solutions that acknowledge technical, schedule and cost constraints in support of R&D product development. Designs, develops and executes comprehensive test plans, procedures, schedules, and test protocols to evaluate the design per specifications. Reviews and evaluates test requirements to insure completeness of test program. Coordinates integrated testing activities including required labor, space, and equipment with appropriate areas or vendors. Provides assessment to engineers, technical lead, or project manager and adjusts plan as required. Compiles data and defines changes required in test equipment, procedures, processes, methods, or new testing requirements. Performs data analysis and documentation of test results. May participate in design, modification, fabrication, assembly and testing of prototypes or developmental assemblies or systems.
• Applies understanding of basic business fundamentals, and how the specialized technology area impacts adjacent technical disciplines. Leverages creative skills with pragmatic understanding of technical and operational goals; executes work with quality, accuracy, and timeliness. Within assigned scope, independently sets technical priorities and acts with, or guides others toward the proper balance of effort vs. timeliness, and technical improvements and innovations with practical business constraints.
• Demonstrates solid/strong technical knowledge to independently select best methods and approaches to solve diverse and moderately complex problems and make accurate and effective technical decisions. Solves complex problems under close supervision or with assistance. Applies appropriate standards, processes, policies, procedures, and tools throughout the product/system development lifecycle, including Standard Operating Procedures (SOP’s) and applicable medical device development protocols under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems.
• Develops and prepares moderately complex test protocols, incorporating statistics and principals of experimental design.
• Develops/expands diversity/global awareness and communicates with cultural sensitivity.
• Identifies and formulates problems, collects data through observation and experiment, and forms, tests, and validates hypotheses. Selects and appropriately uses laboratory equipment and tools, and clearly documents, communicates, and summarizes technical findings and results.
• Implements project management practices as needed; communicate proactively, openly and cooperatively within the department, team, and with supervisory staff to keep all informed. Prepares clear and timely written and oral status reports, updates, and technical presentations. Makes technical presentations to supervisors and small groups and may assist others with presentations.
• Interfaces with customers, suppliers, application users, and other technical and support personnel. Applies and demonstrates understanding of customer needs, product use, and operational requirements to independently translate customer needs into systems testing design specifications and applications. Applies basic understanding of specialized and/or interdisciplinary technical areas, project management, and systems design and integration needs.
• Leads design reviews at the sub-assembly level and may guide the work of support staff; clearly communicating instructions and technical specifications, both orally and in writing.
• Proactively identifies, communicates, and refers problems or coordination needs to senior staff or supervisors. Exercising sound judgment of what to share, refer, and when to seek assistance, provides timely, accurate, and detailed background data to minimize risks or support problem-resolution or goal achievement.
• Works on diverse assignments of moderate complexity. Has responsibility for multiple small deliverables within a single specialization area, or works on parts of larger projects. Responsibility includes definition, completion, technical quality, and securing consistency across assigned area(s).
Required Bachelor's Degree BSE
Required 1 year Related experience
Required Other Experience with medical device development under FDA Quality Systems Regulations
Required Other Equivalent combination of education and experience
Licenses and Certifications:
Preferred CE Marking, and ISO Quality Systems
Candidate Background: Skills, Knowledge & Ability: Minimum requirements:
Required Related experience
Required Experience with medical device development under FDA Quality Systems Regulations
Required Equivalent combination of education and experience