Sr Engineer

Responsibilities

• Demonstrate working knowledge of basic technical theories and principles.
• Assess feasibility of simple research and design concepts.
• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Develop plans to verify and/or validate a system.
• Develop test methods to explore design options and challenge requirements of apheresis devices and cell processing equipment.
• Execute tests of apheresis devices and cell processing equipment at the system and subsystem level.
• Record data with good documentation practices, including making observations.
• Analyze data and interpret and document results.
• Generate clear and detailed technical documentation, including plans, reports, execution, and results of tests or studies.
• Manage traceability and versions of test objects: plans, requirements, test objectives, test scripts, test case records, and system issues.
• Investigate issues to determine root cause using established problem-solving tools.
• Set up and maintain test articles, test fixtures, and laboratory environment.
• Prepare blood for testing and characterize blood components after processing.
• Participate in Risk Management activities.
• Participate in Usability Engineering activities, such as formative and summative studies.
• Interface effectively with product development teams and technical support groups.
• Work under general supervision with latitude for independent judgment.
• May consult with senior peers on certain projects.

Qualifications

• B.S. or M.S. degree in Engineering (systems, biomedical, electrical, mechanical, or similar engineering discipline) with 2+ years related experience.
• Basic skills with moderate level of proficiency.
• Must possess a firm foundation in the basic principles of their respective engineering discipline.
• Previous experience with Medical Device Development preferred.
• Familiar with appropriate FDA QSR regulations, design controls, document controls, and overall medical device industry knowledge.
• Experience with systems engineering tasks such as Requirement Management, Usability, Verification and Validation.
• Ability to diagnose and solve problems involving multiple technologies (i.e. mechanical, electrical, software).
• Ability to work with a cross-functional team, as well as independently.
• Task management skills with ability to prioritize multiple assignments.
• Orientation to details, natural inclination to be methodical and hands-on in a development lab environment.
• Familiarity with biological laboratory processes preferred.
• Proven capability in laboratory work, data analysis, system testing, and test design.
• Strong organizational, interpersonal, written, and verbal communication skills.
• Strong critical thinking skills and the ability to function in a sometimes-ambiguous situation.
• Ability to guide and direct the activities of a technician or co-op.