Description
Job Summary:
Responsibilities:
Must haves: minimum 2 years of engineering experience, Solid works, execution hands on role, Engineering Degree
Nice to haves: Statistical Analysis Experience
Test Engineer
Synthesizes requirements and/or design specifications into testing solutions for disposable medical device products 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 of test fixtures and testing of prototypes or developmental assemblies or systems.
ESSENTIAL DUTIES:
Duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Enter Responsibilities/Essential Duties:
- 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 validates moderately complex test methods, executes testing protocols, and incorporates statistics and principals of experimental design.
- Maintains R&D lab organization, calibration records, and performs preventative maintenance of equipment and test fixtures.
- Identifies, procures, calibrates, 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 product development team, suppliers, and other technical and support personnel. Applies and demonstrates understanding of customer needs, product use, and operational requirements to translate customer needs into testing design specifications and applications. Applies basic understanding of specialized and/or interdisciplinary technical areas, project management, and system design.
- Clearly communicates 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.
QUALIFICATIONS:
Required: Bachelor's Degree, BSE in technical field.
Preferred: Bachelor’s Degree in Mechanical, Biomedical, or Materials Engineering.
EXPERIENCE:
Required: 0-4 years’ experience with medical device development under FDA Quality Systems Regulations.
Preferred: Experience with machining and working in machine shop environment is a plus.
Proficiency:
Skills
bsme, solidworks, test methods, test procedure, microscope inspection, tensile testing, vibration analysis, autocad, writing & communication skills, machining equipment, machine shop
Top Skills Details
bsme,solidworks,test methods,test procedure,microscope inspection,tensile testing,vibration analysis,autocad,writing & communication skills
Additional Skills & Qualifications
- Demonstrated written communication skills
- Strong verbal communication and listening skills
- Troubleshooting and problem-solving skills with hands-on practical expertise
- Proficient with lab equipment appropriate to technical field such as microscopes, Instron tensile testers, chemical hood, and noise & vibration analyzers.
- Proficient with Microsoft Word, PowerPoint, Excel, and Minitab.
- Proficiency in design packages appropriate to technical field such as SolidWorks, eDrawings, and AutoCAD is desirable.
Experience Level
Intermediate