Communication Skills, Computer Skills, Data Quality, Datasheets, Detail Oriented, Documentation, FDA Requirements, ISO (International Organization for Standardization), Insurance Documentation, Laboratory, Laboratory Techniques, Manufacturing, Manufacturing Equipment, Manufacturing Methods, Manufacturing/Industrial Processes, Mathematics, Medical Equipment, Minitab, PC Software, Physical Demands, Presentation/Verbal Skills, Process Development, Product Development, Product Engineering, Product Testing, Quality Assurance Methodology, Quality Control, Regulations, Research & Development (R&D), Root Cause Analysis, Safety Compliance, Safety Process, Statistics, Team Player, Technical Writing, Test & Measurement Equipment, Testing, Writing Skills
Job Title
Position Summary: This position assists with engineering activities and performs tasks associated with those activities.
Minimum Qualifications: This position requires:
- Associate's Degree in science, math or engineering, progressing towards a 4 year degree,OR
- Minimum of four years related experience
The incumbent must demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities. Must have - Lab Experience - Attention to detail, working with data sheets, documentation Nice to have - Medical Device experience
Essential Duties & Responsibilities: The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.
- Assists in the generation of formal test protocols and reports.
- Assists in the execution of test protocols and procedures. Sets up and operates test equipment and records measurements with limited supervision.
- Maintains accurate data and organizes and presents data in a reportable format.
- Provides process/test method training to manufacturing/QC personnel.
- Develops and maintains a working knowledge of Client policies and procedures and ISO and FDA requirements.
- Expedites and tracks Development Builds through documentation and manufacturing processes.
- Must be able to work in a biohazard environment and comply with safety policies and procedures outlined by Client policies.
Knowledge & Skills:
- Proficiency in personal computer software, especially Minitab and Excel.
- Ability to work in a team.
- Good communication skills (written/verbal).
- Ability to integrate written and verbal instructions; work under supervision.
- Basic organizational and math/statistics skills.
- Basic knowledge of standard laboratory practices.
- Ability to collect, record and report data accurately. Detail oriented.
- Technical writing proficiency.
- General aptitude with testing and manufacturing equipment.
- Task oriented.
Quality Focus:
The incumbent is responsible for assisting in system assurance including documentation, testing and inspection, product and process development, and non-conforming product investigations. Will assist in the support of Manufacturing, New Product Development and Regulatory to ensure systems are in compliance with all internal and external guidelines. Will also work on product failure and root cause investigations.
Research and Development Focus:
The incumbent is responsible for assisting in concept generation, design, development and evaluation of new products, materials and technologies.
Physical Requirements: This position is in an office and laboratory environment and requires the incumbent to sit, stand and perform general office functions. The incumbent may also be required to lift up to twenty five pounds occasionally. The incumbent may be required to stand for extended periods of time. Bending, stooping and reaching are also frequently required.