Senior R&D/QA Engineering Technician

Job Overview:

Pay Range: $28.83hr - $33.83hr

Requirement/Must Have:

• H.S. Diploma or equivalent.
• 3-5 years of experience required.
• Foundation in laboratory testing and inspection.
• Basic understanding of medical device inspection or testing concepts.
• Ability to perform hands-on testing and operate laboratory or inspection equipment.
• Ability to interpret and follow testing procedures and instructions.
• Strong verbal and written communication skills and the ability to work effectively with engineers and technicians.
• Excellent computer skills required, including experience with MS Office Suite.
• ERP/MRP systems experience preferred.
• Knowledge of and adherence to the Environmental Health and Safety and Quality guidelines as they relate to department medical device manufacturing.
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment.
• Strict attention to detail.
• Ability to provide feedback in a professional, direct, and tactful manner.
• Must be able to work in a team environment and with minimum supervision.
• Proven success adhering to project schedules and managing small projects.
• Substantial knowledge of validation and improvement of automated equipment.
• Ability to troubleshoot manufacturing equipment.
• Knowledge of material compatibility in the proposed use environment.

Responsibilities:

• Consult with Engineers, Technicians, and Assemblers on processes to execute experiments and/or production runs.
• Support related to equipment investigations, testing, objective evidence of product dispositions and rework support work necessary.
• Review documentation and take appropriate actions to ensure that information is appropriately catalogued and follow through to validation and qualification of equipment.
• Transfer information to appropriate locations, e.g., ECRs, SOPs, drawings, and tooling, for Engineering approval.
• Utilize manufacturing software (e.g., JDE, QMS, PLM) to update documentation in systems.
• Follow through with development of training and documentation materials, based on collaboration with Engineering.
• Identify opportunities for modification and making recommendations, enabling the seamless knowledge transfer of project and manufacturing processes.
• Apply knowledge of processes to devise process changes in collaboration with Engineering.
• Lead projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions and rework.
• Identify potential improvement opportunities and propose solutions to optimize process and/or equipment, e.g., re-design/design of basic equipment, tools, fixtures, etc.
• Provide coaching and guidance to technicians.
• Set-up and execute feasibility studies, experiments, and tests - both creating and following established protocols.
• Analyze results, make recommendations, and develop reports for Engineering review.
• Operate a variety of test equipment to assess characteristics of the manufacturing environment.

Nice to Have:

• Manufacturing or prototype experience when combined with relevant testing aptitude.
• Dimensional measurement, Keyence, or GD&T exposure.
• Tensile or similar mechanical testing experience.

Skills:

• Laboratory testing.
• Medical device inspection.
• QA/QC.
• Visual inspection.
• MS Office Suite.
• ERP/MRP systems.
• JDE.
• QMS.
• PLM.
• Good Manufacturing Practices (GMP).
• Good Documentation Practices (GDP).
• Equipment validation.
• Troubleshooting.

Qualification And Education:

• H.S. Diploma or equivalent.

Physical Requirements(Due to nature of job, The candidate must have):

• Ability to work onsite every scheduled workday.
• Ability to perform repetitive push/pull activity.
• Ability to apply approximately 5 25 pounds of force.
• Ability to perform hands-on laboratory and testing work.