R&D Technician II

Medical Device Particulate Testing Specialist

This individual will work within a high-performance cross-functional team performing routine medical device particulate testing, ensuring delivery of the highest quality results to the customer. We are seeking a highly motivated individual who thrives in a fast-paced environment, with excellent documentation practices, and exceptional attention to detail.

Key Responsibilities:

• Perform routine testing assignments requiring basic interpretation of established procedures.
• Gathers and records data, analyzes results, and verifies and reports test results.
• Assignments require broad judgment in troubleshooting.
• Create and maintain data files and forms.
• Communicate with a wide variety of client personnel in and outside of the plant.
• Identify areas of improvement and participate in continuous improvement projects.
• Use documentation systems to research information and generate Change Requests.
• Assist in developing and qualifying data sheets, equipment/fixtures, visual standards, and test methods.
• Initiate, investigate, and assist in generation and completion of NCEPs and DDAs.
• Assist with product failure analysis.
• Communicate testing results to teams.
• Assist engineers in failure analysis and CAPA activities, including assignment as a CAPA project member.
• Support process and product qualification activities.
• Serve support roles during external audits: Document retriever, auditee.
• Perform "special" quality initiatives with guidance.
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance with the client's Quality Policy and all other documented quality processes and procedures.
• Employ basic analytical lab skills such as reading a meniscus, pipetting, using a balance, using a stir plate, etc.

Basic Qualifications:

• AA Degree or equivalent work experience in related discipline and 3+ years of related experience. • Prior experience in a lab environment including analytical laboratory skills (weighing, pipetting, scientific method, etc.). • Knowledge of Microsoft Office (Word, Excel, Outlook) required. • Must be physically able to lift to 35 lbs. • Must be able to stand for 8 hours.

Preferred Qualifications:

• DV test protocol training and execution experience • Strong problem-solving skills. • Quick learner; willing to learn the current test processes and procedures in a regulated environment. • Able to multitask between projects in different stages of development. • Demonstrated experience analyzing and fulfilling documentation requirements. • Ability to communicate detailed information to the project teams. • Ability to work in a team environment interacting with engineers and technicians. • Prior experience in test documentation through lab notebooks or reports. • Experience in the medical device industry, preferably testing medical devices. • Operate and maintain test equipment. • Chemistry/Biology experience.