Why This Role Stands Out
This hybrid R&D Technician II role offers a fantastic opportunity to contribute to high-quality medical device testing within a collaborative team, fostering your analytical and documentation skills. If you possess meticulous attention to detail and enjoy a dynamic environment, you'll thrive here and grow your career in a reputable company. Apply today to join this impactful team!
Quick Overview
Job Description
Description
Job Purpose
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
- Performs 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 BSC 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 BSC 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 a 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.
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