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R&D Product Development Specialist
2 months ago
Company Overview:
Quantimetrix is a reputable family-owned enterprise specializing in the design, development, and manufacturing of clinical laboratory quality controls. With nearly five decades of experience, we pride ourselves on delivering exceptional products and services to the medical sector.
Position Summary:
We are seeking a qualified individual to fill the role of Research and Development Associate within our innovative team. This position focuses on supporting the development of new laboratory quality control products as well as managing the lifecycle of existing products post-launch. The R&D Associate will be expected to execute tasks independently with minimal oversight.
Key Responsibilities:
- Conduct feasibility studies, design characterization, and verification and validation testing for new product initiatives.
- Plan, source, and oversee the materials necessary for research activities.
- Prepare test protocols and comprehensive reports.
- Analyze data and summarize findings effectively.
- Assist in the transition of new products to the manufacturing phase.
- Provide technical assistance for regulatory submissions and post-launch registrations.
- Support post-launch activities including complaint investigations, corrective actions, and product enhancements.
- Maintain laboratory instruments and equipment, contributing to routine laboratory upkeep.
- Undertake additional responsibilities as required.
Qualifications:
- A minimum of 2 years of experience in a medical device environment, with a preference for knowledge in design control and cGMP.
- Proficient in drafting technical documentation.
- Strong analytical and technical skills.
- Detail-oriented with a proven ability in troubleshooting and problem-solving.
- Excellent writing and communication abilities.
- Familiarity with Microsoft Word, Excel, and PowerPoint.
Educational Requirements:
Bachelor's degree in biochemistry, chemistry, clinical chemistry, or a related discipline.
Contract Duration:
This is a contract position with a duration of 6+ months, with the possibility of extension.
Available Positions:
There are 2 positions available for this role.
Compensation:
The hourly pay for this position ranges from $25 to $35, with variations based on experience, skills, education, certifications, and other relevant factors.
