Website LanceSoft Inc
LanceSoft Inc
Company : LanceSoft Inc
Join our dynamic team in North Haven, CT, where you can contribute to shaping the future of healthcare. As a Senior Quality Engineer, you will support new product development for Surgical Instruments. This role involves working closely with a cross-functional core team to drive product quality and continuous improvement.
Top Technical Skills Required
- Risk Management (Hazard Analysis, DFMEA, UFMEA)
- Design Verification Authoring and Execution
- General NPD QE skillset (Change control, CAPA, ISO 13485 understanding)
Position Responsibilities
- Actively participate in the product development cycle by reviewing project documentation, participating in product risk assessments, and developing verification and validation testing requirements.
- Assess overall product risk by facilitating the development of risk management tools such as risk management plans, hazard identification, and complaint analysis.
- Collect, analyze, and interpret statistical data, providing reports to management as required.
- Contribute to Design and Process Validation initiatives by planning and reviewing validation and qualification activities.
- Provide solutions to a wide range of challenges, working independently to develop imaginative and practicable solutions.
Basic Qualifications
- B.S. degree in Engineering, Math, Physical Science, or equivalent field with 5 years of work experience in engineering or Quality.
- Preferred: M.S. degree in Engineering, Math, Physical Science, or equivalent field with 4 years of work experience in engineering or Quality.
Specialized Skills or Experience
- Fundamental understanding of electro-mechanical designs and manufacturing processes.
- Experience in a regulated industry.
- Experience with Minitab or similar statistical analysis tools.
- Good interpersonal skills and ability to work effectively in a team environment.
- Strong attention to detail and ability to prioritize multiple projects.
Nice to Have
- ASQ Certified Quality Engineering (CQE)
- Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 14971, and 60601 requirements.
- Understanding of software and hardware interface.
Join us in North Haven, CT, and be part of a team that is pushing the limits of technology to change healthcare worldwide. Together, we can make a difference.