Lead Engineer – Quality, Design Assurance, Early Stage, Imaging

We are working with a fast-paced medical device start-up developing break through solutions for the diagnosis and treatment of cardiovascular disease. 

Using breakthrough optical imaging technology along with advanced machine learning algorithms, our client company provides life saving insight during cardiac procedures.

This position is On Site  west of Boston vic.  Watertown, Waltham, Arlington, MA

Job Summary

We are seeking a Lead Quality Engineer to provide oversight of quality assurance support and facilitate the application of design controls, risk management and usability for complex electromechanical medical devices that include software and sterile, single-use disposables. The right candidate will have a successful track record of hands-on experience with the development and implementation of processes to design, assess, and monitor new and sustained product development. In addition, this individual will help develop, establish and maintain quality methodologies, systems, and practices to facilitate product development, operations, and related functions to meet corporate requirements.

Key responsibilities

• Provide design assurance support and leadership in the design and development of medical device products.
• Key contributor, advisor and reviewer of verification and validation methods and protocols, test methods, statistical analysis, and specification derivation and assignment.
• Establish, communicate, and control risks for risk management reporting.
• Provide additional Quality Systems support throughout the organization.

Requirements

• Minimum 5 years of experience within a quality role in the medical device industry, with focus on design, development and commercialization of new products and technologies.
• Strong experience with complex medical systems containing software, hardware and disposable.
• Working knowledge of ISO13485, IEC 62304, Medical Device Directive and QSR requirements.
• Working knowledge of risk management standard ISO 14971.
• Experience in working with hazard analyses and risk analysis tools, such as FMEA, and FTA.
• Knowledge of Manufacturing Engineering or Manufacturing Quality Engineering.
• Experience with devices falling under IEC 60601-1.
• Experience supporting regulatory submissions for both clinical and commercial uses, such as IDE, 510(k), or PMA.
• Must be a self-starter and a fast learner, must work efficiently, both independently and within a team, must have very good problem-solving skills and attention to detail.

Education



• Bachelors degree minimum in engineering (electrical or systems or biomedical); Masters degree preferred
• Certifications and expertise related to Quality and/or Regulatory subject matter (i.e. CQE, CQM, CQE, CBA, DFSS, RAC, etc… )