Skilled Product Engineer

Responsibilities:

• Medical device remediation related project responsible for designing, developing, implementing and evaluating optimal, cost-effective projects and technologies.
• Able to contribute to cost estimating of major capital budget items and the spending of approved project funds.
• Ability to prioritize multiple tasks
• Contribute to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a larger project.

Qualifications:

• Minimum requirement Bachelors of Science in Engineering (discipline: Bachelors degree in Mechanical, Biomedical or Chemical engineering. Advanced degree is a plus.)
• 1+ years medical device product development experience
• Knowledge of DHF or DHF Remediation
• Must have experience or advanced training and demonstrate proficiency (e.g. Investigations, problem solving, total quality management, statistical methods, DHF remediation, Risk file remediation, problem analysis and resolution, materials science, design of experiments etc.)
• Good understanding of MDR remediation; extensive cross-functional team experience, including technical and non-technical work.
• Experience with any statistical software package, prefer Minitab
• Nice to haves: CAPA and Change control TW8 system experience

Skills:

• Product Development
• Product Quality
• Medical Device