Job Summary
This role is for a Manufacturing Engineer to join our multi-functional team in the development and production of medical devices used for the treatment of stroke.
Responsibilities:
* Identify opportunities for improved efficiency, utilizing Lean / Six Sigma methodologies for proactive monitoring of line efficiency, performance and output.
* Establish relationships with external manufacturers to ensure production targets are achieved.
* Complete and review process risk analysis, dedicating ongoing efforts to risk reduction.
* Provide design for manufacture feedback/support to R&D team during new product development phase.
* Evaluate equipment specifications, procurement, calibration, and maintenance needs.
* Collaborate closely with component and service suppliers on quality issues.
* Apply advanced statistical methods and perform mathematical calculations to resolve manufacturing processes, staff requirements, and production standards.
* Develop and deliver periodic and special reports and presentations both internally and with customers.
* Pursue analytical problem-solving/process improvement projects, utilizing structured decision-making skills.
* Offer technical mentorship to junior engineers/technicians.
* Represent the company externally, participating in physician line tours.
Requirements:
* Mechanical or biomedical engineering degree or equivalent.
* Minimum 3 years' experience within a GMP regulated Operations Department environment.
* Production/line support experience within a medical device environment.
* A strategic team-player with deep-rooted initiative and accountability.
* Inherent critical thinking and problem-solving skills.
* Working knowledge of six sigma and/or lean engineering principles with a proven track record in use and delivery of results.
* Specific experience in laser-cutting/welding, adhesive bonding, and microassembly of medical devices.
* Experience in technology transfer and process optimization.