Senior Manufacturing Engineer
Senior Manufacturing Engineer works as part of a multi-functional team in the development and production of medical devices used for the treatment of stroke. They provide production, process, and risk management support to ensure that our medical devices are appropriately designed and manufactured to successfully treat ischemic stroke.
This includes providing technical expertise within the manufacturing engineering team tasked with the production of acute ischemic stroke devices. Production support activities such as equipment validation, process validation, risk assessments, and management of the manufacturing line performance at our external manufacturer are core to the role.
Responsibilities
- Identify and implement opportunities for improved efficiency. Proactive monitoring of line efficiency, performance and output using Lean / Six Sigma methodologies.
- Drive process/product improvements (design for manufacture/design for assembly) related to external manufacturer
- Establish relationship with external manufacturers ensuring production targets are achieved.
- Monitor external manufacturer performance and provide technical support to resolve issues.
- Completion and review of process risk analysis and ongoing dedication to risk reduction.
- Provide design for manufacture feedback/support to R&D team during new product development phase.
- Equipment specification, procurement, calibration, and maintenance.
- Collaborate closely with component and service suppliers as required.
- Apply advanced statistical methods and performs mathematical calculations to resolve manufacturing processes, staff requirements, and production standards.
- Apply verbal and written communications skills in periodic and special reports and presentations both internally and with customers.
- Perform analytical problem solving/process improvement projects and utilizes structured decision-making skills.
- Give technical mentorship to junior engineers/technicians.
- Represent the company externally, for example at physician line tours.
Requirements
- Mechanical or biomedical engineering degree or equivalent.
- Minimum of 5 years’ experience of medical device process or design and development experience in a regulated environment.
- Prior experience in medical device catheter process design and/or manufacturing.
- A strategic team-player, with deep-rooted initiative and accountability.
- High level of technical writing and reporting skills.
- 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.
- Ability to multi-task, working on multiple projects simultaneously.
#LI-MS2