The Senior Manufacturing Engineer I -New Product Introduction, will lead the transfer of new products and processes into Manufacturing Operations. In addition, the Manufacturing Engineer will work on process/product improvements and contribute to the investigation of technical issues in manufacturing to ensure continuous improvement.
The individual should have at 7+ years of engineering experience in a manufacturing facility, have familiarity with CAD software and strong documentation skills.
Essential Responsibilities: The employee may be required to perform all or a combination of the following essential responsibilities as determined by business necessity.
- Lead NPI builds to ensure smooth transfer of knowledge to production team and provide training to personnel on new products/ processes as necessary.
- Engage with cross functional design engineering teams to transition new products into manufacturing
- Support the development of new products by driving design for manufacturability, including of materials cost, ease of manufacturability, reliability, and serviceability with a particular focus on the electro-mechanical assemblies.
- Measure/inspect electromechanical components for form, fit, and function and disposition nonconforming product.
- Update/create manufacturing documentation which conform to Quality System Regulations (QSR's) and ISO standards.
- Research, specify and procure new equipment for existing or new processes/assemblies. Design and construct tooling/fixtures for processes or modify existing production equipment as needed.
- Write and execute Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Validations, Design of Experiment (DOE), Process Failure Mode Effects Analysis (PFMEA) and Continuous Improvement Studies/Evaluations.
- Examine and implement lean manufacturing techniques.
- Perform robust root cause analysis of production issues, implement appropriate containment, and drive corrective action.
Non-Essential Responsibilities: In addition to the essential responsibilities listed above, the employee may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor.
Interested? Here's what you do next:
If this position has captured your interest and you are excited to learn more, please apply now and the appropriate TCML Recruiter will be sure to reach out to you soon!
Equal Opportunity Employer Veterans/Disabled.
- Bachelor's Degree in Mechanical or Electrical Engineering
- 7+ years of manufacturing engineering experience in a regulated industry; medical device experience is helpful
- Experience utilizing SolidWorks for design
- Knowledge of QSR and ISO regulations is a plus
- Good written and oral communication skills, including ability to communicate effectively at all levels of the organization
- Works well in a team, proactive, thrives in fast moving environment
New Product Development
Continuous Improvement Process
Quality Management Systems