The Mechanical Engineer III Manufacturing designs, develops, and tests all aspects of mechanical components, equipment, and machinery related to the development, approval, and manufacturing of an active implantable Class III medical device. This job is structured under manufacturing engineering and is responsible for developing high capability manufacturing processes, as well as improving product design for manufacturability.
Reports to: Engineering Manager
TO APPLY: Send Resume/CV and Cover Letter explaining your fit with this position via email to: careers@physiologicdevices.com.
Duties and responsibilities
- Collaborates with manufacturing to develop, document, implement, and train staff on high-capability manufacturing and test processes.
- Conducts product testing as needed.
- Creates CAD models and prototypes.
- Designs, sources, builds, and debugs fixtures and tooling for manufacturing and product development.
- Analyzes and optimizes manufacturing processes.
- Evaluates and designs components and subassemblies for manufacturability.
- Applies valid industrial research and applied statistics for process control.
- Prepares engineering protocols, executes plan, gathers data, analyzes the results, and writes clear and concise reports.
- Implements basic project management goals, schedules, tracking, and reporting.
- Works within medical device regulations and conforms with the Quality Management System.
- Collaborates with assemblers and technicians to write clear assembly and test procedures and resolve technical issues.
- Participates in structured failure and root cause analysis for issue resolution.
- Develops and executes qualification studies, including verifications and validations.
- Works mostly autonomously but requires direction to accomplish complex projects and tasks.
- Works well in a team setting and interdepartmentally with colleagues.
Qualifications/Education
- Requires a bachelor’s degree of Mechanical Engineering, Industrial Engineering or Manufacturing Engineering or related experience.
- Typically requires 5-7 years of related experience.
- Working knowledge of fluids, especially pumps, and associated test systems. Microfluidics is a plus.
- A background in Lean Manufacturing tools and techniques is a plus.
- Must have good SolidWorks modeling and drafting skills per ASME Y14.5.
- Must be proficient with MS 365 tools.
- Must have good oral and written communication skills.
- Must have experience working within medical device regulations (ISO 13485, ISO 14971, FDA 21 CFR 820) and work must conform with the Quality Management System.