Description
Requirements
- Develop concepts and ideas for improving existing tooling as well as creating new tooling including semi-automation where applicable
- Evaluate the current manufacturing processes & workflows, identify opportunities for improved performance/throughput by applying knowledge of product design, fabrication, assembly, tooling, and materials as well as soliciting feedback from operators
- Take full ownership of the design, create User Requirements Specification (URS), conduct concept reviews, show proof of concept through prototyping/supporting test data, coordinate with appropriate stakeholders for successful verification/validation, launch, and documentation
- Create 3D models, engineering drawings and bills of materials
- Create comprehensive work instructions and manufacturing SOP’s
- Create verification/validation protocols (IQ,OQ,PQ), lead/support the execution activities, generate relevant data and provide corresponding documentation and reports
- Participate in design FMEA and plan steps for mitigating risks
- Establish a working relationship with outside vendors, machine shops, contract manufacturers and manage the work accordingly
- Comply with company’s policies and guidelines regarding design control, validation activities and documentation
Education and/or Job Experience
- Bachelor’s Degree in Mechanical Engineering
- 5-7 years hands-on, relevant experience
- In-depth experience with complex mechanical/electromechanical design
- Extensive experience with precision mechanisms, pneumatics, servo systems, tooling/fixtures, and mechanical components such as motors, belts/pulleys, gears, actuators, sensors, etc.
- Experience with creating engineering drawings, BOMs and product specifications
- Deep knowledge of material properties, heat treatment, and surface finish
- Proven track record with Medical Device Manufacturing Methods/Procedures, FDA regulations, ISO, cGMP, and QMS standards
- Good understanding of DFM and lean manufacturing
- Excellent verbal, written, presentation and interpersonal skills
- Strong analytical and problem-solving skills
- Knowledge and/or hands-on experience with machine shop tools
- Deep knowledge of GD&T as well as proficiency with SolidWorks
- Creative, self-motivated and flexible to work in a small company environment and assume a wide variety of tasks
Preferred Qualifications
- Master’s degree in Mechanical Engineering or equivalent
- Knowledge/experience with plastic injection molding
- Knowledge/experience with DOE, SPC, JMP /Minitab
- Experience with metal stamping, laser cutting and chemical etching
- Familiarity with and sterilization process and aseptic environment
- PLC programming