This Senior Engineer is responsible for overseeing outside vendors in the design, fabrication, and qualification of plastic injection molds. Plans, schedules, coordinates and executes all phases of engineering work associated with mold supplier validation. Primarily works independently with instructions as to general results expected. Work closely with Suppliers during development and validation phases. Collaborate with project teams to develop high quality, reliable manufacturable injection molded parts. Provide recommendations on production process, methods and controls.
- Defines required Supplier Process Validation steps, including but not limited to IQ, OQ, PQ, FAI, Gage R&R, DOE, Process Capability Studies, FMEA, Control plan.
- Monitors Supplier Tool development and approves final Tool.
- Approves Supplier Validation Protocols and Conclusions
- Assist Supplier Tool and Molding personnel with troubleshooting design and process issues
- Coordinates cross functional approval with Quality, Engineering and Operations
- Create and submit Change Orders associated with Validation activities.
- Good understanding of mold simulation tools and can adequately communicate molding needs to supplier
- Understands component requirements to properly communicate technical needs to supplier
- Participates in new program quoting, mold design reviews, and formal print reviews
- Provides technical support for molding expertise
- Familiarity with Statistical Process Control (SPC) techniques and Design for Manufacturability (DOE)
- Prepare reports, technical memoranda
- Maintains a good engineering notebook
- Translates the demands of the project or programs into specific engineering tasks
- Prepares and is accountable for schedules for assigned tasks
- Maintains and increases technical competence in his/her field
- Assists others in his/her section to increase their technical competence as the opportunity presents itself.
- Represents the Company to outside organizations in his/her own area of competence
- Performs other duties as assigned
Internal Networking/Key Relationships:
- May assist engineering management in overall program planning
- Work closely with other engineering disciplines
Skills & Capabilities:
- Continuous improvement tools, Six Sigma.
- General knowledge of statistics, including application of capability studies and working knowledge of Minitab Software
- Strong knowledge of mold design
- Demonstrated plastics engineering experience
- Strong Written and Verbal Communication skills, teamwork and organizational skills.
- Bachelor’s degree in Engineering, Science or a related field
- Eight years of product development or relevant experienceFour to six years of product development or relevant experience for advanced degrees
- For internal candidate promotion: Demonstrated proficiency in meeting all competencies of current level and acceptable performance history may be used in lieu of experience
- In vitro medical device experience highly desired.
- Language: Proficiency in English language required
- Not Required
- Some domestic and international travel may be required.
If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.