The company is looking to solve complex technical and business matters in product improvements through established design control processes and good engineering practices.
Requirements
- Understanding of strength of materials, automation, plastic injection molding, part assembly, fixturing, testing, and process control techniques
- Solid works to interpret part dimensions, sectional views, conduct mates & build assemblies. Able to run basic simulations.
- Risk Management, FMEA generation and Risk Analysis
- Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.) - use of Minitab Software for analysis
- Knowledge of the Medical Device Industry and familiarity with FDA QSR regulations
- Has mastered best practices. Has an advanced understanding of engineering discipline
- Expert in your domain of expertise. Familiar in other areas of domain expertise within the team.
Responsibilities
- Analyze, plan, organize and complete projects of a very complex nature. Develops scope and provide creative solutions.
- Initiate and manage projects with adherence to program management guidelines
- Perform Design assessments, active participation in Design reviews, Risk Management processes.
- Own and manage CAPA tasks and deliverables (Corrective and Preventive)
- Coordinate efforts with the Materials Group to assess vendors and provide materials technical information
- Represent Product Engineering to identify possible product modifications to improve manufacturability and impact on automation equipment
- Maintain Product specifications; consult with manufacturing on product non-conformance.
Other
- Must be at least 18 years of age
- Bachelor’s degree from an accredited college or university (Engineering or Technology)
- 7+ years’ experience
- Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
- Must be able to occasionally move and lift objects of up to 25 lbs