Job Description:The Staff Plastics Technical Operations Engineer is accountable for maintaining compliance and leading various technical aspects of new and commercialized plastics consumables. The incumbent would lead projects that require interfacing with cross-functional, cross-site team members such as development, quality, manufacturing, purchasing, and suppliers. These projects may include mfg expansion of commercialized products, transfer of new and enhanced products, major technical investigations, etc.
Responsibilities to include failure investigation of fielded products, resolve technical process and product design challenges, lead process validations for external processes, working with suppliers worldwide, contribute in design reviews and recommendations for manufacturability and assembly, establish and implement manufacturing/ quality controls, provide technical support for internal and external customers as required; participate in the selection of new polymers, processes, equipments, and suppliers.
Responsibilities:Essential Behaviors and Responsibilities include, but are not limited to the following:
- Leadership and teamwork skills to effectively lead and contribute to multi-functional project teams.
- Ability to scientifically resolve technical challenges and negotiate with key stakeholders. Hands on, goal oriented, and creative thinker with focused urgency.
- Ability to apply theoretical and scientific technical principles to product design improvements and enhancement
- Very well developed communication and negotiation skills
- Ability to apply FDA QSR/ISO control regulations to projects which result in meeting FDA/Company guidelines and policies.
- A technical expert in the area of plastics engineering with proven track record.
Experience:- A minimum of a Bachelor's degree in Mechanical/Plastics Engineering or other closely related engineering discipline with 10 years of relevant work experience is required, or a Master's degree with a minimum of 7 years of engineering experience.
- Preferred three or more years of specific experience in plastic component manufacturing for medical devices in ISO, FDA/GMP regulated environment.
- Must possess advance knowledge of plastic tool design and construction, polymer science and commercialized material properties and characteristics, and in-depth understanding of various high volume polymer manufacturing processes.
- Experience in conducting 'Design of Experiments' with expertise in 'Design for Manufacturability and Assembly' for plastic products.
- Demonstrated proficiency in conducting process validation in regulated environment.
- Expertise in use of 6-sigma related statistical tool for various scientific analyses.
- Development experience related to design of new products and tools using CAD packages and simulation analysis such as moldflow
Apply online at:https://recruiter.kenexa.com/bci/cc/CCJobDetailAction.ss?command=CCViewDetail&ccid=bupJEdUjsTs%3D&job_REQUISITION_NUMBER=100634
