- Minimum bachelor's degree in engineering
- 3-5 years' experience in plastic injection molding process
- Mold design knowledge
- CAD/CAM knowledge
- Familiarization with automation
- Lean manufacturing knowledge
- Experience in Quality Assurance, Quality Engineering, or Process Engineering preferably in the medical device industry.
- Knowledge of applicable regulatory standards such as ISO 9001, ISO 13485 and applicable FDA cGMPs
- Knowledge of technologies and control strategies for relevant manufacturing processes in a medical device and/or pharma industry
- Knowledge of device manufacturing Quality Management System processes and features
- Extensive knowledge of root cause investigation tools and methodologies
- Extensive knowledge in risk management methodologies, techniques, tools and applications
- Knowledge of metrology and calibration techniques and geometric dimensioning and tolerancing (ANSI Y-14.5)
- Working knowledge of statistical methods used in manufacturing.
- Maps the processes for the relevant areas, identifies gap, analyses causes and areas of improvements, proposing corrective feasible actions, projects, and processes able at solves critical issues in order to bring consistent and effective continuous improvement within the areas in scope.
- Executes effectively the set up plans and achieves agreed milestones and targets, provides the involved functions with inputs to support the operatively execution of operative tasks, provides monthly, quarterly and yearly data analysis and other relevant insights able at supporting the prioritization of decision processes according with the BU's mid-term goals, with the aim of sustain a feasible organizational success and minimization of costs.
- Participates with process engineers and production technicians in the application of continuous improvement and problem-solving methodologies fostering improvement programs, projects and initiatives as well as ensuring timely and cost-effective execution.
- Participate in the user requirement collection phases during the new/revised equipment concepts, development and validation, formalize documents and report required for the investment proposal, working closely with the involved in order to provide all the requirements and analysis needed.
- Provides robust and accurate analysis on yield variances with the aim of identifying causes, proposes corrective actions and relative execution plan, working alignment with Quality Control and Quality Assurance, Site Controlling and Operations.
- Defines and monitors the operation KPI's dashboard highlights critical issues and proposes actions aimed at solving it to the manager above and to the involved functions, ensuring an efficient and effective operatively execution across the relevant areas.
- Monitors the project's progression in term of timing, performances, outcomes delivery and management recovery plans execution in order to ensure the results expected.
- Contributes effectively to procedures and guidelines creation executing the relevant sections, driving the operatively implementation across the functions involved in order to maintain high level of applicable standards as evidence by safety result.
- Deals with the external stakeholders such as industrial players, customers, technical providers with the aim of promote the SG business areas expertise and competitive advantage as well as collect the guidance, standards and trends and transmits them to the relevant functions involved with the aim of ensure the compliance and drive the future development.
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Manufacturing Process Engineer - Fishers, United States - Vitalent
2 weeks ago
Description
MANUFACTURING PROCESS ENGINEER - PLASTIC MOLDINGFishers, IN
ViTalent is a premier professional services organization that specializes in talent acquisition, talent development, staffing, and consulting for Life Sciences and Healthcare. Our business is people Talent is in high demand and our simple mission is to impact lives as a long-term partner for both talent and organizations.
We are currently looking for a Manufacturing Process Engineer - Plastic Molding & Tooling for a key industry partner, Stevanato Group. This position will play a key role in process engineering for a new state of the art facility equipped with advanced process technologies to produce Stevanato Group's EZ-Fill syringes and vials.
The ideal candidate will play a key role in providing solutions to manufacturing areas with improvement needs, in terms of processes, readiness, robustness, efficiency, and effectiveness, implementing activities and corrective actions, in order to ensure maximum quality, elimination of waste and boost efficiency, both in terms of equipment and work procedures, constantly monitoring results and performance targets achievements as well as working alongside with production technicians and continuous improvement team in their assigned area.
QUALIFICATIONS:
1) PROCESS ENGINEERING AND CONTINUOUS IMPROVEMENT EXECUTION
All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Applicants must be authorized to work for any employer in the United States. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
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