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Process Engineer - Fishers, United States - Vitalent
Description
PROCESS ENGINEER – INJECTION 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 Process Engineer – Injection Molding for a key industry partner, Stevanato Group. The Process Engineer will be responsible for 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 the assigned area.
ROLE INTRODUCTION
• The Process Engineer – Injection Molding will be part a of the Process Development team for Drug delivery system and In Vitro Diagnostic (DDS&IVD), an experienced and growing team of medical devices engineers that leads the development of proprietary devices and CMO for Stevanato Group
• The position will work in a fast-paced, international and multi-disciplinary team within an entrepreneurial environment where it is possible to transform good ideas into real products
• The role will lead all activities related to process design specific to product manufacturing parameters.
• The Process Engineer – Injection Molding is the technical point of contact for the injection molding manufacturing processes for internal (Tooling Design Engineer, Project Team, QA/RA, Manufacturing Site, Product Management, Business Development) and external stakeholders (Contract Development Organizations, clients, suppliers).
QUALIFICATIONS:
Minimum Qualifications
• 5 years of experience in mold design of high precision and cosmetic molds
• Excellent knowledge of thermoplastic polymers and elastomer
• Familiarity with injection molding simulation tools (filling and warpage analysis), results interpretation and reporting
• Familiarity with validation processes and risk analysis
• Good knowledge of CREO/Solidworks or equivalent CAD system.
• Fluent in English. Fluency in German is a plus.
Preferred Qualifications
• Prior experience in Medical device and drug delivery devices
• Knowledge of regulatory and standard guidelines such as: ISO 13485
• Good understanding of the main process validation methodologies (process analysis for the best parameters identification and set up, process window study and optimization, DOE, cosmetic and functional process, failure analysis and problem solving).
Skills
• Excellent oral and written communication skills; must be able to effectively interact with internal and external customers.
• Strong problem solving and analytical skills with attention to detail.
• Ability to guide strategic prioritization of activities within department.
• Exceptional organizational and multi-tasking skills. Highly organized and can professionally manage and motivate internal cross-functional teams.
• Strong technical writing and technical leadership skills
• Ability to make and drive interdepartmental decisions while influencing external departments.
• Strong project management skills
Technical Competences
• Knowledge of applicable regulatory standards such as ISO 9001, ISO 13485 and applicable FDA, cGMPs desired but not required.
• Knowledge of technologies and control strategies for relevant manufacturing processes in a medical device and/or pharma industry desired.
• 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.
ESSENTIAL JOB FUNCTIONS & RESPONSIBILITIES:
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. Stevanato Group is unable to sponsor or take over sponsorship of an employment Visa at this time.
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