PROCESS ENGINEER - INJECTION MOLDING

Fishers, IN

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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

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.

EQUIPMENT DEVELOPMENT AND ENGINEERING

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.

MONITORING AND REPORTING

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 terms of timing, performances, outcomes delivery and management recovery plans execution to ensure the results expected.

GUIDELINE & PROCEDURES EXECUTION

Contributes effectively to procedures and guidelines creation executing the relevant sections, driving the operatively implementation across the functions involved to maintain high level of applicable standards as evidence by safety result.

RELATIONSHIP MANAGEMENT

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.

If you meet the qualifications and are interested in this opportunity, please complete our online application or for more information contact Lisa at (url removed). We look forward to getting to know you as you consider next steps in your career.

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.