- The Injection Mold Tool Design Engineer will be expected to determine and generate the information and requirements needed for the design, manufacture, modification and maintenance of tooling equipment within the drug delivery systems area, as well as supporting other areas of Manufacturing Engineering where appropriate. The position is expected to have general understanding of injection mold manufacturing and process principles and working alignment with Quality Control and Quality Assurance, Site Controlling and Operations.
- The role is primarily responsible and accountable for mold design and production and related components ensuring customer specifications are met and they meet appropriate quality standards.
- The role is instrumental in managing the tooling vendor to mold specifications, production, delivery, and maintenance.
- Contributes effectively to procedures and guidelines as necessary in order to maintain a high level of applicable standards as evidence by safety result.
- Area is responsible for producing both internal and external products. The role must have a focus on building strong relationships with internal teams, customers and vendors that facilitate communication, alignment, and customer satisfaction.
- Relevant details provided in a timely manner for issue communication/escalation to the involved parties.
- Strategic continuous improvement plans communicated and aligned on with customer, as well as key area/product performance data and information.
- Able to take a part model from customer through to develop a complete mold design.
- Able to problem solve working with Toolmakers, Process Engineers and Quality
- Must have a working knowledge of plastic injection molds.
- Experience in managing vendors for timely and accurate delivery of mission critical tooling
- Proficient is CAD software specifically Solid Works.
- Able to analyze plastic part models for moldability of part, proper draft required for shutoffs, proper draft required for textures and polished finishes.
- Understanding the classifications of molds. Class 101, 102, 103, etc.
- Able to DFM (design for manufacture) so the mold makers are efficient in their machine operations.
- Able to overlay part models to analyze and describe differences for engineering changes.
- Able to create 2D drawings from mold design when needed.
- Knowledge of Solid Works mold flow a plus.
- Knowledge of hot runner systems and their manufactures.
- Able to work in a fast-paced environment.
- Understanding of automation and controls and able to program and operate CNC equipment a plus.
- Work with cross functional team to ensure that the area practices and procedures comply with all safety requirements promoting a Safety-First culture striving for an injury free workplace.
- PPE such as Safety glasses, safety shoes, gloves, and gowning required in designated areas.
- Gowning may be required in some production areas to ensure integrity of classified area.
- Tasks may include standing, walking, bending, and sitting
- Internal QMS training
- Relevant training on use of IT tools (i.e., ERP, Office, company applications)
- SPC, process controls, metrology (GD&T), Gage R&R, Calibration
- Certifications such as ASQ CQE, CQA, CQM desired
- Job is located onsite in professional offices with a daily presence within the manufacturing area.
- Some travel 5-10% may be required to other internal manufacturing or customer sites in order to effectively drive alignment or provide site support.
- Some work may be required in an ISO 7 or 8 clean room environment.
- Off-shift support may be required periodically to meet business needs
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Injection Mold Tool Design Engineer - Fishers, United States - Vitalent
Description
INJECTION MOLD TOOL DESIGN ENGINEERFishers, 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 an Injection Mold Tool Design Engineer for a key industry partner, Stevanato Group. The Injection Mold Tool Design Engineer will be responsible for tool design, tool management, tooling vendor management and key interactions with process engineering and quality to ensure effective tooling design and act as the subject matter expert in tooling design based on product specifications and to ensure maximum quality, elimination of waste and manufacturing efficiency.
QUALIFICATIONS:
EDUCATION, EXPERIENCE, SKILLS & TECHNICAL COMPETENCES
Education and/or Experience
•Bachelor's degree in mechanical or plastics engineering and injection mold design or 10 years equivalent job experience required.
•5 years minimum in a tool / mold design, and injection mold manufacturing environment.
•Solid understanding of Design for Manufacture principles and analysis
•0-3 years' experience in pharma or medical device industry or a highly regulated environment.
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 skillsAbility to learn new technology and strategies.
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.
•Proficient in Microsoft products including PowerPoint, Excel and Word.
ESSENTIAL JOB FUNCTIONS & RESPONSIBILITIES:
INJECTION MOLD TOOL DESIGN ENGINEER
SAFETY
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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