Product Development Engineer: Injection Molding & Automation

Vaupell Industrial; Constantine (MI); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

Vaupell Industrial in Constantine, MI is seeking a Program Manager to lead new product introduction activities for large-scale injection molding programs, coordinating design reviews, validation, and automation equipment. The role emphasizes FDA/industry quality standards and cross-functional teamwork to deliver on timelines and budgets.

The position requires a Bachelor's in engineering, 5+ years in program management, and strong knowledge of SIM validations, tool design, and DOE/STAT analysis.

Formación

• Bachelor’s degree in engineering or related field from an accredited institution or equivalent experience or combination of education and experience.
• Five (5) years in a Program Manager role.
• Knowledge of SIM for medical validations.
• In-depth understanding of part design, tool design, materials, processing, and fixtures.
• Knowledge of tool design, hot runner manifolds, valve gate technologies, Mold Flow analysis.
• Experience procuring and validating robotics and automation for part handling, assembly, decorating and packaging of medical device components and subassemblies. Following GAMP guidelines for automation validation.
• Statistical analysis understanding of capability analysis, process centering with design of experiments and utilizing SPC and real time process controls on injection molded parts.
• Design experience related to solid modeling of end of arm tooling or simple automation is desired.
• PLC programming and controls engineering knowledge is a plus.
• Ability to read, speak, understand, and follow instructions in English.
• Must be able to wear and properly use the required personal protective equipment.

Responsabilidades

• Provide Design for Manufacturing (DFM) technical support for customers including.
• Reviews product design for compliance with engineering principles, company standards, and customer contract requirements, and related specifications.
• Leads the creation and analysis of DOEs
• Facilitates NDA’s, contracts, customer documentation and forms as needed.
• Quoting new parts, re-quoting of existing parts, and preparing quote proposals for customers.
• Develop and implement cost reduction ideas and prepare capital expenditure requests that meet company acceptable ROI (Return on Investment).
• Adjusts complaints concerning billing or service rendered, referring complaints of service failures to designated departments for investigation.
• Assisting in closing out CAPAs on an as needed basis.
• Develops key data for customer validation requirements (FMEA, IQ, OQ, PQ, PSW and PPAP submissions).
• Communication/Resolution of all issues affecting customer perception including but not limited to Quality, delivery, tool maintenance requirements, price negotiations, logistical needs, payment terms and EDI requirements)
• Perform activities as they relate to Quality Systems and Regulatory Requirements such as: ISO 9001:2000; ISO 13485:2003; 21CFR Part 820; AS 9100.
• Serve as a project Team Leader providing assigned customers with front line commercial and technical project engineering support including defining and documenting customer requirements, quoting, prioritizing workflow, and assisting in securing new business development opportunities.
• Creates, manages, and maintains schedule,Risk Assessments and Communication Plans for all new product introduction activities at facility.
• Provides production solutions that meet regulatory requirements, approach/exceed LEAN capability, and meet cost/delivery targets.
• Serving as liaison between Engineeringand Operations to review quotes,new business opportunities and to ensure the organization responds to issues in a timely manner.
• Managing tool builds andsupplyingproject timelines.
• Troubleshoot existing issues from process control andtoolingto inspection.
• Follow all Vaupell policies and procedures.
• Other duties as assigned

Conocimientos

Program management

DFM support

DOE analysis

Quality systems knowledge

SIM validation for medical devices

Mold/tool design understanding

Robotics/automation procurement

Statistical analysis & SPC

English communication

Educación

Bachelor’s degree in engineering or related field

Herramientas

Solid modeling CAD

PLC programming

CAD/3D modeling tools

Descripción del empleo

Vaupell Industrial in Constantine, MI is seeking a Program Manager to lead new product introduction activities for large-scale injection molding programs, coordinating design reviews, validation, and automation equipment. The role emphasizes FDA/industry quality standards and cross-functional teamwork to deliver on timelines and budgets.

The position requires a Bachelor's in engineering, 5+ years in program management, and strong knowledge of SIM validations, tool design, and DOE/STAT analysis.