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Mechanical Engineer

Location : Oakland NJ US 07436
Job Type : Direct
Reference Code : 19441-BZ1
Compensation : 110000.00 - 120000.00 USD/YEAR
Hours : Full Time
Required Years of Experience : 8
Required Education : BS Mechanical Engineering
Travel : No
Relocation : No
Job Industry : Engineering

Job Description :

  • Permanent position for a Mechanical Engineer to design and develop medical products suitable for high volume manufacturing (plastic injection molding and automated assembly/packing processes) from concept through commercialization utilizing a phase gate development process.

  • Write, implement and lead bench studies, tolerance stack up analysis, FMEAs, design verification, validation, vendor interactions, materials specifications and component specifications..

  • Responsible for identifying, developing and delivering innovative and practical solutions in alignment with the product development road map.

  • Support execution of technical and/or multi-functional project work in a design control regulated environment (ISO 13485).

  • Lead the efforts in creation of specifications, design, and test methods for injection molded products.

  • Interface with manufacturing on an ongoing basis during the development stages to ensure manufacturability of the design solutions.

  • Interface and influence manufacturing associates on a frequent basis to provide technical guidance on issues that affect DFMA, manufacturing capability and production rate.

  • Facilitate and coordinate clinical and formative studies to develop scope definition, design response correlations and design solutions.

Required Qualifications :

  • BS Mechanical or Biomedical Engineering

  • Minimum 8 years experience working with steel and plastic high volume injection molding, high-speed assembly process.

  • Experience with design of single use plastic and/or metal products with at least 5 years experience using Solidworks.

  • Experience with new product development activities including conceptualization and design controls (design verification, validation, process validation etc.).

  • Hands on- ability to work on test method development, fixture development, prototype assembly, preliminary concept generation testing/evaluation.

  • Experience in tolerance analysis of plastic components in molding and assembly.

  • Solid understanding of six sigma and statistical principles, root cause analysis, DOE etc.

  • Experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale up processes.

Contact: Bill Zukowsky

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