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