Senior Mechanical Engineer - High-Volume Medical
Location : Oakland NJ US 07436
Job Type : Direct
Reference Code : 18850-BZ-MK1
Compensation : 120000.00 - 140000.00 USD/YEAR
Hours : Full Time
Required Years of Experience : 10
Required Education : BS Mechanical or Biomedical Engineering
Travel : No
Relocation : No
Job Industry : Engineering
Job Description :
- The Mechanical Engineer will work with R&D to develop new single use products.
- Responsible for design of single use plastic injection products for disease therapy.
- Lead the design efforts for single use products.
- Responsible for identifying, developing and delivering innovative and practical solutions in alignment with the product development road map.
- Lead the group, working with Marketing, in the next generation injection systems by understanding the customer needs and translating them into functional engineering solutions to design safe and effective single use disposable products for injection.
- Lead the efforts in creation of specifications, design, and test methods for injection products.
- Interface with manufacturing on an ongoing basis during the development stages to ensure manufacturability of the design solutions.
- Support the design for pen needles and syringes.
- 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 10 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 single use products with at least 5 years experience using Solidworks.
- Experience leading teams without authority cross functionally.
- Ability to lead new product development activities including conceptualization and design controls (design verification, validation, process validation etc.).
- Strong project management and experience working with outside design services.
- Experience managing budgets, timelines, design scope and manufacturing activates.
- Experience in developing vendors and partners.
- 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
- Experience in mechanical test systems such as Instron for measuring forces, speed, and pressure, highly desirable
- Travel- 10-15% domestic or international travel.
Contact: Monique Kleiman