Medical Device Design Engineer
Location : Monroe NY US 10950
Job Type : Direct
Reference Code : 19258-BZ1
Compensation : 90000.00 - 110000.00 USD/YEAR
Hours : Full Time
Required Years of Experience : 3
Required Education : BS Mechanical or Biomedical Engineering
Travel : No
Relocation : No
Job Industry : Medical Devices
Job Description :
- Permanent position for a Medical Device Design Engineer for design of sterile, high quality, disposable medical devices.
- Plan, implement, monitor and deliver designated tasks and deliverables to achieve project driven objectives for New Product Development.
- Provide technical support to regulatory submissions and product transfers.
- Support current products in terms of quality, manufacturing, supply continuity and cost improvement.
- Take product from concept through to production with a practical understanding of manufacturing and solid engineering fundamentals.
- Provide innovative solutions concerning product design and development, and DFM.
- Utilize pilot production methods and materials together with DOE and FMEA for proof of concept.
- Using SolidWorks, develop innovative designs, assign realistic specifications, account for assembly tolerances within the device and work within vendor process capabilities.
- Work seamlessly within multi-user SolidWorks environment for file sharing and revision control.
- Lead activities related to test and evaluation of prototypes and finished medical devices.
- Coordinate internal and external design program resources as well as vendors.
- Ensure compliance with quality policies, procedures and practices as well as with all local, state, federal, international and company safety regulations, policies and procedures.
Required Qualifications :
- BS Mechanical or Biomedical Engineering
- Minimum 3 years experience with disposable medical device design.
- Project management experience.
- Experience with SolidWorks.
- Expertise in Design for Assembly (DFA) and Design for Manufacturability (DFM).
- Experience in plastic materials and injection molding techniques.
- Knowledge of medical device sterilization methods and its effect on materials and packaging methods.
- Demonstrated experience or knowledge with all phases of the Design Control and Validation processes in the context of FDA and ISO 13485 regulations and understanding of disciplined product development processes, regulatory and quality requirements for medical products.
- A clear understanding of manufacturing process validation including FAI/FAT, development and IQ/OQ/PQ, with experience in the implementation of these activities.
Contact: Bill Zukowsky