CPE 1 LLC seeks a Product Development/Design Engineer to initiate, direct, and manage the design and development of new products and processes from concept to commercial manufacturing.
Requirements
- Design, plan, execution, and analysis involving design verification and design validation studies with physicians on devices that have been successfully brought to market
- Utilizing root cause analysis techniques including Fault Tree Analysis, Fishbone, or DMAIC to resolve technical issues, sample size/resource constraints, or other engineering hurdles
- Working on multiple products using Design control per FDA 21 CFR Part 820.30 and ISO 13485 across the full product development lifecycle from voice of customer through design input, design verification and validation, submission and clearance, process validation, to commercial release
- Neurovascular anatomy and physiology, and experience applying engineering principles to determine vascular product requirements
- Utilizing risk analysis tools such as Failure Mode and Effects Analyses and Risk Management Reports.
- Requires 2 years of experience with the following: Design, plan, execution, and analysis involving design verification and design validation studies with physicians on devices that have been successfully brought to market
- Requires 2 years of experience with the following: Utilizing root cause analysis techniques including Fault Tree Analysis, Fishbone, or DMAIC to resolve technical issues, sample size/resource constraints, or other engineering hurdles
Responsibilities
- Initiates, directs and manages the design, and development of new products and processes from concept to commercial manufacturing.
- Reviews, initiates or approves engineering drawings, layouts, changes orders and specifications.
- Plans process flow, evaluates process capability, modifies tooling, builds tooling, and designs tooling.
- Plans, schedules, conducts or coordinates detailed phases of the engineering work in a part o f a major project.
- Develops and /or reviews test procedures and plans prior to implementation, as well as conduct failure analysis and inspection on products, processes and materials.
- Evaluates, selects, and applies standard engineering techniques and procedures while using judgment when making minor adaptations and modifications.
- Devises new approaches to problems encountered.
Other
- Works closely with other departments to coordinate design engineering activities.
- Communicating with upper management, stakeholders, and external customers by leading a design review or similar exercise
- Providing a timeline and cost estimate of work toward a quote, engage with customer including status updates and resolving issues, and approach the customer regarding the quotation of out-of-scope work
- Must also have authority to work permanently in the U.S.
- Pursuant to section 656.10 of Title 20 of the Code of Federal Regulations (20 C.F.R. § 656.10), you are hereby notified that an Application for Permanent Employment Certification is being filed for the following position
