Product Design & Development Engineer (Must Have Design Control Exp)

Job Title - Product Design & Development Engineer (Must Have Design Control Exp)

Location - San Diego, CA

Duration – 12+ Months Contract

Total Hours/week - 40.00
1st Shift

Client: Medical Device Company

Job Category: Engineering

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1b’s

Description:
We are seeking a highly motivated engineer for a unique opportunity to join a fast-paced global R&D team responsible for value engineering and commercializing disposable infusion products. The successful candidate will be a detail-oriented self-starter with excellent interpersonal skills. The individual will be responsible for working cross-functionally to understand end-user needs, translating those into system requirements, developing robust design solutions, and supporting design transfer to manufacturing and operations. The individual is expected to proactively manage technical risks, drive feasibility testing, robustness testing, manage error budgets, cost models, and drive timely completion of projects. These projects can involve automation, mechanical design, mechanical testing, materials engineering and other types of mechanical engineering projects.
Minimum Qualifications and Competencies
• BS – Mechanical Engineering, Materials Engineering or Biomedical Engineering with emphasis on mechanical design and development
• Minimum 5 years of product design and development experience
• Working knowledge of design control processes and creating and maintaining design control documentation.
• Experienced in requirements engineering, hazards analysis, FMEA, verification and validation.
• Excellent knowledge of fundamental Mechanical Engineering principles and strong experience in their application to solving manufacturing and engineering problems.
• Prior experience of leading or working as part of a cross-functional team with members from marketing, sales, clinical, regulatory, operations etc.
• Strong analytical ability and demonstrated problem-solving skills.
• Excellent verbal and written communication skills
• Ability to work independently and to direct junior engineers and technicians.
• Ability to manage multiple projects of varying scopes at once.
Plus Factors
• MS – Mechanical Engineering, Materials Engineering or Biomedical Engineering with emphasis on mechanical design and development
• Prior experience in medical device industry, medical device design controls, ISO standards
• Prior experience in injection molding, plastic extrusion, DFM for high volume manufacturing, medical product sterilization
• Proficient in SolidWorks, Teamcenter
• Background and experience in Design of Experiments and statistical methods of analysis.
• Hands-on experience with Design for Six Sigma (DFSS) and Critical Parameter Management tools
• GD&T
• SAP