Product Design And Development Engineer (Must Have Design Control)

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

Location - San Diego, CA

Duration - 12+ Months Contract

Total Hours/week - 40.00

1st Shift

Client: Medical Device Company

Job Category: Engineering

Level Of Experience: Seniority Level

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

Description

We are seeking a highly motivated engineer for a unique opportunity to join a fast-paced global R&D team responsible for commercializing disposable infusion products such as IV sets. The successful candidate will be a detail-oriented self-starter with excellent interpersonal skills.

The individual will be responsible for working cross-functionally (internal/external stakeholders) to understand end-user needs, translating those into system requirements, developing robust design solutions, leading design verification and validation testing, and supporting design transfer to manufacturing and operations.

The individual is expected to proactively manage technical risks, drive testing, manage error budgets, and drive timely completion of projects.

Minimum Qualifications And Competencies

• BS - Mechanical/Chemical/Biomedical Engineering
• 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 engineering principles and strong experience in their application to solving technical problems.
• Background and experience in Design of Experiments and statistical methods of analysis.
• Prior experience of leading cross-functional team (internal/external) with members from R&D, marketing, sales, clinical, regulatory, operations etc.
• Strong analytical ability and demonstrated problem-solving skills.
• Hands-on experience with SolidWorks
• 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/Chemical/Biomedical Engineering
• 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
• Hands-on experience with Design for Six Sigma (DFSS) and Critical Parameter Management tools
• SAP