Job Description

TITTLE: PRODUCT DEVELOPMENT ENGINEER

DURATION: 12 MONTHS

LOCATION: SAN DIEGO, CA, 92121

JOB 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