R&D Engineer

2 weeks ago

Santa Ana, United States TalentBurst Full time
Position: R&D Engineer II, Req#: 7374-1
Location: Santa Ana, CA (100% onsite)
Duration: 12+ Months Contract

Job Description:

Applies knowledge of technical principles and the client's systems/procedures to maintain and optimize CC legacy products.

Education and Experience:
  • Bachelor's degree in engineering required.
  • 3+ years of experience required.
  • 3 plus years of relevant work experience with a Bachelor's, Master's preferred
  • Bachelor's in mechanical or biomedical engineering preferred
Must haves for this position:
  • Prior experience as a sustaining engineer (R&D) in a medically regulated industry (Class II or III highly preferred)
  • Design verification and validation experience in the medical device industry
  • Exposure to failure mode analysis.
  • PPK, MLTL, or any base-level knowledge of statistical tools or analysis (Minitab use).
  • Test method validation
  • Design verification (plans & protocols), reporting, and testing
  • Data failure analysis on the design verification testing
Additional Skills:
  • Good computer skills in usage of MS Office Suite; CAD experience preferred
  • Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
  • Basic understanding of statistical techniques
  • Previous experience working with lab/industrial equipment required (if applicable)
  • Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
  • Solid problem-solving, organizational, analytical and critical thinking skills
  • Solid understanding of processes and equipment used in assigned work
  • Knowledge of and adherence to the client's Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast-paced environment
  • Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
  • Ability to build productive internal/external working relationships
  • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control
Roles and Responsibilities:
  • Test, and/or improve products by developing moderately complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles
  • Generate work instructions, test methods, engineering drawings/prototypes, etc. to establish/ characterize product and/or process specifications
  • Create/update portions of design control documents including requirement specs and risk documents
  • Assign R&D support tasks; gives instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
  • Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers
  • Other duties assigned by Leadership


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