Engineer II R&D

3 weeks ago

Irvine, United States Planet Pharma Full time

R&D Engineer II

-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

-Basic understanding of Solidworks CAD system

-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

What will not work:

-Manufacturing or Quality engineer backgrounds

-Candidates with less than 3 years of experience

-Candidates without medical device experience

Please target candidates w/:

3 plus years of relevant work experience with a Bachelor's, Master's preferred

Schedule:

-Standard office hours, potential of overtime but not likely to exceed 5 hours.

Location:

-Irvine, CA campus (full time onsite)

Job Description: Applies knowledge of technical principles and systems/procedures to maintain and optimize CC legacy products.

Essential Job Functions: 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 25% Generate work instructions, test methods, engineering drawings/prototypes, etc. to establish/ characterize product and/or process specifications 25% Create/update portions of design control documents including requirement specs and risk documents 20% Assign R&D support tasks; gives instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work 15% Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers 10%

Required 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 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 environment and prevention of pollution under their span of influence/control

Level of Independence:

  • Works independently without close supervision
  • Compares and evaluates possible courses of action after considering various possibilities
  • Applies his or her knowledge in following procedures or in determining which procedures to follow or

determining whether specified standards are met

  • Considers the cause and effect of activities exhaustive, and which allow room for creativity and judgment
  • Direction tends to be high level and focused on end results with means of accomplishment left to incumbent

Education/Experience:

  • Bachelor's degree in engineering required. Master's degree preferred.
  • 3 + years experience required.

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