Device Engineer I/II in South San Francisco, CA at Integrated Resources, Inc

Date Posted: 11/30/2019

Job Snapshot

Job Description

Job Title: Device Engineer

Location: South San Francisco, CA

Duration: 12 Months

 

Job Description:

  • The Device Development department is searching for a dynamic Device Engineer to bring innovative drug delivery devices into clinical and commercial production to support company’s next-generation drug pipeline.
  • The candidate is expected to have technical expertise in the development of medical device and/or drug-device combination products, and be able to provide technical leadership to support engineering, scientific, and manufacturing activities within company.
  • The candidate will be assigned to teams developing leading-edge mechanical drug delivery devices while meeting the highest standards of quality and reliability.
  • The candidate will be responsible for providing design, development, and commercialization support to project teams that are developing combination drug delivery devices for parenteral pharmaceutical therapeutics at company.
  • The candidate, working with senior engineers and scientists, will work independently with general direction from project teams or functional management.
  • The work is reviewed upon completion.
  • Device engineering development primary Responsibility: Procure, design and develop lab-scale test equipment and test methods.
  • Design, fabricate, and procure fixtures & methods for device evaluation (primarily optical or tensile based methods).
  • Develop designs that provide the most cost effective, robust and reliable performance for medical devices.
  • Characterize device designs using appropriate tools such as DOEs, components of variance, house of quality, etc.
  • Characterize important material attributes (MAs) using appropriate tools such as tolerance analyses, empirical / mechanistic modeling with Monte Carlo simulation, FEA, etc.
  • Conduct Design Verification.
  • Review change requests associated with design of the product.
  • Proven experience in providing engineering technical input to a team composed of internal members along with external development partners and component suppliers is required.
  • Medical Device/Combination Product experience is necessary.
  • The ability to interact at a detailed technical level with process, human factors, and industrial engineers is also an essential skill.
  • In depth experience with design controls, test method development, and design verification methodologies is also required.

Skills:

  • Experience with GD&T.
  • Operating Machine Shop Equipment.
  • Lean/Six Sigma.
  • Technical skills in probabilistic design, tolerance analysis and design for manufacturing and assembly.
  • Experience working in a highly cross functional (e.g. Matrix) and collaborative environment.

 

Education and Experience:

  • Advanced degree, B.S., or M.S., in engineering or related discipline, with preference for Mechanical Engineering, or the equivalent.
  • 3 years of experience in industry or academia (including advanced studies) after receiving their Bachelor’s Degree.
  • Experience collaborating with internal and external suppliers and providing technical support to internal cross functional teams.
  • Prior experience with Design Controls.
  • Proven experience in test method validation and Gage R&R.
  • Drafting of device design verification protocols/reports and conducting design verification testing.
  • Expertise in CAD (Solidworks preferred), Rapid prototypting, material selection/biocompatibility, DFX, etc.
  • Experience statistical analysis and interpretation of data.
  • Familiarity with risk management tools (developments of pFMEAs, etc.).
  • Highly organized, detail oriented and strong communication skills including technical report reviewing and writing.