Biomedical Device Engineer (Biotech/Biopharma/Medical device) Job at Aditi Consulting, Thousand Oaks, CA

ZmpYOWJTblpRMU5XSVViKzY1bGRobWFLSXc9PQ==
  • Aditi Consulting
  • Thousand Oaks, CA

Job Description

Payrate: $35.00 - $42.00/hr.

Responsibilities:

  • Designing, developing, testing, and implementing medical devices, ensuring regulatory standards.
  • Engineers play a pivotal role in driving medical advancements by applying their technical expertise and creativity to develop innovative solutions
  • Experience with medical devices, combination products, drug delivery devices, syringes, vials
  • Additional equipment such as CT scanners, Instron tensile test machines and SEM may be used.
  • Knowledge of pharmaceutical/biotech processes
  • Familiarity with validation processes for Packaging areas
  • Familiarity with serialization process and networking
  • Familiarity with documentation in a highly regulated environment
  • Ability to operate specialized equipment, tools and computers as appropriate.
  • Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated
  • Lead evaluation of returned products, product reserve sample inspections, batch records and review of complaint histories and trends
  • Engineers are involved in every stage of the medical device development process, from concept design and prototyping to testing, manufacturing, and commercialization
  • Provide input to engineering for product improvements
  • Partner with device engineering to develop structured failure analysis processes and tools for current and future device platforms
  • Generate final reports in accordance with established procedures, which may include data collection and statistical analysis of the data
  • Help with investigations lab equipment setup, develop and provide equipment training to personnel, develop and validate test methods, and develop SOPs for equipment use.

Preferred Qualification:

  • Bachelor’s degree in science OR master’s degree in science
  • 2-3 years of experience in development or manufacturing environment, working with Medical Devices, ideally Class II and Class III
  • Demonstrated Six Sigma proficiency specifically for root cause analysis methodology
  • Experience with risk management per ISO 14971 (System Risk Analysis, User Risk Analysis, DFMEA/FMEA and other Risk Management tools)
  • Strong technical writing and interpersonal skills

Pay Transparency: The typical base pay for this role across the U.S. is: $35.00 - $42.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.

For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy ( policy).

Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human based decision making in employment decisions. By applying for this position, you agree to Aditi’s use of AI technology, including calls from an AI Voice Recruiter.

#AditiConsulting

Job Tags

Full time,

Similar Jobs

City of Glendale, AZ

Public Service Assistant Job at City of Glendale, AZ

 ...Hours per Week: 20 Description The Role: The Public Service Assistant performs a variety of technical and clerical...  ...assisting patrons in person and over the telephone. This is an entry-level classification. The ideal candidate for the role will have... 

Nidec Motor Corporation

Director, Government Relations Job at Nidec Motor Corporation

 ...products; we will continue our part in creating a better society.Job SummaryJob DescriptionThe Director of Government Relations will interact with local, state, and federal legislative bodies and government agencies to represent and protect the organization's business plans... 

ULTA SALON

Stylist Job at ULTA SALON

 ...responsible for engaging with guests, consulting with them on their hair care needs and recommending products and services. The Stylist...  .... Demonstrate high standards of customer service and salon image standards. Serve all guests, including walk-in guests,... 

Philadelphia Gas Works

Manager, Business Continuity Job at Philadelphia Gas Works

 ...leading natural gas providers, PGW prides itself on stability and continual growth. PGW is dedicated to becoming the Greenest Natural Gas...  ...the region. Become part of the PGW Team! Manager, Business Continuity This Manager I (M1) level position is... 

Mainz Brady Group

Robotics Engineer Job at Mainz Brady Group

 ...hear from you. Requirements: ~3+ years of experience in robotics and process automation development. ~ Proven experience with...  ..., and Texas. We specialize in Information Technology and Engineering placements on a Contract, Contract-to-hire, and Direct Hire basis...