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

aTRKMGU0T0RWbHhVdnNZMHVzWXpoYzRrVVE9PQ==
  • 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

Smart4Chemicals

Process Engineer Job at Smart4Chemicals

 ...Smart4Chemicals are looking to recruit an Operations Engineer to support the operation of leading polymer and chemical manufacturer based...  ...cost-saving initiatives. You will also be responsible for process troubleshooting, production scheduling, and ensuring safe and efficient... 

ODORZX INC.

Hiring: Drivers, In-Fleet Agents & Service Agents $13 to $15- (MCO) Job at ODORZX INC.

 ...currently seeking Drivers, In-Fleet Agents, and Service Agents to join our team at ODORZX INC. located at Orlando Airport . In this role, you will be responsible for...  ...attention to detail and a high level of customer service . Responsibilities: Transport... 

CLS Health

Credentialing Specialist Job at CLS Health

 ...multispecialty care. We're a dynamic team on a mission to provide better healthcare options for Houstonians! Job Summary: The Credentialing Specialist plays a vital role in the healthcare industry by ensuring that all healthcare providers within an organization meet... 

Law

Associate Job at Law

A reputable law firm in New Jersey, specializing in insurance law, is seeking an Insurance Defense Associate. Join a dynamic team and work on high-profile insurance disputes in a collaborative, growth-focused environment. Qualifications: ~ J.D. and active New Jersey...

Insight Global

Customer Service Representative Job at Insight Global

 ...one or more of our core business verticals based on the needs of our business. As an...  ...and a passion for high-quality customer service. How youll make an impact Process...  ..., troubleshooting application issues, answering questions regarding loan repayments, and...