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

YVpTZTdKZWw0enNyRjB5MXFPY2ZqNkFBNmc9PQ==
  • 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

BD (Becton, Dickinson and Company)

Sr. Training & Education Consultant Job at BD (Becton, Dickinson and Company)

 ...Summary**Within SDS Readiness and Education, the Training and Education...  .... Training and Education Consultants utilize their experience, knowledge...  ...adoption and utilization.+ Work effectively across diverse...  ...to work independently from a home office and maintain a... 

Advocate Aurora Health

Nurse Practitioner or Physician Assistant- Inpatient Neuroendovascular & Stroke Team- St Lukes Job at Advocate Aurora Health

 ...established standards and guidelines. ~Provides clinical direction to nursing staff regarding the continued care of patients. Follows...  ...Education Required: ~Master's Degree in Nursing. Experience Required: ~No experience required. Knowledge, Skills &... 

(add)ventures

Senior Copywriter, Healthcare - Part-time Contract Job at (add)ventures

 ...Senior Copywriter with writing chops in the healthcare space to work on our Content team. If youre a problem-solving storyteller with...  ...strategic vision and creative ideas, youll find yourself right at home on our team of wordsmiths who inform and inspire through creative... 

BWX Technologies

Analyst, Investor Relations Job at BWX Technologies

 ...continents. Our joint ventures provide environmental restoration and operations management at a dozen U.S. Department of Energy and NASA facilities. BWXTs technology is driving advances in medical radioisotope production in North America and microreactors for various... 

MARIJUANA COMPANY

Inventory Specialist Job at MARIJUANA COMPANY

We are a vertically integrated medical marijuana business with two dispensaries, processing, and cultivation facilities. We're looking for someone who is reliable, can work under pressure, and someone with highly proficient skills for managing time, prioritizing, staying...