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

Q28vWlZjdjgraW4xRHg0STNlV3QyYzh6M2c9PQ==
  • 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

Converge Heartland

Senior Pastor - Mandan Baptist Church Job at Converge Heartland

 ...Job Description Job Description Salary: $60,000-$70,000 Mandan Baptist Church (MBC) is looking for their next Senior Pastor to lead them in this next season of ministry. MBC is a family-integrated church where students and children comprise half of the congregation... 

Kaizen Technologies Inc

Hashicorp Vault Engineer Job at Kaizen Technologies Inc

 ...Role : Hashicorp Vault Engineer Location: Remote Hashicorp L3 Activities: # Architecture design and review # Performance tuning and optimization # Incident management and critical escalation # Code and configuration audit # Security compliance... 

Maximus

Data Science Analyst (Remote, NY) Job at Maximus

 ...are seeking a curious, analytical, and solutions-oriented Data Science Analyst to join our team and support strategic and operational initiatives...  ...upload speeds - Private and secure workspace #NYMC #LI-Remote EEO Statement Maximus is an equal opportunity employer... 

Maverick USA

Hedge Fund Accountant Job at Maverick USA

 ...seeking a motivated and detail-oriented individual to join our Hedge Fund Accounting team. This dynamic role offers the opportunity to...  ...with various departments across the firm, including portfolio management, legal, tax, technology, investor relations, fund administration... 

Novato Residence Inn by Marriott

Executive Housekeeper Job at Novato Residence Inn by Marriott

 ...Job Description Job Description SUMMARY Directs housekeeping program of hotel to ensure clean, orderly, and attractive conditions of hotel by performing the following duties personally or through subordinate supervisors. QUALIFICATIONS To perform this job...