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

bVZTVjNmWHhQWEwrSDByczlUOU85aU5TdHc9PQ==
  • 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

Medical Services of America

Nurse Practitioner Hospice Part-Time/PRN Job at Medical Services of America

 ...Medi Home Health & Hospice , a division of Medical Services of America Inc., currently seeks a Part-Time/PRN Family Nurse Practitioner for our Hospice location in Chesapeake, VA. The Nurse Practitioner must have exceptional clinical skills to perform comprehensive... 

Aquent

Visual Designer and Illustrator Job at Aquent

 ...Job Title: Visual Designer and Illustrator Client Location: Remote (PST hours) Starting: 06/02/2025 Salary/Pay Rate: $50-$55/hour on a W2 Firm, non-negotiable: Yes Hours: Full-time Duration: 3-month project Job Description: Our well-known... 

NEO Energy

Prevailing Wage and Apprenticeship Manager Job at NEO Energy

 ...Job Title: Prevailing Wage and Apprenticeship Manager (PWA) The Organisation: EPC within Power & Renewable Energy The Role: This role is essential for promoting operational efficiency and ensuring strict adherence to prevailing wage and apprenticeship requirements... 

Amazon Stores

Sr. Product Manager - Technical Job at Amazon Stores

 ...Manager - Tech to join the Buy with Prime (BwP) and Multi-Channel Fulfillment (MCF) team and be a product leader for Reporting & Analytics,...  ...partner closely with other product and technical teams across Amazon. If you enjoy dealing with high ambiguity and complexity, you... 

Farm Job Search

Organic Produce Farm Manager Job at Farm Job Search

 ...Organic Produce Farm Manager (6056) Location: Wisconsin JobNumber: 6056 Organic Produce Farm Manager position immediately available in southeast Wisconsin. This 20 acre farm and 5,000 square foot barn with heating & plumbing is a start-up business owned by a...