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Engineer

Santa Clarita, CA
Permanent
Aditi Consulting
Payrate: $36.00 - $38.00/hr.

Summary:
The Device Engineer will play a critical role in the design, development, and lifecycle management of drug delivery devices, including prefilled syringes, with a focus on testing and analysis within a laboratory environment. This position requires strong experimental, analytical, and statistical skills to support technical operations and ensure the success of combination product portfolio.

Responsibilities:
  • Conducting hands-on experimental testing to support failure investigations and root cause analysis.
  • Developing, executing, and refining test procedures to evaluate device performance and functionality.
  • Analyzing test data and applying statistical methods to derive actionable insights and recommendations.
  • Supporting design changes by leading testing efforts to assess and validate proposed modifications.
  • Participating in the scale-up, global launch, and continuous improvement of drug delivery devices.
  • Collaborating with contract manufacturers and suppliers to ensure device quality and performance standards are met.
  • Maintaining robust design history files for mechanical and electro-mechanical delivery devices.
  • Enhancing and expanding delivery device platform as needed to meet evolving product and regulatory requirements.

Requirements:
  • Have strong laboratory testing experience, particularly with combination products and medical devices.
  • Possess a solid foundation in experimental methods and data analysis.
  • Be proficient in statistical tools and methodologies.
  • Demonstrate experience in failure analysis and implementing design solutions.
  • Have a proven ability to collaborate effectively within cross-functional teams.
  • Exhibit strong organizational skills and attention to detail, especially in maintaining design history files.
  • Show familiarity with regulatory and quality requirements for combination products and medical devices.
  • This role offers the opportunity to make a meaningful impact by leveraging technical expertise in a dynamic and innovative environment focused on advancing portfolio of drug delivery devices.

Must Have Skills:
  • Problem solving (engineering skillset)
  • Organization (self-starter and project level management)
  • Communication (experience communicating at different levels and to different groups)

Pay Transparency: The typical base pay for this role across the U.S. is: $36.00 - $38.00 /hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, denmatch, lifeion benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.

Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLCs use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.

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Job Type: Permanent

Job ID: 253409617