Device Mechanical Engineer

2 weeks ago


Fort Lauderdale, Florida, United States Jobot Full time
Amazing Pharmaceutical R&D and Product Development Opportunity

This is a unique chance to join a US-based, development-stage biopharmaceutical company headquartered in Weston, Florida. Our mission is to harness the power of inhaled drug delivery to improve patient access to important therapies and develop treatments for serious diseases where therapeutic options are significantly lacking.

Why Choose Us?
  • We offer a competitive salary range of $100,000 - $110,000 per year.
  • We provide a comprehensive benefits package, including 401(k) matching, dental insurance, health insurance, life insurance, paid time off, and vision insurance.
Job Details

As a Device Mechanical Engineer, you will be responsible for device engineering activities in the context of pharmaceutical research and development (R&D). You will lead and execute manufacturing activities of devices with a focus on orally inhaled and nasal drug products (OINDPs). You will also be responsible for developing and implementing best practices for manufacturing commercial products.

Key Responsibilities
  • Provide technical leadership in the device development area.
  • Lead and execute manufacturing activities of devices with a focus on OINDPs.
  • Develop and implement best practices for manufacturing commercial products.
  • Develop, propose, and implement vision, strategy, policies, processes, and procedures to aid and improve business performance.
  • Lead scale-up and commercialization efforts.
  • Lead root cause investigations.
  • Lead life-cycle management efforts.
  • Lead and execute technical analyses, including statistical analysis and tolerance analysis.
  • Document studies and author documents per US FDA, EMA, MHRA, and other global health authority requirements.
  • Interface and lead activities with third-party contract research, development, and manufacturing organizations.
  • Ensure that manufacturing strategies and processes are in place to meet business objectives and operational needs in terms of price, quality, and delivery targets.
Qualification Requirements
  • A M.S. in Mechanical Engineering, Electrical Engineering, Material Sciences, or a related discipline with 6 to 9 years of experience, or a B.S. with 12 to 16 years of device development experience in the pharmaceutical or related field.
  • Experience with device development and manufacturing in the context of pharmaceutical R&D and product development is a must.
  • Expert knowledge and experience with commercial-scale device manufacturing and assembly processes, including manual, semi-automated, and/or commercial-scale automated processes.
  • Expert knowledge of manufacturing processes, including injection molding and metal machining processes.
  • Knowledge of regulations and standards, including US 21 CFR Part 820, ISO 13485, ISO 14971, ISO 10993, EU MDR, etc.

We are looking for a highly skilled and experienced Device Mechanical Engineer to join our team. If you are passionate about pharmaceutical R&D and product development, we encourage you to apply for this exciting opportunity.



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