Device Mechanical Engineer

2 days ago

Fort Lauderdale, Florida, United States Jobot Full time
About the Opportunity

This is an exciting opportunity to join a US-based, development-stage biopharmaceutical company as a Device Mechanical Engineer. The company is headquartered in Weston, Florida, and is dedicated to harnessing 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.

Job Summary

The Device Mechanical Engineer will be responsible for device engineering activities in the context of pharmaceutical research and development (R&D). This includes commercial manufacturing processes, from semi-automated to automated and large-scale manufacturing and assembly operations. The successful candidate will utilize industry-standard and novel equipment, processes, and methodologies to transform raw materials, components, and parts into finished goods to the required standards of safety, quality, cost, and delivery across supply chain channels.

Key Responsibilities
  • Provide technical leadership in the device development area, supporting the Product Development Teams.
  • Lead and execute manufacturing activities of devices, with a focus on orally inhaled and nasal drug products (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, and that enable the organization to function and compete effectively in the market.
  • Proactively evaluate the challenges faced by the business and take actions to mitigate risks and develop opportunities.
  • Contribute towards and maintain device design history files (DHF).
  • Document standard operating procedures (SOPs) for design controls and manufacturing in the context of pharmaceutical drug-device combination products.
  • Contribute towards overall business strategy and annual budget process.
  • Provide project updates/reporting through program governance.
  • Provide leadership and support for inter-site best practices (technology transfer, process validation, etc.) and phase-appropriate guidelines and policies.
  • Execute project strategy, priorities, and milestones, ensuring visibility and accountability.
  • Proactively lead with integrity and engage cross-functional project teams and stakeholders.
  • Support organizational/departmental initiatives.
  • Prepare and conduct presentations to all levels of the organization, which may include project technical and budgetary information.
Requirements
  • A M.S. in Mechanical Engineering, Electrical Engineering, Material Sciences, or related discipline with 6 to 9 years of experience, or 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.
  • Must possess expert knowledge and experience with commercial-scale device manufacturing and assembly processes, including manual, semi-automated, and/or commercial-scale automated processes.
  • Must possess expert knowledge of manufacturing processes, including injection molding and metal machining processes.
  • Must possess knowledge of regulations and standards, including US 21 CFR Part 820, ISO 13485, ISO 14971, ISO 10993, EU MDR, etc.
  • Experience with device assembly processes, including manual, semi-automated, and/or commercial-scale automated processes, is a plus.
  • Experience in development of orally inhaled and nasal drug products (OINDPs) is a plus.
  • Experience in mold tool design, optimization, and qualification is a plus.
  • Experience with Notified Bodies and CE marking is a plus.
  • Strong English language skills, including writing ability and oral communication.
  • Demonstrates good judgment as well as cultural, social, and environmental awareness.

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