Device Mechanical Engineer

We represent a US-based, development-stage biopharmaceutical company headquartered in Weston, Florida. The mission of the company 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. They develop multiple inhaled approaches, including metered-dose inhalers, soft-mist inhalers, and dry powder inhalers.

Responsible for device engineering activities in the context of pharmaceutical research and development (R&D). The device engineer will be responsible for commercial manufacturing processes including semi-automated to automated and large-scale manufacturing and assembly operations. The device engineer 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. The device engineer will be responsible for developing, maintaining, and optimizing the supply chain with a keen eye for cost of goods (COGS) as applicable to raw material, manufacturing processes and overall supply chain. This position will be focused on orally inhaled and nasal drug products (OINDPs). The device engineer will interface with early device design teams and be responsible for independently providing direction, initiation, planning, coordination, implementation, execution, control, and completion of specific device project(s) ensuring consistency with organizational strategy, commitments, and goals. This is a hands-on position which requires daily tactical responsibilities leading up to strategic decisions.

Essential Duties and Responsibilities

• In support of the Product Development Teams, provide technical leadership in the device development area.
• Lead and execute manufacturing activities of devices with a focus on orally inhaled and nasal drug products (OINDPs).
• Responsible for developing and implementing 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.

Qualification Requirements

• A M.S, in Mechanical Engineering, Electrical Engineering, Material Sciences or related discipline with 6 to 9 years, B.S. with 12 to 16 years device development experience in pharmaceutical or related field.
• Experience with device development and manufacturing in the context of pharmaceutical R&D and product development is a must to have.
• 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 to have.
• 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.