Principle Manager Engineer
Location | United States of America |
Job type: | Permanent |
Contact name: | Sam Murphy |
Contact email: | sam.murphy@rbwconsulting.com |
Contact phone: | 6175951613 |
Job ref: | 234567862345678 |
Published: | 3 months ago |
Expiry date: | 30 Aug 2024 23:59 |
Project Management:
Ideal candidates should have some project management attributes and experience, with a proven track record of growth and adaptability. This role is 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 that requires daily tactical responsibilities leading up to strategic decisions.
Essential Duties and Responsibilities:
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).
Develop and implement best practices for manufacturing commercial products.
Propose and implement vision, strategy, policies, processes, and procedures to aid and improve business performance.
Lead scale-up and commercialization efforts.
Conduct root cause investigations.
Lead life-cycle management efforts.
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.
Lead activities with third party contract research, development, and manufacturing organizations.
Ensure manufacturing strategies and processes meet business objectives and operational needs.
Evaluate challenges faced by the business and take actions to mitigate risks and develop opportunities.
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 to overall business strategy and annual budget process.
Provide project updates/reporting through program governance.
Provide leadership and support for inter-site best practices and phase-appropriate guidelines and policies.
Execute project strategy, priorities, and milestones ensuring visibility and accountability.
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, including project technical and budgetary information.
Qualification Requirements:
M.S. in Mechanical Engineering, Electrical Engineering, Material Sciences, or a related discipline with 6 to 9 years, 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 essential.
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.
Expert knowledge of mold tool design, optimization, qualification, and life-cycle management.
Expert knowledge of mechanical design with a preference for SolidWorks.
Expert knowledge of tools to conduct statistical and tolerance analysis.
Knowledge of regulations and standards including US 21 CFR Part 820, ISO 13485, ISO 14971, ISO 10993, EU MDR, etc.
Experience in developing orally inhaled and nasal drug products (OINDPs) is a plus.
Experience with Notified Bodies and CE marking is a plus.
Strong English language skills, including writing ability and oral communication.
Good judgment as well as cultural, social, and environmental awareness.