Senior Device Engineer, Pharmaceutical R&D

Transpire BIO Inc.•Weston, FL

About The Position

The Senior Device Engineer is responsible for device engineering activities in the context of pharmaceutical research and development (R&D). The device mechanical engineer will be responsible for early to late-stage device development activities and commercialization of drug-device combination products. The Device engineer will be responsible for design, prototyping, technical analysis, and testing of orally inhaled and nasal drug products (OINDPs). Provide device engineering leadership in the direction, initiation, planning, coordination, implementation, execution, control, and completion of specific device project(s) ensuring consistency with organizational strategy, commitments, and goals. The device engineer will need to ensure that the device designs meet user needs, regulatory and quality requirements, and consider manufacturability. This is a hands-on position which requires daily tactical responsibilities leading up to strategic decisions.

Requirements

A M.S, in Mechanical Engineering, Electrical Engineering, Material Sciences or related discipline with 7 to 10 years, B.S. with 10 to 14 years device development experience in pharmaceutical or related field.
Experience with device development in the context of pharmaceutical R&D and product development is a must to have.
Must possess expert knowledge of mechanical design with preference for SolidWorks.
Must possess expert knowledge of tools to conduct statistical and tolerance analysis.
Must possess 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.
Strong English language skills including writing ability and oral communication.
Demonstrates good judgment as well as cultural, social, and environmental awareness.

Nice To Haves

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.
Experience in a regulated laboratory (pharma, biotech, medical device, mechanical, or environmental)
Knowledge of GMP, GLP, or ISO standards

Responsibilities

In support of the Product Development Teams, provide technical leadership in the device development area.
Execute design and development of orally inhaled and nasal drug products (OINDPs) following design controls.
Lead and execute analysis for device and product characterization, design feasibility, and design verification.
Lead and execute technical analyses including statistical analysis and tolerance analysis.
Lead root cause investigations.
Support scale-up and commercialization efforts.
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.
Contribute towards and maintain device design history files (DHF).
Document standard operating procedures (SOPs) for design controls in the context of pharmaceutical drug-device combination products.
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.