Looking for a new career opportunity?
Invenia Group has partnered with a fast-growing biopharma company seeking a highly motivated and experienced device engineering professional to provide strategic, hands-on technical leadership. This role is responsible for the end‑to‑end development, industrialization, and lifecycle management of drug–device and biologic–device combination products ensuring compliance with FDA (21 CFR Part 4, 21 CFR 820), EMA/MDR, ISO 13485, ISO 14971, IEC standards, and other global regulations.
The Director will lead cross-functional engineering activities that drive design, development, verification, validation, technology transfer, and ongoing commercial support for the Company’s device and combination product portfolio. This includes strong emphasis on design control, human factors engineering, risk management, supplier oversight, and manufacturing readiness from concept through post‑market support.
Role Responsibilities:
- Lead end to end development, manufacturing, and lifecycle management of combination products (e.g., prefilled syringes, autoinjectors, on body injectors) in full compliance with global regulatory requirements.
- Serve as the device subject matter expert across all development phases, including design development, verification, validation, risk management, human factors, and process validation.
- Define system architecture, assess design feasibility, lead material selection, guide prototyping, and ensure high quality technical documentation.
- Ensure seamless integration of drug product, device components, packaging, and delivery systems through effective collaboration with cross functional teams.
- Conduct and oversee design for manufacturing (DFM), reliability engineering, tolerance analysis, DOE, and design reviews.
- Develop and maintain design requirements, Design History Files (DHF), and Technical Files in alignment with Company ISO 13485 Quality Management System.
- Lead risk identification, analysis, evaluation, and mitigation using ISO 14971 methodologies (e.g., hazard analysis, design FMEA, process FMEA).
Education and Experience Required:
- Bachelor’s degree in Mechanical engineering, Biomedical Engineering, Chemical Engineering, or related scientific field
- Relevant industry experience in drug delivery device development and clinical/commercial manufacturing
- Demonstrated experience leading device development through commercialization.
- Must have experience with industry standard design and development tools (CAD, math modeling, tolerance analysis, and statistical software)
- Deep understanding of: FDA and EMA regulations for combination products
- Strong track record in managing external suppliers, CMOs/OEMs, and global manufacturing partners.
- Excellent communication, documentation, and leadership skills.
Sound interesting? Apply today to find out more.
