Essential Functions:
- Technical owner of work streams within the development of parenteral and inhalation drug delivery systems from concept design to commercialization as required by the project plan
- Manage teams of internal, external, and contract resources that design, deliver, validate and maintain manufacturing systems for a drug delivery medical device. Develop and maintain all aspects of Design History File working with internal and external vendors
- Owner of authoring and maintaining Design Control documents per various regulatory standards like US-FDA 21-CFR Parts 210, 211 & 820, EU-MDR and relevant ISO standards
- Complete the risk management activities to meet project timescales, device performance and quality requirements
- Ensure that all project inputs and outputs are thoroughly documented, providing a robust and detailed design history file for device developments, acting as a role model for other members of staff in terms of the quality of documentation produced
- Develop methods for validation, product performance testing, environmental and shelf-life testing. Review new designs, enhancements, and programs with product developers and the formulation team to support a robust drug-device combination product
- Mentor design engineers in development process
- Manage budgets, project schedules, and report and resolve project issues. Lead cross-functional partnerships with department heads in R&D, operations, quality assurance, contract manufacturers, and other stakeholders to define project scope, estimates, and seek organizational alignment
- Deliver excellent customer service to stakeholders and internal customers, work with Quality Engineers and Regulatory Affairs to ensure device related documentation is maintained per relevant standards. Experience in developing URS for submitting to Assembly Automation vendors.
Skills:
- Strong skills in GD&T, DFM/A & DHF documentation – Advanced
- Risk Assessment methodologies like Fault Tree Analysis, FMEA, Hazard Analysis etc. – Advanced
- Proficient with Solidworks design software – Advanced
- Strong skills in developing V&V methods and processes for Functional Test Systems – Advanced
- Strong background in design, development and validation of injection moulded components – Advanced
- Experienced in the development of intricate but robust mechanisms – Advanced
- Experienced in risk assessment and risk management – Advanced
- Highly detail oriented in design, debug, and documentation work. – Intermediate
- Ability to plan work and accomplish objectives with minimum direction. Strong written and verbal English language communication skills. – Intermediate
- Strong skills in creating and making technical presentations to small and large audiences – Intermediate
- Strong communication and organizational skills – Intermediate
- High attention to detail, personal initiative, and follow-through – Intermediate
Specialized Knowledge:
- 5-8 years of previous Drug Delivery Device (Auto Injector / Pen injector / inhaler) design or quality experience preferred.
Education:
- Bachelors Degree (BE in Mechanical Engineering): Engineering Design, Medical device design or related - Required
- Master Degree (MS/MA in Mechanical Engineering): Engineering Design, Medical device design or related - Preferred
Experience:
- 14-16 years’ experience is required.
- 5-7 years of managerial experience is required.
- 10 years or more medical industry experience is required.
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
