Product Development Lead
This is a challenging and rewarding role for an experienced product development professional. As a Product Development Lead, you will be responsible for managing the R&D/Product Development function within our organization.
* You will oversee all activities leading to clinical and commercial approval, ensuring that products are designed and developed to meet customer needs and regulatory requirements.
* You will recruit, manage, and develop senior and junior engineers, providing clear goals and objectives, and development feedback and opportunities.
* You will seek opportunities for continuous clinical and technical knowledge and expertise within the staff.
* You will support the development of departmental and program objectives, attached to a strategic plan, to ensure technology reaches its potential and departmental resources develop to facilitate this.
* You will manage health and safety within the test laboratory.
* You will support the development and maintenance of departmental budgets and resourcing plans.
* You will ensure interactions with colleagues/stakeholders fully reflect our company values.
* You will implement robust engineering practices and processes in product design and development to ensure reliability and quality.
* You will prepare regulatory submission-ready documentation for FDA and other regulatory bodies.
* You will support clinical activities and perform root cause investigations of identified product failure modes.
* You will develop and maintain our company's IP portfolio.
To succeed in this role, you will need a minimum of seven years of experience in a similar position in medical device product development, including project management and leadership roles. You should have a deep understanding of FDA and ISO 13485 requirements and experience in design, verification, and process validation processes.