R&D Manager Job Description
Our client, a high-potential medical device start-up, is seeking an R&D Manager to join their team. The R&D Manager will report to the VP of R&D and be responsible for managing people and departmental activities within the R&D/Product Development functions.
Key Responsibilities:
* Recruit, manage, and develop senior and R&D engineers, providing them with clear goals and objectives, development feedback, and opportunities.
* Seek opportunities for building continuous clinical and technical knowledge and expertise within the staff.
* 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.
* Manage health and safety in the test laboratory.
* Support the development and maintenance of departmental budgets and resourcing plans.
* Ensure interactions with colleagues/stakeholders reflect the company values.
* Implement robust engineering practices and processes in product design and development to ensure final products are reliable and of the utmost quality.
* Align test plans and testing with regulatory requirements.
* Prepare regulatory submission-ready documentation for the FDA and other regulatory bodies.
* Support clinical activities, including limited clinical case support, and perform root cause investigations of identified product failure modes.
* Support the ongoing development of the company's IP portfolio.
* Stay up-to-date with technological changes within the therapeutic domain, ensuring the company and staff are aware of the state of the art in areas such as polymer materials, nitinol, tissue engineering, test methods, imaging technologies, etc.
* Stay informed about changing regulatory standards and how they can impact planned technical work within R&D and Product Development Activities.
* May manage the development of new products that meet patient, customer, and business needs.
* May serve as project lead on one or more projects, developing plans and goals for the project which meet overall company goals.
Requirements:
* Minimum of a Bachelor's degree in Mechanical or Biomedical Engineering, or a related field.
* Minimum of seven years in a similar role in medical device product development, with a minimum of three years in project management/leadership roles of technical projects across R&D and Manufacturing as a senior or principal R&D engineer.
* The projects should incorporate new product development (preferably in Class III cardiovascular devices).
* Good leadership and project management skills with the ability and willingness to effectively build and manage a small team.
* Demonstrated experience in people mentoring and development.
* Deep and current understanding of FDA and ISO 13485 requirements, with the ability to interpret these requirements and implement them into new product development.
* Experience in design, verification, and process validation processes.
* Broad knowledge of materials and manufacturing processes applicable to the medical device industry is desirable.
* Experience working with subcontract manufacturers/suppliers/test facilities, including integration of their activities into product development activities.
* Previous experience in planning and preparing regulatory submissions to agencies, competent authorities, and/or notified bodies.
* Excellent communication, organizational, and time management skills.
* Good problem-solving mindset.
* Strong verbal and written communication skills.
* Ability to thrive in a start-up environment and effectiveness in delivering results in low-structured environments.
* Ability to communicate within a team/company structure and achieve project and company objectives.