Job Description
The Senior Technical Leader will be a key member of the product lifecycle engineering team responsible for supporting various product lines. This role involves providing technical guidance and support to cross-functional stakeholders, including product development, regulatory affairs, marketing, operations, and quality.
Key Responsibilities:
* Develop and execute product lifecycle engineering R&D projects which impact form/fit/function, business growth, cost reduction, and compliance.
* Lead engineering projects through change control processes.
* Communicate project updates and escalations as appropriate to line management and cross-functional stakeholders.
* Ensure compliance with local, international, and company quality and safety regulations, policies, and procedures.
* Collaborate with manufacturing plants to resolve issues and improve processes.
* Maintain robust design history files for current products and line extensions.
* Conduct competitive product analysis and device compatibility testing to inform business decisions.
* Design test equipment and create validated test procedures to demonstrate compliance with internal and external requirements.
Requirements:
A Bachelor's degree in Engineering or Science, preferably in Mechanical, Biomedical, or Chemical Engineering. Project Management qualification is an advantage. 10+ years' experience in medical device design or R&D, with a successful track record of delivering products to market and supporting them post-launch. Experience leading technical resources, implementing product changes through a structured product development process within a regulated framework, and technical problem-solving.
Desirable Skills:
* Medical product design, research, and development
* High volume manufacturing
* Polymer material science and injection molding processes
* Gauge Dimensioning and Tolerancing (GD&T)
* 3D CAD modeling
* Statistical analysis
* Project management