About the role
AI summarisedAs part of the MedTech Catapult national initiative, this role leads product engineering efforts within an in-house unit dedicated to accelerating high-value MedTech projects. You will guide the development of technologies through the medical device lifecycle to produce full-fledged hardware product systems, reporting to the Lead, Product Engineering.
ResearchOnsiteMedTech Catapult
Key Responsibilities
- Lead design teams through full product development, from conceptualization to early product production.
- Oversee the systems engineering plan and collaborate with cross-functional teams on hardware, connected devices, and related technologies for multiple parallel projects.
- Guide the definition of system requirements, architecture, and interfaces to meet product needs, risk analysis, and industry standards for novel MedTech systems.
- Manage feasibility studies for each phase of conceptual design and product architecture, from inception to completion.
- Ensure products meet user expectations, technical requirements, budget, and quality specifications through analytical studies, verification, and validation.
- Ensure compliance with appropriate Quality Management Systems (QMS) and regulatory specifications, including document control and stakeholder communication.
- Provide technical guidance, mentorship, and direction to engineers and stakeholders throughout the product development lifecycle.
Requirements
- Masters in System Engineering, Electromechanical, or a related engineering discipline.
- >15 years of experience in medical devices/life science instruments (hardware, connected devices) managing product design and development.
- Hands-on experience in system architecture and integration of mechatronic and software systems.
- Proven experience in Systems Engineering related to stakeholder needs definition, use case workflows, requirements decomposition, functional architecture, and system design.
- Experience generating technical documentation including product requirements, specifications, engineering reports, test plans/procedures, and validation reports.
- Outstanding written and verbal communication and presentation skills for all organizational levels.
- Strong track record of technical leadership within cross-functional teams.
- Ability to lead and coordinate with remote development teams.
- Proven ability to manage multiple projects simultaneously.