Lead Engineer, Mechanical (MedTech Catapult)

MedTech Catapult is a national initiative foraccelerating the development of high-value MedTech projects through an in-house product engineering unit. This productization unit is responsible for supporting the development of technologies through the medical device development cycle to produce full-fledged hardware product systems. The Lead Engineer will report to the Lead, Product Engineering.

Job Responsibilities

.Develop and engineer novel medical technology products from concept to pilot production.

.Production of high-quality engineering drawings and assembly specifications.

.Design, develop and test devices by building functional prototypes in a laboratory and test environment.

.Support development of intellectual property portfolio in device design and process technology know-how.

.Acquisition, set up, and, installation qualification of new equipment, including the creation of PM procedure as necessary.

.Prepare and support product development and quality planning (project schedule, resources, budgets, etc.).

.Develop feasibility and reliability testing plans, including the development and validation of accurate in-vitro and in-vivo models and methods.

.Focus on design for manufacturing by designing and developing pilot manufacturing equipment and procedures whilst assessing feasibility of processes and support manufacturing with validation plans and time studies.

.Manage and assist with verification and validation activities and documentation

.Collaborate with outside vendors on the design and sourcing of materials, components, and processing.

.Prepare documentation to support quality system for design functions (project plans, concept document, FMEA, design input, test results, drawings, etc.).

.Complete activities as project phase checklists.

.Review document changes in manufacturing for impact on design intent.

.Interact closely with engineers from other disciplines to achieve an optimized design within the stipulated project schedule.

.Provision of technical input to help identify and solve project risks affecting project schedules and plans.

.To support other activities for product engineering when required.

Requirements

.MSc in Mechanical engineering or related fields.

.At least 8-10 years of experience in design & development of life science instruments/medical devices (e.g. hardware, connected devices)

.Computer skills including MS office, SolidWorks or alternative CAD program

.Prototyping and materials knowledge for medical devices

.Experience with FDA CFR 820 and ISO 13485 regulations

.Experience in Electro-mechanical motion systems design, and fluidics and optics is a plus

.Experience in material selection and biocompatibility is a plus

.Experience in interventional medical device development is highly desirable

.Strength in problem-solving and decision-making

.High energy level, attention to detail and a sense of urgency

.Good collaboration skills, organized and detailed

.Demonstrate strong interpersonal skills and leadership skills