We are recruiting a Senior Mechanical Engineer, supporting the Chief Engineer with design and development of the SMI device and associated products. Key to the role is the need to follow Design Control (i.e. Product Realisation under ISO13485) and apply robust design tools (e.g. fault tree analysis, risk management). These are all required to efficiently achieve the right level of quality, safety and performance for a medical device. Industrialising/scaling the product through best practice design for manufacturing tools and techniques is also key. This role requires the ability to operate from first principle mechanical engineering tools and techniques – translating requirements into design intent analytically and empirically. For example, comfortably operating the tools and processes contained within the ICH Quality By Design, LEAN six sigma or systems engineering methodologies. The Mechanical engineer must be detailed, structured and process driven and have a disciplined approach to requirements & risk management – in other words “led by requirements, driven by data”.

In this role, you will be responsible for supporting the Chief Engineer with the design and development of invoX devices and necessary manufacturing processes in accordance with invoX requirements.

You will:

· Provide expertise in medical device design to ensure the successful design, development, and verification of invoX devices

· Establish and maintain design controls in accordance with invoX Standard Operating Procedures (SOP) and relevant regulatory guidelines

· Establish and maintain version control for all invoX devices that are currently in development and post-design freeze

· Lead the use of computer-aided design (CAD) and data management (PDM) software, aligned to relevant SOPs, including drawing standards, version & release control

· Managing and executing proof of concept activities through analytical (e.g. models, calculation) and verification through empirical testing, aligned with the appropriate level of samples/variants

· Applying appropriate analytical methods for project stage, with an understanding of required accuracy level

· Assessing (analytically and empirically) design intent of components and assemblies to the required physical manufacturing capability, quality & cost

· Analyse and interpret requirements/design data to evaluate and recommend “best fit/good enough” design solutions 

· Create/tailor design reviews/presentations/reports appropriately to third-party manufacturers, managers, and clients

· Author/review design input (e.g. requirements, DFMEAs)

· Align design output (e.g. specifications/CAD/BOMS/release notes) for invoX manufacturing partners, ensuring product is specified adequately and can be made to required quality and cost targets

· Ability to write reports and documentation to a high standard

· Provide technical advice and troubleshoot issues through the use of structured problem solving tools (e.g. 8D)

Essential Technical Skills 

· Master in Mechanical Engineering 

· Good understanding of medical device standards and essential requirements

· Hands on with a robust design process. Preferably ICH QbD related to CFR820 design controls

· Hands on risk management. Experienced with design product DFMEA tools.

· Hands on design for manufacture tools and techniques. Experienced with aligning the product DFMEA to process PFMEA tools.

· Hands on CAD/CAE, (Creo preferable), tolerance stack analysis & statistical tools (Jmp preferred)

· Materials expert. Medical grade plastics, springs and elastomers preferred

Essential Soft Skills

· Good understanding of the English language, both written and spoken

· Comfortable working in different cultures

· Flexible with a can-do and hands-on mentality.

· Self-starter with the ability to work autonomously.

· Excellent problem-solving skills.

· Good planning and organization skill

Desirable 

· Six sigma training

· Track record with patent filing and/or patent management

· Detailed understanding of respiratory standards and regulatory requirements

· Experience with complex respiratory devices

We get things done, we keep things simple and we are driven by the science. We are ambitious so we work hard to create an environment where we can take smart risks. We want to be innovative so encourage debate and collaboration to challenge the usual way of doing things. We love our celebrations and socialising, which make invoX a fun and diverse place to work. And most of all, everyone has the opportunity to make a difference.