Device Senior Mechanical Engineer

To help continue our growth and success, we are looking for a Senior Mechanical Engineer to join our dedicated team on its journey to achieve invoX's vision to become a globally recognized, fully integrated pharmaceutical company, with an advancing pipeline of innovative products addressing unmet healthcare needs, directly improving patients' lives.

This key role involves working as a technical lead with the device Chief Engineer to manage the progression of the device research, design & development - from concept development to design transfer. Precision mechanical engineering is the core technical skill for this role. Specific focus on a requirements led, data driven approach with design specialities in precision plastic parts, microfluidics, springs and elastomers and the ability to quantify quality and reliability "design space" of these parts.

This role will report functionally to the Head of Device Development and technically to the Chief Engineer.

Main Accountabilities and Responsibilities

Accountabilities and Responsibilities include, but are not limited to:

• Working as the technical lead with the device Chief Engineer to progress device concepts from research, design & development to industrialisation
• Delivery of the required level of quality and reliability design definition ("design input") – including requirements, risk management, design concept function specifications, characterisation, models, design space & capability assessment studies
• Owning key device design components & mechanisms, evaluating and establishing the function to design intent through tools such as modelling and rapid prototyping
• Co-ordinating and driving device/technical design reviews
• Working with affiliated technologies and functions to enhance the product device quality is achieved "design for…." E.g. injection moulding, manufacturing assembly and test
• Working closely with the industrialisation teams "design for manufacture" to establish achievable product "design output" capability
• Manage (identify and mitigate) device technical risks through tools such as fault tree analysis ad DFMEA
• Maintain articulate, timely and effective reports and communications with internal and external stakeholders

Experience/Qualifications

• Master in Mechanical Engineering or related engineering/science discipline.
• Experienced in managing/owning the design and development of precision and/or safety critical product; ideally solid experience within inhalation or parenteral device development industries and/or drug+device "combination" products
• An advantage:

o Experience leading/owning design control process improvements in a medical device R&D environment

o Pharmaceutical drug development expertise with a special focus on respiratory

o Design for six sigma design tool experience

o Chartered Engineer

Key Technical Skills
The following key technical skills are required (M)andatory or (A)dvantage for the role;

• (M) Mechanical engineering from first principles; ability to design, develop and ascertain design concept quality and reliability levels
• (M) Design experience with injection moulding & precision plastic parts
• (M) Mechanical engineering foundation tools e.g. fault tree analysis, tolerance stack analysis
• (M) CAD proficient (e.g. Pro-E, Solidworks); high proficiency in managing and maintaining drawing standards, geometric dimensioning and tolerancing
• (M) Hands on statistical analysis e.g. JMP, Minitab
• (M) Hands on MS Office tools (e.g. Word, MS Project, Excel)
• (A) Design experience with micofluidics, springs, elastomers
• (A) Mechanical engineering advanced tools; finite element analysis (FEA), computational fluid dynamics (CFD)
• (A) Change control tools; management and release of BOMs and specifications
• (A) PDM proficient (e.g. Windchill)
• (A) Hands-on, problem-solver. Proficient with root cause tools e.g. 8D and DMAICs/DMADVs

Key Interpersonal & Leadership Skills
The following key interpersonal and leadership skills and capabilities are considered essential to the role:

• Requirements led, data driven mindset
• Analytical, disciplined and detailed
• Pro-active, self-starter, takes the initiative
• Leadership skills; confident & considerate
• Able to work to objectives, prioritize & manage workload
• Excellent communication and networking skills.
• Strong numeracy and literacy
• Fluent in English, spoken and written – Dutch speaking an advantage

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.

invoX Pharma was incorporated in March 2021 and is a wholly owned subsidiary of Sino Biopharm, a Hong Kong listed, global top 40 pharmaceutical company with more than 24,000 employees. UK-based invoX is an expanding biopharmaceutical company focusing on R&D, Clinical Development and Business Development activities in the UK, EU and US, with a core focus on oncology and respiratory therapeutics.

Our core team is made up of a multicultural international group of highly experienced individuals with life sciences and technology-centred backgrounds, all with a mutual passion and ambition for creating something different.

Mission: invoX's mission by 2026 is to be a globally recognised, fully integrated pharmaceutical company with an advancing pipeline of innovative products addressing unmet healthcare needs.

Purpose:We aspire to improve people's lives by creating access to innovative medicine.

Vision: To be a leading global pharmaceutical company through delivering innovative therapies for patients.