Development Engineer

IQ Endoscopes Limited; Chepstow; Hybrid; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Hybrid working

Annual leave 25+ days

Bank holidays

Pension scheme

EV car salary sacrifice

Refer a friend bonus

Dependent leave

Disconnect days

Job summary

IQ Endoscopes Limited is seeking an ambitious engineer to research and implement technologies for single-use endoscopes and related equipment. You will create design and manufacturing improvements, resolve challenges, and support regulatory submissions.

The role involves developing full design packages, DHFs and risk management files, with occasional travel to manufacturing partners. A strong background in medical devices and design control is essential.

Qualifications

• Degree in mechanical engineering, product design, process engineering or related discipline.
• 3+ years’ experience in product development or sustaining engineering within medtech or a highly regulated industry.
• Strong competency in engineering analysis methodologies, design control and traceability, and change control.
• Strong competency in PFMEA-led process control.
• Proficiency in CAD and Product Data Management (SolidWorks).
• Strong interest and understanding of the medical device field.

Responsibilities

• Develop and test new technologies, design solutions and process solutions for single-use endoscopes and related equipment.
• Design mechanical and electrical medical devices with design for manufacture in mind.
• Perform engineering analysis on relevant designs.
• Produce design packages and drawings for transfer to manufacture.
• Collaborate with CMO partners to develop and qualify manufacturing processes.
• Visit CMO facilities to support investigations, trials and improvements.
• Lead technical investigations into reported issues to identify root causes.
• Implement design changes and manage verification/validation activities.
• Support engineering change activities, including change specification, impact assessment, verification and transfer to production.
• Plan and conduct tests and design test jigs/methodologies to support verification/validation.
• Overcome challenges to enable fast-paced progress.

Skills

Engineering analysis

Change control

PFMEA

CAD

Product Data Management

Medical devices interest

Education

Mechanical engineering / related degree

Tools

SolidWorks

Job description

We have a product with the capacity to genuinely change lives for the better and bring huge benefits to the medical device industry and industry professionals, and we want our new colleagues to feel as passionate about our mission as we are. At IQ Endoscopes, culture is incredibly important to us, and we recruit colleagues who fit that culture. This isn’t just a job to us, it’s a passion. We want you to be a part of our vision and to find your purpose within our organisation.

PURPOSE: To create pioneering endoscopy technologies for the early diagnosis of diseases, helping people live longer & better

VISION: A world where everyone has easy access to safe, sterile endoscopy

MISSION: To deliver high quality GI endoscopy solutions, usable in any clinical setting

STRATEGY: To establish the single use GI endoscopy market this year with a product range that is clinically, commercially andsustainably credible and scalable

Our values

We work together to achieve shared goals through our values…

PASSIONATE: We show our pride and enthusiasm.

INNOVATIVE: We challenge, question and push past the status quo.

EMPOWERED: We support our people to explore their own potential.

INCLUSIVE: We understand the value of an alternative perspective.

TRANSPARENT: We are open to our people, sharing information and knowledge.

The opportunity

IQ Endoscopes is seeking an ambitious and motivated individual with a strong interest and experience in medical device development to research implementation of technologies and design solutions into our range of single use endoscopes and associated equipment. You will Implement design and manufacturing improvements, resolve technical challenges and support the ongoing development and optimisation of our product and manufacturing processes. As well as generating full design packages, design history and risk management files to support design transfer and regulatory submissions. This role is vital role in the structure of our team adding huge value to an early stage and growing MedTech organisation.

Some travel to manufacturing partners may be required.

Your responsibilities

• Develop and test new technologies, design solutions and process solutions for our range of single-use endoscopes and associated equipment.
• Design mechanical and electrical medical devices, including design for manufacture and assembly/disassembly.
• Perform engineering analysis on relevant designs.
• Produce design packages, including part and assembly models and drawings, that can be transferred to manufacture.
• Work closely with CMO partners to support development and qualification of manufacturing processes in parallel with design evolution, participating in review and control of DMR artefacts.
• Visit CMO facilities as required to support technical investigations, manufacturing trials and process improvements.
• Lead technical investigations into reported issues (e.g. from customers and manufacturing) to identify root causes.
• Lead the technical implementation of design changes.
• Support engineering change activities, including specification of change, design and manufacturing impact assessment, verification of change and transfer of change to production.
• Support verification and validation activities by planning, performing and documenting tests and designing test jigs and methodologies, as appropriate.
• Overcome challenges and solve problems to enable fast-paced progress.

What you must have

• A degree in mechanical engineering, product design, process engineering or related discipline
• No less than 3 years’ experience in product development or sustaining engineering within medtech or a highly regulated industry
• Strong competency in engineering analysis methodologies, design control and traceability, and change control
• Strong competency in PFMEA-led process control
• Proficiency in CAD and Product Data Management (this role will use Solidworks)
• A strong interest and understanding of the medical device field

How you like to work

• Detail-oriented, ensuring accuracy, completeness and traceability of engineering work and documentation
• Well organised, able to manage their own time effectively and track multiple tasks at various stages of completion
• Sets high standards for themselves, and maintains a high standard of output in a fast paced environment
• Builds positive collaborations with colleagues, suppliers and customers; able to travel to supplier/customer sites
• Growth mindset; willing to pick up new skills and make informed decisions based on available evidence and expertise
• Motivated by working in a small team and willing to work outside of your specialist area to support the wider team and business

What we will give you

Alongside opportunity for personal development and growth within an early stage commercial MedTech organisation you will be entitled to:

• Competitive salary to fit this level of position
• Hybrid working Tuesday and Wednesday onsite, Thursday role dependent
• 25 days annual leave plus bank holidays
• 2 additional days paid dependents leave & paid compassionate leave
• 2 additional paid ‘Disconnect Days’ following 6 month milestone
• 2 additional days of annual leave following 2 and 3 year milestones
• Enhanced pension 5% paid by employer & 3% employee with salary sacrifice scheme available
• EV Car salary sacrifice scheme
• Refer a friend bonus

Health Shield: an employee health & wellbeing platform encompassing:

• 24/7 EAP service
• A cashback service for both essential and non-essential health and well-being treatments
• GP Anytime: 24/7 access to a phone or chat based GP
• Face to face counselling: referral where required through EAP service
• Access to online health screening, physiotherapy & skin detection

Equity, Diversity and Inclusion at IQ Endoscopes

At IQ Endoscopes we work hard, but we give ourselves a break. We support each other, but we question and challenge each other’s thinking. We recruit highly skilled professionals and specialists, but we collaborate and listen to each other’s opinions and ideas. It doesn’t matter where you come from, what your