Development Engineer

Title Development Engineer

Hours 37.5 per week / full time

Reports to Development Manager - Endoscopes

Reports in None

Location Office in line with hybrid policy

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 isnt just a job to us its a passion.

We want you to be a part of our vision and to find yourpurpose within our organisation.

PURPOSE:To create pioneering endoscopy technologies for the early diagnosisof 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 and sustainably credible and scalable.

At IQ Endoscopes we work hard but we give ourselves a break. We support each other but we question and challenge each others thinking. We recruit highly skilled professionals and specialists but we collaborate and listen to each others opinions and ideas. It doesnt matter where you come from what your background or beliefs are who you love or how you express yourself. What matters is that you are you and you can be you within our team. Our inclusive culture has grown organically as a result of focusing on recruiting the right person with the right skills. Nothing else. Plain and simple.

We are a progressive organization set to disrupt the medical device industry with our innovative and pioneering design we want diversity to remain progressive we want equity to breathe our values. We are inclusive because inclusivity is how we will achieve our vision.

Talk to us if you have any ideas about how we can improve our recruitment process. We want to know.

We welcome applications from the neuro enlightened community. If you need us to run our recruitment process in a different way to get the best from your application contact the HR Manager

We are looking for an ambitious and motivated individual with a strong interest and experience in medical device development to support:

Research and implementation of technologies and design solutions into our range of single use endoscopes and associated equipment

Generating full design packages design history and risk management files to facilitate transfer to production and preparing for regulatory submissions

Design and development activities producing design control risk management and technical reports according to international standards and our internal procedures

The main responsibilities and activities for this post holder include:

Ideate develop and test new technologies and design solutions

Design mechanical electrical medical devices including design for manufacturing and design for assembly/disassembly

Perform engineering analysis on respective designs

Produce design packages including part and assembly models and drawings that can be transferred to manufacture

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

Co-ordinate with internal/external stakeholders including clinicians contract designers and contract manufacturers

Adhere to processes controlled within the quality management system

Communicate clearly and professionally to facilitate project management tasks

Work inclusively and with equity as part of your natural daily operations to ensuring our diversity keeps us progressive in terms of our ways of thinking and collaborating

Work to and comply with the principles of the GDPR and our company approach to protecting data and sensitive information

Work to and comply with all regulations standards and accreditations relevant to our business operations and our industry. This applies now and as we evolve to gain further accreditations. For example ISO UK and EU MDR Regulations and CFR 820 Code of Federal Regulations.

Key responsibilities are intended to describe the general nature and level of work relating to a specific job role or function area being performed by people assigned to this job. They are not an exhaustive list and all employees are expected to be flexible with the responsibilities they take on relevant to their job role but not defined within their job description.

Essential

A degree in mechanical engineering product design or related discipline

No less than 3 years experience in product development ideally in a highly regulated environment

Strong competency in core design methodologies and tools design documentation and change control

Proficiency in CAD and Product Data Management (this role will use Solidworks)

A strong interest and understanding of the medical device field

Demonstrated experience in user-centric design

Experience with cradle to grave product development

Experience working in an ISO 13485 environment

Experience with verification and validation of medical devices including specification of acceptable criteria test method development and validation sample size calculations and technical reporting

Familiarity with design for injection moulding and other common high volume low-cost manufacturing processes

Experience in rapid prototyping and testing cycles including use of 3D printing techniques

Experience performing root cause analysis and planning corrective actions (CAPA)

Experience with basic tolerance analysis techniques

Familiarity with risk management for medical devices ISO 14971

Well organised able to manage their own time effectively and track multiple tasks at various level of completion

Sets high standard 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 willing to work outside of your specialist area to support the wider team and business

We work together to achieve shared goals through our values