TitleDevelopment Engineer
Hours37.5 per week / full time
Reports toDevelopment Manager - Endoscopes
Reports in None
LocationOffice in line with hybrid policy
Start date September 2024
Culture of IQ Endoscopes
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 yourpurpose 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 and sustainably credible and scalable.
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 others’ 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 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 hr@iqendoscopes.co.uk.
Job purpose
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
Key responsibilities
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 13485, 14001, 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.
Person specification
Experience and qualifications
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
Desirable
· 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
Competencies and personality
· 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…
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