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Development Engineer - Chepstow, Monmouthshire, United Kingdom - IQ Endoscopes Limited
2 weeks ago
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.
To create pioneering endoscopy technologies for the early diagnosis of diseases, helping people live longer & betterA world where everyone has easy access to safe, sterile endoscopy
Design and deploy high quality sustainable single use endoscopes
To enter the single use endoscopy market as soon as possible with a product range that is clinically and commercially credible, will be adapted to meet future market demands and sets the benchmark for carbon neutral responsibilities
Equity, Diversity and Inclusion at IQ Endoscopes
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 welcome applications from the neuro enlightened community.This role exists to provide hands-on technical and organisational leadership to ensure progression of design and development projects related to our Q-series of base units from concept though to regulatory approval and market release.
This is achieved through provision of technical and organisational input directly into the projects as well as through line management of direct reports who hold responsibility for key roles within the projects.
The work of the Development Manager – Base Unit feeds directly into organizational objectives meaning this post holder feeds updates on delivery of the 'project plan' as well as company objectives directly to the R&D Director ensuring key milestones are met while considering opportunity to develop Q-Series product range further.
Leading a team of multi-skilled and specialist engineers in the development and continuous improvement of our base units: Lead core development functions within the team including project management, planning, design engineering, Coordinates with cross-functional teams to ensure effective deployment of resource which placed the focus on the critical and aspirational objectives of the business in the right wayEnsure design control and traceability at each phase of a development project
Drive the design and development for the development or the Q-Series including new products to be integrated into endoscopy systems
Assist in establishing and ensuring adherence to a project plan
Lead the development and iteration of design concepts, respecting functional requirements alongside design for manufacture, electrical safety, EMC and usability and maintenance considerations
Drive product testing activities including prototype bench testing, computational analysis, evaluation verification as appropriate
Support the manufacture process design, verification and validation, and associated risk management
Support regulatory submissions and audits including TGA registration, CE marking and FDA submissions
Source suppliers and contractors as required, develop and maintain relationships
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
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.
Bachelor's degree or equivalent in a relevant engineering discipline~ Experience working in highly regulated medical device or other highly regulated engineering environments
~experience in medical device product development, preferably endoscopy. Or other highly regulated product development environments
~3+ years experience developing multi-disciplinary systems that involve electronics, embedded software, optical and mechanical components – exposure to full development life cycle
~ Strong technical knowledge and understanding in at least 2 of the above disciplines, preferably strongest in a combination of electronics, embedded software or optical. Mechanical with at least one of the other 2 also considered
~ Knowledge of Project Management Techniques
~ Knowledge of Risk Management procedures
~ Knowledge of Regulatory and Quality System Requirements.
~ Ability to propose and execute on product development testing activities (formative testing, verification)
~ Excel, Matlab, statistics)
~ Expertise in 3D CAD design (e.g. SolidWorks or similar)
~ Familiarity with medical image processing techniques
~ Knowledge of Software development procedures and practices (embedded software)
~ Competencies and personality Attention to detail and appropriate respect for operating in highly regulated development environment
~ Hybrid working usually on site Tues - Thurs.
~ 25 days annual leave plus bank holidays
~2 'Disconnect Days' following probation
~2 additional days paid dependents leave: entitlement from day 1
~ Paid compassionate leave:
entitlement from day 1
~ Enhanced pension 5% paid by employer & 3% employee
A cashback service for both essential and non-essential health and well-being treatments (plan detail attached, level 1 is company funded)
GP Anytime: 24/7 access to a phone or chat based GP
EAP Service: 24/7 phone and web chat access to professionals who can advise on a range of topics such as housing, relationships, legal advice, financial advice and mental health support
Face to face counselling:
referral where required through our EAP line and a fully funded programme of up to 8 sessions.
Access to online health screening
Access to online physiotherapy
~ Refer a friend bonus £750: paid £250 following 3 months and £500 following further 3 month of your referrals' employment
