Title Production Engineer
Hours 37.5 per week / full time
Reports toUK Manufacturing Lead
Reports in None
Location Remote: travel required to Head Office in Chepstow and CMO organisations currently located in Mildenhall and Ashford. To discuss during interview.
Start date ASAP
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 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: Design and deploy high quality sustainable single use endoscopes
STRATEGY: 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
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
This role exists to build, maintain and enhance the relationships between IQE and their contract manufacturing organisations. You will be the IQE Technical representative on site at the Contract Manufacturing Organisation (CMO) facilities when required, as well as the CMO’s first point of contact for all manufacturing issues, supporting the CMO to deliver production builds on time and budget.
You will be required to take the lead role in facilitating design transfer, continuous improvements and cost reduction activities with the CMO.
Key responsibilities
The main responsibilities and activities for this post holder include:
· The primary IQE technical contact onsite at CMO
· Support continuous improvement and cost reduction activities
· Support engineering group in prototype builds, material selection, DfM studies
· Contribute to component manufacturing process selection
· Review and approve design packs (BOM/2D drawings/3D drawings)
· Design transfer lead
· Support the CMO in carrying out assembly trials
· Support the CMO to ensure compliance with all safety regulations and ISO procedures and standards
· Assist the CMO in Manufacturing Process Development
· IQE pFMEA lead
· Review process validation protocols and reports
· IQE expert on CMO manufacturing and packaging process
· Monitor process yields and efficiencies
· Ensure end product meets IQE quality requirements and specifications
· Contribute to root cause investigations and corrective action implementation
· Support CAPA and change control processes
· Support inspection method development
· 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
· Thorough knowledge of manufacturing and assembly processes and concepts
· Minimum of 3 years manufacturing experience; including
· Strong demonstrable experience of working with and managing relationships with sub-contractors / suppliers
· pFMEA
· Developing manufacturing process documentation
· Mechanical and Electrical device assembly specific skills
· Computer Skills: Microsoft Excel, Microsoft Word, Visio, Microsoft Access, Microsoft Project, AutoCAD, Label software and ERP Systems
· Basic CAD skills (preferably Solidworks)
Desirable
· Injection moulding / Mould tool validation experience
· Experience in the medical device manufacturing industry strongly preferred
· Statistical techniques for manufacturing
· Measurement Systems Analysis
· Experience in reviewing technical drawings
· Process capability analysis
Competencies and personality
· Prepared to work on site at CMO’s facilities on a regular basis and travel as required to meet the needs of the job. This may include regular overnight stays
· You are a collaborator with a desire to interact and work with colleagues to achieve shared Company goals
· You have strong analytical and negotiation skills enabling you to influence at all levels while maintaining strong working relationships
· You have the ability to perform a multi-task job and adjust priorities as appropriate work independently uncovering and completing your own tasks without management directive
· You drive continuous improvement and inspire colleagues to do the same
· You have the ability to communicate effectively and influence at all levels of the business
We work together to achieve shared goals through our values…
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