Overview
A vacancy has arisen for a Senior Medical Device Engineer. As the successful candidate you will be required to provide design and development engineering support for new and current projects.
You will support our drug delivery products program team as it supports our customers through clinical trials, investigating new drugs and therapies for debilitating neurodegenerative and neurooncological conditions.
Key tasks will include:
(i) support the creation of the design history file taking development product towards verification and validation activities ahead of clinical trials and market submission in both EU and US territories (initially)
(ii) work closely with other design development team members and production departments to identify and make improvements to the DfM activity with the aim to provide improvements to quality, yield and cost reduction activities.
(iii) undertake design, protocol generation, reporting using the framework of our ISO 13485 quality management system.
Additional tasks will include concept generation, literature review, generation and review of product non-conformance reports, CAPA, risk management, design verification and validation reports and design change documentation.
This role offers the opportunity to gain competences in a unique multidisciplinary technology environment.
Responsibilities
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Work autonomously under the technical lead against a given design brief
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Generate DHF content for new product lines
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Provide input and support to the design and development teams
Key requirements
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High level degree in a suitable STEM subject, such as mechanical engineer, biomechanics/ bio-medical engineering, manufacturing engineering or other appropriate experience
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Working knowledge of ISO13485, ISO 14971
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Experience in a medical device design & development engineering role
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Knowledge of DFM
Desirable requirements
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Working knowledge of ISO 10993, ISO 11737
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CAD and drafting experience (Siemens NX Unigraphics preferable though training will be provided)
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Experience of test design and statistical techniques for design verification/ validation
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Experience in nonconforming product management, CAPA and design change activities
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Knowledge of additive manufacturing techniques
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Knowledge of sterilisation validations
Person specification
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Excellent written skills (e.g. protocol, report writing)
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Excellent communication skills
Benefits
When you join Renishaw, we’re committing to your future career. That’s because we believe in developing our people’s skills and promoting them internally. We also offer a benefits package that’s highly desirable; including a 9% non-contributory pension, discretionary annual bonus, *subsidised onsite restaurants and *coffee shops, free parking, *car sharing scheme and *24 hour fitness centres. (*not available at our Castle Donington, Exeter, York & Edinburgh sites)
We also want to promote a healthy work-life balance as much as possible, so we have introduced a Homeworking policy which allows for a combination of home and office based working depending on the nature of your role. We also offer a variable working programme, 25 days holiday plus bank holidays, Life Assurance policy of 12 times annual salary, Cycle to Work scheme, enhanced maternity pay subject to qualifying criteria, the option to join BUPA Renishaw health trust and an Employee Assistance Programme for employees and family.
This job was originally posted as: https://thecareerwallet.com/stats/track/MTQ1MjI2NTg1Ni18LTE0NS18LTcw