Senior Medical Device Engineer

Charfield, UK           ·            Full time

Locations: Charfield, UK

Time type: Full time

Job requisition id: R5578

Job Description

Renishaw Neuro Solutions Ltd. are looking for an experienced Senior Medical Device Engineer to join the product development team. As part of a larger team you will work within our drug delivery programme to establish a design history file (DHF) for a complex multi-disciplinary product, working from requirements capture through to full verification and validation of product performance, moving on to establish, verify and/ validate their manufacturing processes.

Responsibilities

• Requirements capture to establish user and design inputs ensuring they can be verified and validated.
• Creation and execution of design verification and validation protocols working internally in our lab or through subcontract test houses.
• Critical review of design output through creation of design review and user, design and process risk assessment documentation.
• Development of processes to support design control activities
• Support the maintenance of the QMS

Key requirements

• A degree in Medical/ Mechanical Engineering or similar relevant subject
• A proven track record in medical product design, working on complex multi-disciplinary systems. Minimum 5 years’ experience.
• Experienced in the compilation of medical device (or combination product) DHFs which are clearly structured, flexible to technical change and auditable.
• Detailed practical application of ISO-13485, ISO-14971, EU-MDR and FDA 21 CFR.
• Good knowledge of current manufacturing techniques and technology, including DfM, DfA, DfI
• A natural ability to plan, identify critical paths and resolve problems
• A natural aptitude towards structured problem-solving and decision-making
• Ability to write clear and concise reports
• Proficiency in MS applications e.g. Excel, PowerPoint
• Ability to work both autonomously and as part of a team

Desirable requirements

• Experience in 3D CAD packages to create designs and detailed drawings (ideally Siemens NX and Teamcenter)
• Familiarity with geometric tolerance definition and understanding
• Ability to create FEA models and make recommendations from the results
• Specific training will be provided on RNS products and key processes as required
• Experience of executing lab based testing as part of design verification studies
• Matlab programming
• Minitab statistical software use to support design verification activities
• Knowledge of usability engineering/ human factors assessment
• Knowledge of Biocompatibility assessment
• Knowledge of sterilisation validation for radiation/ moist heat processing

Person specification

The successful applicant will have a high level of personal discipline and motivation, with a strong sense of responsibility. They will be self-starting and highly organised in their approach to meet the product design needs, being driven to meet deadlines and achieve targets. A strong communicator and influencer, they will be able to prioritise work effectively.

Hybrid working

The successful applicant will have options for hybrid working, where you will be required to attend the office but have the opportunity to work from home for a portion of the week.

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 4 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.

Please click here for further information about our benefits.

At Renishaw we believe that our success is powered by welcoming a workforce of diverse and talented people. Through encouraging an inclusive culture, where all our employees are free to be themselves, we can achieve our core values: Innovation, Inspiration, Integrity, and Involvement.

If you are excited about the role but feel as though you don’t meet all the requirements, we would encourage you still to apply. You might just be the right person for this role or another opportunity at Renishaw.

We are committed to providing reasonable adjustments to make interviews and jobs more accessible. Should you have any difficulty during the recruitment process, or require any reasonable adjustments please contact the recruitment team on 01453 524600 or recruitment@renishaw.com.

Please click here for further information about diversity and inclusion at Renishaw.

Employment Type: Permanent

Time Type: Full time

Requisition Number: R5578 Senior Medical Device Engineer (Open)

Please click here to apply.