Design assurance engineer Work, Jobs in Keele, Sts (with Salaries)

Design Assurance Engineer
Biocomposites —Keele
- Full-time
- Engineering
- Bachelor's degree
- Communication skills
- Free parking
- Employee discount
Quick apply
19h
Design Engineer
Aerofoil Energy Ltd —Macclesfield
- £29,000 - £49,000 a year
- Full-time
- Engineering
- Bachelor's degree
- In-person
- Free parking
- Employee stock ownership plan
Quick apply
6d
Junior UX / UI Designer
Radius Limited —Crewe
- Full-time
- University
- Communication skills
- Employee assistance programme
Quick apply
6d
Engineer
Ringway Jacobs —Crewe
- Civil engineering
- Mentoring
- Employee assistance programme
- Employee discount
Quick apply
Site Engineer - Stoke-on-Trent
Caddick Construction Ltd —Stoke-on-Trent
- Full-time
- AutoCAD
- Engineering
- Microsoft Office
- Annual leave
- Employee assistance programme
Quick apply
16h
Lead Data Engineer
Radius Limited —Crewe
- Full-time
- Mentoring
- Leadership
- Employee assistance programme
Quick apply
DevOps Engineer
Radius Limited —Crewe
- Full-time
- AWS
- Agile
- Employee assistance programme
Quick apply
Wiring Technician
Dalkia —Stone
5d
Improvement Engineer
Epson —Telford
- £39,676 - £41,264 a year
- Full-time
- Schematics
- Computer literacy
- Engineering
- Free parking
- Sick pay
Quick apply
Design Project Manager
OCU Group —Stafford
- Full-time
- Hybrid work
- Organisational skills
- Communication skills
Quick apply
3d
Highway Assurance Engineer
Cheshire East Council —Crewe
- £41,771 - £48,072 a year
- Full-time
- Hybrid work
- Engineering
- Continuous improvement
- Travel
- Annual leave
- Employee assistance programme
Maintenance Manager (Mechanical Lead)
Marshalls PLC —Keele
- Full-time
- Engineering
- Maintenance
- Team management
- Employee discount
Quick apply
4h
Quality Engineer
HydraSpecma —Stoke-on-Trent
- Quality control
- Travel
- Communication skills
Senior Mechanical Design Engineer
Unipart —Crewe
- Up to £48,000 a year
- Full-time
- Engineering
- No degree
- Work from home
- Employee assistance programme
Quick apply
3d
Technical Manager
Ibstock Plc —Stoke-on-Trent
- Computer literacy
- Continuous improvement
- Organisational skills
- Employee assistance programme
- Employee discount
6d
Regional Engineer
MGF —Rugeley
- Full-time
- Business development
- Bachelor's degree
- Communication skills
- Free parking
- Annual leave
Quick apply
4d
Site Manager - Stoke-on-Trent
Caddick Construction Ltd —Stoke-on-Trent
- Full-time
- Microsoft Word
- First Aid Certification
- Contracts
- Annual leave
- Employee assistance programme
Quick apply
1d
Mechanical Assembly Technician
Rapiscan —Stoke-on-Trent
- Schematics
- Engineering
- Forklift
IT Cloud Engineer
Places for People —Northwich
- £40,000 - £45,000 a year
- Hybrid work
- In-person
- Communication skills
- Annual leave
- Employee discount
Mechanical Assembly Technician
OSI Systems, Inc. —Stoke-on-Trent
- Schematics
- Engineering
- Forklift

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design assurance engineer jobs near keele, sts

Design Assurance Engineer

Biocomposites -
Keele

Quick apply

Job details

Full-time
19 hours ago

Benefits

Free parking
Company pension
Company events
Free or subsidised travel
Employee discount
On-site parking

Qualifications

Document control
Stakeholder liaison
Engineering
Internal department liaison
Quality management
Microsoft Office Suite
Bachelor's degree
Product development
Risk management
Document control software
Multidisciplinary collaboration
Design documentation
Hazard analysis
Document management
Document management systems
Project management experience
Communication skills
ISO 13485
Project progress tracking

Full job description

Job Description

Biocomposites is an international medical devices company that engineers, manufactures, and markets world leading products for use in infection management in bone and soft tissue. Based in Keele, UK, it has global operations across Europe, USA, Argentina, Canada, China, and India. Biocomposites is a world leader in the development of innovative calcium compounds and bone cements for surgical use. Its products regenerate bone and target infection risks across a variety of specialties, including musculoskeletal infection, orthopaedics, trauma, spine, foot and ankle, podiatry, and sports injuries. Biocomposites products are now used in over one million procedures per annum and sold in more than 100 countries around the world.

Job Summary

The Design Assurance Engineer will be responsible for coordinating and implementing design controls for medical device changes and new product developments, aid regulatory projects, research projects and technical projects. This will include maintaining and the Design Dossier (Design History File) and related Technical Documentation according to regulatory and QMS requirements.

Reports to

Design Assurance Manager

Location & Working pattern

Primary working location: Keele office (IC4/5). Office- based role.

Standard working hours: Monday-Friday, 09.00–17.00 / 08.00-16.00

Duties & Responsibilities

Maintain and manage compilation of design documentation for global products across the product lifecycle, from product conception through to retirement in accordance with specified regulatory, quality and business requirements.
Conduct Risk Assessments, including Hazard Analysis and Risk Management, and ensure appropriate risk mitigation strategies are implemented throughout the design process and product lifecycle.
Track design control project status, chair meetings (e.g. design reviews) and ensure actions are allocated to appropriate members of the design team.
Coordinate and manage Biocomposites’ design control process and systems in line with ISO 13485 requirements including SOPs, Templates, Forms and Reports for Design Inputs, Design Outputs, Design Reviews, Design Transfer, Design Verification and Validation, Design History File, Device Master Record and Design Master File.
Liaise with SMEs (subject matter experts) in the business to ensure all design and development tasks are completed in line with applicable requirements.
Lead design teams through the design process from concept planning through to completion of design transfer to production.
Analyse processes, design and implement product changes and improvements using data obtained through design control.
Liaise with quality, regulatory and technical teams to assess product usability and safety throughout the design and development process, including end user usability testing as required.
Provide support for activities falling under the remit of the Quality, Technical, Research and Regulatory Affairs teams regarding product design, development and technical documentation.
Support internal and external audits, inspections and regulatory assessments, ensuring compliance with applicable regulations and standards.

Essential requirements

Bachelor’s Degree in a Mechanical, Engineering, life science or equivalent
3+ years design control or other design/research project management in a regulated environment
Project management skills and an ability to work to tight timelines
Working knowledge of ISO 13485
Exceptional project management and teamworking skills
Enthusiastic and eager to learn, motivated to develop a career within design of Medical Devices
Proficient in the use of Microsoft Office
Excellent communication skills when liaising at all levels within the company and with external customers
Commutable to the office and able to work (Mon-Fri, 9am-5pm/8am-4pm)

Desirable requirements

Medical Devices design training or ISO 13485 internal auditor qualification
5+ years design control or other design/research project management in a regulated environment
Experience working in medical devices, pharma, automotive or aerospace manufacturing
Knowledge of electronic document management systems
Specific knowledge of ISO 13485 design control requirements
Working knowledge of medical device regulations globally
Ability to present and chair meetings with senior board members

What do we offer?

Competitive salary and benefits! With us, you will receive a competitive salary package and benefits.

We grow talent. At Biocomposites we create opportunities to thrive and grow.

One Biocomposites – team spirit & engagement. Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions.

Who do we look for?

People who are passionate about what we do.

People who are open minded to evolving the way we work.

People who can work together to transform outcomes and change lives.

Benefits:

Company events
Company pension
Employee discount
Free or subsidised travel
Free parking
On-site parking

Quick apply

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design assurance engineer jobs in keele, sts

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