Graduate / Junior Quality & Product Development Engineer — Medical Devices - #2194599

Location: Manchester, UK

Employment type: Full-time, permanent

Salary: £34,000–£40,000 per annum, depending on relevant experience, with a salary review after six months.

About ISOBAR

ISOBAR designs and manufactures personalised compression therapy systems incorporating compression dose management technology for the health, sports and travel markets.

Our on-demand manufacturing process combines specialist flat-knit technology with digital systems to create technically knitted garments matched to individual customers.

We are looking for a motivated graduate or early-career engineer to help coordinate this market-entry programme while contributing to quality assurance, product testing and manufacturing improvement.

The role

You will coordinate programme activities and deliver defined work packages under the supervision of an experienced internal lead or retained adviser.

Your work will include maintaining project schedules, organising testing, preparing controlled documentation, analysing results and following up actions across manufacturing, software and external specialists.

You will receive structured training and progressively take on greater responsibility as your skills develop. Regulatory strategy, test protocols, technical conclusions and market-release decisions will be reviewed and approved by the designated experienced lead or adviser.

This is a practical development role combining detailed quality work with hands-on involvement in manufacturing and product development.

Key responsibilities

Coordinate the market-entry programme

• Maintain the programme schedule, action register and document tracker.
• Track deliverables, dependencies and deadlines, and flag delays or evidence gaps to your supervisor.
• Organise project meetings, record decisions and follow up agreed actions.
• Coordinate samples, information and documentation between internal teams, laboratories and external advisers.
• Prepare progress updates for management, identifying decisions requiring senior review.

Support quality systems and technical documentation

• Help develop and maintain quality procedures, work instructions, inspection records and product specifications.
• Prepare and organise evidence for the EU MDR technical file and FDA design and development records, including documents commonly described as the Design History File.
• Maintain traceability between approved requirements, identified risks, test activities and results.
• Support document control, supplier records, training records and change-control activities.
• Help prepare labels, instructions for use and registration information for specialist review.
• Support internal audits and follow up assigned corrective actions.

Coordinate product testing and development

• Support prototyping, manufacturing trials and the preparation of representative test samples.
• Coordinate compression-performance and wash testing with SMTL against the agreed requirements of BS 661210:2018+A1:2022.
• Draft test plans and protocols using approved templates, for review before testing begins.
• Check that laboratory reports are complete, summarise results and highlight deviations or failures.
• Support investigations and repeat testing under approved plans.
• Help coordinate material and biological-safety assessments with external specialists.

Support measuring-app validation

• Work with software and measurement specialists to organise accuracy and repeatability studies.
• Coordinate study participants, supported phones, test conditions and data collection under approved protocols.
• Check measurement records, units, patient/order matching and the transfer of dimensions into manufacturing.
• Support end-to-end trials linking app measurements to finished-stocking fit and performance.
• Maintain records of the app and manufacturing-system versions used in testing.
• Track privacy and cybersecurity actions assigned to the responsible specialists.

Support manufacturing quality and improvement

• Inspect products against approved specifications and record results accurately.
• Help establish consistent inspection and manufacturing records.
• Support process validation and the transfer of new or improved products into manufacture.
• Investigate quality issues using structured root-cause analysis, with guidance where needed.
• Implement assigned corrective and preventive actions and monitor their effectiveness.
• Analyse inspection results, remake rates and complaints to identify trends.
• Support traceability checks, recall exercises and post-market data collection.

About you

You will be practical, analytical and organised, with an interest in manufacturing and personalised healthcare products. You should enjoy solving problems, maintaining accurate records and working with colleagues from different technical disciplines.

Essential skills and qualities

• A degree, or equivalent technical qualification or experience, in engineering, biomedical engineering, manufacturing, materials science, product development or a related discipline.
• Strong analytical and problem-solving skills.
• An organised approach, with attention to detail and the ability to manage several assigned activities.
• Clear written communication and confidence preparing technical records and reports.
• Confidence using spreadsheets to organise information and analyse results.
• The ability to work collaboratively, follow approved procedures and ask for guidance when needed.
• A willingness to learn, take ownership of agreed actions and communicate problems promptly.

Desirable experience

Experience gained through a placement, internship, university project or previous employment in any of the following would be beneficial:

• Quality assurance, manufacturing or product development.
• Medical devices or another regulated industry.
• Product testing, measurement studies or statistical analysis.
• Controlled documentation, risk assessment or quality investigations.
• Technical textiles, knitting or compression garments.
• Software testing, digital measurement or manufacturing systems.
• Coordinating projects, suppliers or laboratory activities.

Previous experience with ISO 13485, EU MDR or FDA requirements is welcome but is not essential. Training and specialist support will be provided.

Supervision and development

You will have a named supervisor and access to experienced regulatory and technical advisers.

Your development will include:

• Regular mentoring and programme reviews.
• Training in medical-device quality systems, risk management, testing and technical documentation.
• Review and feedback on protocols, reports and other controlled documents.
• Clear boundaries for activities you can complete independently and decisions requiring approval.
• A salary review after six months and a development review after twelve months.

You will be responsible for completing assigned activities accurately and escalating issues. Final regulatory and market-release approvals will remain with the designated experienced lead and ISOBAR management.

What we offer

• A varied role combining quality engineering, product development and programme coordination.
• Hands-on experience with advanced knitting, manufacturing and digital measurement technologies.
• The opportunity to contribute to personalised healthcare products and international market entry.
• Structured training, mentoring and professional development.
• Increasing responsibility as your competence develops.

How to apply

Please send your CV and a short covering letter to [email protected]

Please include:

1. An example of a testing, quality, manufacturing or product-development project you contributed to.
2. A problem you investigated and how you approached it.
3. An example of how you organised tasks, maintained records or followed up actions.

Examples from university projects, placements and internships are welcome.

ISOBAR is committed to creating an inclusive workplace and welcomes applications from candidates of all backgrounds.