Design Engineer

Flexicare Global; Mountain Ash; On-site; GBP 40,000 - 60,000; Full time

Benefits offered by this job

Competitive Salary

Pension

33 days Holiday per year incl Bank Hol

Benefits package: Life Assurance, 50%?

Job summary

Flexicare Global is hiring a Design Engineer in the UK to drive development of medical devices from concept to volume manufacturing, ensuring compliance and robust design.

You will coordinate with manufacturing for design transfer, lead risk assessments, and create DHF/verification documentation, while using PLM systems and CAD tools to deliver qualified products.

Qualifications

• BSc. Degree in Product Design, Engineering or related field.
• Experience with DFMEA/ risk analysis.
• Experience compiling technical files and design history.
• Knowledge of design requirements for extruded and molded parts.
• Familiarity with ISO 13485/MED DEV 93/42/EEC and/or FDA regulations.
• Experience with PLM/ERP systems and BOM management.

Responsibilities

• Develop medical devices from concept to market release.
• Ensure robust design with risk and safety management.
• Compile DHF with design, testing, verification and usability docs.
• Lead UK project actions and coordinate design transfer.
• Verify and validate components and assemblies (ISIR tests).
• Record engineering information in the PLM system and update drawings.

Skills

Problem solving

Design thinking

Statistical analysis

Education

BSc. Degree in Product Design or Engineering

Tools

SolidWorks

Creo

PLM/ERP BOM

Job description

Founded in 1989, Flexicare is a global medical device company specialising in airway management and respiratory solutions, supported by a complementary portfolio that extends across critical care, respiratory technique and urology, giving us on the of the broadest ranges in our sector.

Become Part of the Team

As Design Engineer you will provide technical capability for the development of new medical devices, from concept to volume manufacturing, in accordance with regulations and internal procedures . This includes generation of product life cycle documentation and development of usability engineering files for new product developments.

What You'll Do

• Development of medical devices from proven concept to market release
• Responsibility for ensuring robust design, system-level thinking, risk and safety management, and performance/cost/compliance trade-offs.
• Compilation of Design History Files (DHF), including product design, specifications, DFMEA, design testing, verification, validation, and usability documentation
• Lead project actions in the UK and coordinate with manufacturer for design transfer
• Conduct verification and validation of components and assemblies (including ISIR and appropriate testing)
• Record all formal and relevant informal engineering information in the Product Lifecycle Management (PLM) system
• Create and amend new/existing drawings in accordance with design standards

We believe you're the right fit if you have

• BSc. Degree in Product Design, Engineering or other science related qualification
• Problem solving techniques (e.g. DFMEA / Risk Analyasis)
• Experience in compilation of Technical files
• Knowledge of design requirements for extruded and moulded parts
• Understanding of ISO 13485:2003 / MED DEV 93/42/EEC and/or FDA regulations
• Experience working with Product Life-Cycle Management (PLM) or ERP systems Bill of Materials (BOM) creation and management
• Use of Solid Works, Creo or another 3D CAD package.
• Application of statistics and engineering mathematics to inform robust design.

Desirable but not essential experience

• Experience in compilation of usability engineering files
• Basic understanding of electronics
• Experience of using Ai to enhance productivity

What You'll Get

• Competitive Salary in accordance with experience and capabilities
• Pension
• 33 days Holiday per year incl Bank Holidays
• Benefits package: Life Assurance (x2), Income protection (50% of salary), Health Cashplan (Medicash), Benefit pot - for spending on additional benefits, which include: Upgrade Health Cash plan, Critical Illness cover, Cycle to work, Tech Benefits, Will Writing, or add it to your pension pot if not used.

Due to the high volume of applications anticipated for this role, we regret that we will only contact candidates selected to progress to the next stage of the recruitment process.