- Product Design and development of medical devices from concept to market release
- Compiles DHF (product design, specifications, dfmea, design testing, verification, validation, usability)
- Lead's project's actions in UK and Manufacturer (design transfer)
- Provides engineering requirement for ECO's
- Maintains allocated legacy DHF's
- Verification and validation of components and assemblies. (ISIR and appropriate testing, as required)
- Records all formal and relevant informal engineering information in the plm system
- Modification/amendment of new/existing drawings in accordance with design standards
- Other reasonable duties which you may be requested to perform from time to time by your manager
- Degree in Product Design or Engineering
- Experience in a product Design Related Role or Manufacturing Environment
- Solid Edge / Solid Works
- Plastics and Injection Mould Design
- Proven ability to apply the know-how and experience in a creative way
- Strong decision-making skills
- Excellent communication skills - both written and oral
- Self Motivated
- Ability to meet deadlines, work independently, plan and prioritise
- Ability to be flexible/ adapt as daily schedule may change rapidly
- Strong organizational skills & ability to multi-task
- Accuracy and attention to detail
- Ability to follow written guidelines
- Ability to exercise good judgment in recognising scope of authority
- Tact and discretion, for dealing with confidential information
- Problem solving techniques (i.e. DFMEA / Risk Analysis)
- Experience in compilation of usability engineering file
- Compilation of a Technical File
- Design requirements of extruded/moulded parts
- Understanding of ISO13485:2003/MED DEV 93/42/EEC and or FDA regulations
- Experience of working with a Product Life-Cycle Management System and/ or working with an ERP System is highly desirable.
- Project Management
- Bill Of Materials Creation and Management
- Understanding of FDA Regulations
- Knowledge of international standards and regulations, including EN 62366, ISO13485, ISO9001, EN60601, EN62304, ISO10993, ISO14971 and the Medical Devices Directive (93/42/EEC)
- Electronics experience
- Competitive salary
- Balanced working (up to 4 days a month working from home)
- Annual Company performance bonus
- 3% ER, 5% EE pension
- 25 days holiday (plus bank holidays)
- Holiday trading scheme
- Early finish on a Friday
- Free on-site parking
- 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.
- Employee Referral Scheme
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Design Engineer - Mountain Ash, United Kingdom - Flexicare (Group) Limited
2 weeks ago
Description
Job Description
Company Description
Flexicare, with over 40 years of experience, is a leading designer and global provider of innovative medical devices. Headquartered in the UK, Flexicare has a global network of 17 subsidiaries supporting over 105 countries. Our vision is to inspire confidence and empower clinical excellence, while our mission is to pioneer sustainable innovations and advance clinical therapies to improve patient care. Flexicare values innovation, ethical design, adaptability to healthcare needs, and a positive and inclusive culture.
Role Description
This is a full-time on-site role for a Design Engineer located at our HQ in Mountain Ash. As a Design Engineer at Flexicare, you provide technical capability for the design and development of new and existing medical devices, from concept to volume manufacturing, in accordance with legislation and internal procedures. This will include the generation of life cycle documentation and developing usability engineering files for new product developments. You will collaborate with cross-functional teams to develop and enhance innovative medical devices.
Main Duties
Qualifications / Experience / Skills /Aptitude
Essential
Desirable
What we offer
