Hybrid Medical Device Product Development Engineer

People First; Bromsgrove; Hybrid; GBP 45,000 - 65,000; Full time

Benefits offered by this job

Competitive salary

25 days annual leave + 8 bank holidays

Pension scheme

Discounted gym membership

Employee discounts and wellbeing

Healthcare Plan

Inclusive, values-driven environment

Job summary

Kimal is seeking a Product Development Engineer to join our team in a hybrid Bromsgrove/Worcester setup. You will develop and improve our Procedure Pack range, translating design inputs into technical specifications and coordinating with suppliers, Quality, Regulatory and Manufacturing.

You will apply design controls, MDR/ISO 13485 knowledge and cost-conscious engineering to deliver compliant medical devices across the lifecycle, from concept through to manufacture.

Qualifications

• Degree in Engineering (Mechanical, Biomedical, Materials) or related discipline.
• Experience with materials, fabrics and plastics used in medical device or Procedure Pack manufacturing.
• Proficiency in 3D parametric CAD software (SolidWorks or equivalent) and engineering drawing standards.
• Practical knowledge of manufacturing processes and design for manufacture.
• Experience with design control processes (design inputs/outputs, verification, validation, risk management).
• Full UK driving licence.
• Experience in medical technology or regulated industry.
• Knowledge of MDR and ISO 13485 design control requirements.

Responsibilities

• Translate design inputs into engineering requirements, product specifications and technical documentation.
• Evaluate, validate and introduce new products from concept through to pre-launch.
• Assess third-party components, materials and medical devices against regulatory requirements.
• Identify cost-reduction opportunities, product consolidation and continuous improvement.
• Maintain product specifications, drawings, BOMs and data sheets in line with regulatory requirements.
• Support MDR/ISO 13485 design control activities and manufacturer processes.
• Collaborate with Product Management, Purchasing, Quality and Manufacturing.
• Investigate manufacturing issues and root cause analysis, and support design changes.
• Assist in product risk assessments and regulatory submissions.

Job description

Kimal is seeking a Product Development Engineer to join our team in a hybrid Bromsgrove/Worcester setup. You will develop and improve our Procedure Pack range, translating design inputs into technical specifications and coordinating with suppliers, Quality, Regulatory and Manufacturing.

You will apply design controls, MDR/ISO 13485 knowledge and cost-conscious engineering to deliver compliant medical devices across the lifecycle, from concept through to manufacture.