Ophthalmic Mechanical Lead: Lifecycle & Verification

Rayner; Worthing; On-site; GBP 65,000 - 90,000; Full time

Benefits offered by this job

On-site Restaurant

Private Healthcare

Monthly Massages

On-site Parking

Annual Wellbeing Reimbursement

Pension Plan

Cycle-to-work Scheme

Enhanced Parental Pay

Referral Bonus

Job summary

Rayner is seeking a Senior Mechanical Development Engineer to lead the technical direction for a portfolio of ophthalmic surgical devices, including Phaco accessories and VR instruments. You will own design development, verification, and lifecycle management, ensuring compliance with medical device regulations.

You will collaborate with suppliers and cross-functional teams to deliver high-precision mechanical components and robust product releases, maintaining DHFs and leading design transfers.

Qualifications

• Degree in Mechanical Engineering, Product Design Engineering, Biomedical Engineering, or a related discipline.
• Strong understanding of design control and medical device development processes.
• Experience creating and maintaining Design History Files (DHFs).
• Experience leading engineering projects involving supplier qualification or manufacturing transfer.
• Demonstrated experience planning and executing product verification testing.
• Strong experience producing engineering documentation and technical reports.
• Proficiency in CAD and engineering drawing standards.
• Hands-on approach to problem-solving, root cause analysis, and technical decision-making.
• Excellent stakeholder management and communication abilities.
• Experienced in design and development of ophthalmic surgical devices, phacoemulsification systems, surgical instruments or disposable medical devices, sterile barrier packaging.
• Experienced in high precision metal component design, CNC machining, and testing.
• Experienced in small plastic component design, injection moulding, vacuum form moulding and testing.
• Experience of working with international suppliers and contract manufacturers.
• Understanding of process validation, and process qualification activities.
• Familiarity with ISO 13485, ISO60601-1/2, ISO 80601-2-58, ISO 62366, and packaging standards.

Responsibilities

• Acts as the technical lead and subject matter expert for the Phaco accessory and VR instrument portfolio throughout the product lifecycle.
• Leads mechanical design and development of new products from concept through design transfer and release.
• Owns product performance, manufacturability, reliability, and design improvements.
• Supports product lifecycle management including design changes and obsolescence management.
• Provides technical leadership for cross-functional project teams.
• Delivers and reports on work packages within Design Control procedures.
• Creates and maintains DHFs per procedures and medical device regulations.
• Defines verification strategies and acceptance criteria; develops verification protocols and test methods.
• Maintains professional knowledge through training and industry engagement.

Skills

CAD proficiency

Engineering drawing standards

Problem-solving

Root cause analysis

Stakeholder management

Communication skills

Technical decision making

Education

Bachelor's degree in Mechanical Engineering

Tools

CNC machining

Injection moulding

Vacuum forming

Job description

Rayner is seeking a Senior Mechanical Development Engineer to lead the technical direction for a portfolio of ophthalmic surgical devices, including Phaco accessories and VR instruments. You will own design development, verification, and lifecycle management, ensuring compliance with medical device regulations.

You will collaborate with suppliers and cross-functional teams to deliver high-precision mechanical components and robust product releases, maintaining DHFs and leading design transfers.