Senior Medical Device R&D Engineer

Placements24; Lancashire; Hybrid; GBP 90,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Pension plan

Professional growth

Exposure to innovative technologies

Generous paid time off

Job summary

Placements24 is seeking a Senior Medical Device R&D Engineer to drive concept-to-market development of innovative devices in the UK. You will lead projects, collaborate with clinicians, regulatory affairs, and QA to deliver safe, compliant devices.

Responsibilities include designing mechanical systems, creating CAD models, running tests, and performing root-cause analysis to resolve design issues. The role offers a dynamic, collaborative environment with opportunities for advanced training and

Qualifications

• Bachelor's or master's degree in Mechanical or Biomedical Engineering.
• ≥6 years of experience in medical device R&D.
• Proven track record designing and bringing medical devices to market.
• Strong CAD and simulation skills.
• Knowledge of ISO 13485 and FDA standards.

Responsibilities

• Lead R&D from concept to market launch.
• Design mechanical components and assemblies for medical devices.
• Create CAD models, drawings, and specifications.
• Develop and execute test plans for prototypes and finished devices.
• Perform root-cause analysis and implement improvements.
• Collaborate with clinicians, regulatory, QA, and manufacturing.
• Ensure compliance with medical device regulations (ISO 13485, FDA).
• Prepare DHF and regulatory submissions.

Skills

Senior R&D leadership

CAD design

Regulatory knowledge

Prototype testing

Root-cause analysis

Team collaboration

Mechanical design

Education

Bachelor's or Master's in Mechanical/Biomedical Engineering

Tools

SolidWorks

AutoCAD

FEA/Simulation (e.g. ANSYS)

Job description

About the Role

Our client is a rapidly growing innovator in the medical technology sector, dedicated to improving patient outcomes through cutting-edge device development. We are seeking a Senior Medical Device R&D Engineer to join our talented team in Queenstown, Eastern Cape . This role is central to conceptualizing, designing, prototyping, and testing novel medical devices. You will work on challenging projects that span from initial ideation through to design freeze and pre-clinical evaluation. The ideal candidate will possess a strong background in mechanical engineering, product development, and a deep understanding of medical device regulations. You will collaborate closely with a multidisciplinary team, including clinicians, regulatory affairs specialists, and quality assurance personnel, to bring life-changing medical technologies to market. This position offers a unique opportunity to be at the forefront of medical innovation and contribute to advancements in healthcare technology.

Key Responsibilities

• Lead the research and development of new medical devices from concept to market launch.
• Design and develop mechanical components and systems for medical devices, ensuring functionality, safety, and reliability.
• Create detailed CAD models, drawings, and specifications for components and assemblies.
• Develop and execute comprehensive test plans for prototypes and finished devices.
• Conduct root cause analysis for design issues and implement effective solutions.
• Collaborate with cross-functional teams, including clinicians, marketing, regulatory affairs, and manufacturing.
• Ensure all design and development activities comply with relevant medical device regulations (e.g., ISO 13485, FDA QSR).
• Prepare design history file (DHF) documentation and other regulatory submissions.
• Stay current with advancements in medical device technology and industry best practices.
• Mentor junior engineers and contribute to a culture of innovation and continuous improvement.

Requirements

• Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering field.
• A minimum of 6 years of experience in medical device research and development.
• Proven track record of successfully designing and bringing medical devices to market.
• Strong proficiency in CAD software (e.g., SolidWorks, AutoCAD) and simulation tools.
• In-depth knowledge of medical device regulations (ISO 13485, FDA standards) and quality management systems.
• Experience with prototyping, testing, and validation of medical devices.
• Excellent understanding of material properties relevant to medical applications.
• Strong analytical and problem-solving skills.
• Effective communication and teamwork abilities.
• Experience with electro-mechanical devices is a plus.

Benefits

• Competitive salary and benefits package.
• Performance-based incentives and potential for bonuses.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan with company contribution.
• Opportunities for professional growth and advanced training.
• Exposure to innovative medical technologies.
• A collaborative and dynamic work environment.
• Generous paid time off and holidays.