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.
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Senior Medical Device R&D Engineer employer: Placements24
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