Mechanical Engineer (Medical Domain)
About the Company
AeroDel specialises in developing and implementing innovative technologies to produce disruptive medical devices and digital solutions to patients suffering from respiratory and sleep problems. Our work starts and ends with a focus on our patients, employees, and external stakeholders.
- Patient-driven problem solving: We are focused on improving the patient experience with each and every device we create.
- Healthcare expertise with respiratory focus: We are a team of entrepreneurs, pharmaceutical professionals, mechanical engineers, industrial designers, and technology enthusiasts looking to disrupt the global respiratory medical device market.
- Building innovative respiratory care models: We are looking to create a new "respiratory care" category for chronic patients using our medical IoT devices (ActiveControl).
Job Description
We are seeking a highly skilled Mechanical Engineer with experience in the medical domain to join our dynamic team. The ideal candidate will have a strong background in product design, design for manufacturing, fi nite element analysis (FEA), and a solid understanding of ISO 13485 quality management systems. The successful candidate will play a crucial role in the development of innovative respiratory medical devices, ensuring compliance with regulatory standards and optimising product performance.
- Collaborate with cross-functional teams to conceptualize, design, and develop respiratory medical devices from initial concept through production.
- Conduct feasibility studies and risk assessments to inform the design process and ensure compliance with regulatory requirements.
- Utilize CAD software to create detailed 3D models and engineering drawings for components and assemblies.
Perform fi nite element analysis (FEA) to evaluate structural integrity, thermal performance, and fl uid dynamics of medical device designs. - Apply design for manufacturing (DFM) principles to optimize product manufacturability, cost-effectiveness, and scalability.
- Work closely with suppliers and manufacturing partners to prototype, test, and iterate designs for performance optimization and manufacturability.
- Support the development and maintenance of design control documentation, including design inputs, verifi cation/validation protocols, and risk management fi les, in accordance with ISO 13485 and other relevant standards.
- Participate in design reviews, risk management meetings, and regulatory submissions to ensure compliance with applicable standards and regulations.
- Stay current with industry trends, best practices, and emerging technologies in medical device design and regulatory compliance.
Candidate Profile
- Bachelor's degree in Mechanical Engineering or related field; advanced degree preferred.
- At least 5 years of experience in mechanical design and product development within the medical device industry, preferably in the Class 2 Medical devices.
- Proficiency in CAD software (e.g., SolidWorks, Fusion 360) for 3D modeling and engineering drawings.
- Strong understanding of fi nite element analysis (FEA) techniques and software (e.g., ANSYS, Abaqus).
- Experience with design for manufacturing (DFM) principles and practices.
- Familiarity with ISO 13485 quality management system requirements and medical device regulations (e.g., FDA QSR, EU MDR).
- Excellent problem-solving skills and attention to detail.
- Effective communication and collaboration skills, with the ability to work in cross-functional teams.
- Proven track record of delivering high-quality, innovative medical device designs on time and within budget.