Product Development Engineer

Job Description

Soteria Medical is seeking a highly skilled Mechanical Design Engineer to join our growing team. You will be responsible for designing innovative mechanical and disposable medical device systems, ensuring compliance with medical device standards, and contributing technical expertise throughout the product lifecycle. This role involves working on cutting-edge medical device solutions, from early-stage prototyping to full-scale production. You will collaborate with cross-functional teams to conceptualize, design, develop, and implement cost-effective and reliable product solutions.

Key Responsibilities

• Lead the mechanical design of new diagnostic and treatment devices, including material selection, documentation, and ensuring regulatory compliance.
• Conceptualize, design, and develop mechanical components and sub-assemblies that integrate with electrical and pneumatic systems.
• Develop 3D models, configurations, and layouts of product designs using SolidWorks.
• Perform detailed mechanical engineering analyses, including tolerance analyses at both component and system levels.
• Develop and implement test and inspection methods for mechanical components and sub-systems.
• Support design control activities, including creating Design Input Requirements, conducting design and user FMEA (Failure Modes and Effects Analysis), and preparing design verification and validation documents.
• Identify critical attributes of mechanical components and define inspection criteria to ensure quality and reliability.
• Prepare technical documentation, such as engineering analysis reports, work instructions, and presentations.
• Ensure adherence to design control efforts in compliance with regulatory requirements for Class I and Class II medical devices.
• Provide technical support to quality, regulatory, and customer service teams, including conducting root cause analyses of product failures and non-conformances.

Why Join Soteria Medical

At Soteria, we pride ourselves on being a young, dynamic, and fast-growing company. Our small, motivated team thrives on collaboration and innovation, making teamwork the key to our success. By joining Soteria, you will have significant growth opportunities in a company that is already active in many international markets. You will work with customers and distributors across Europe, with potential involvement in our expanding U.S. and Asian markets.

Additionally, you will play a vital role in providing valuable customer feedback that drives future product development and helps us bring new products to market.

Requirements / Qualifications

• Education:
  • Bachelor’s degree in Mechanical Engineering or Biomedical Engineering (Master’s degree is a plus).
• Technical Skills:
  • Proficiency in SolidWorks for 3D modeling and design.
  • Hands-on experience with prototyping and maintaining QMS (Quality Management System) records.
  • Familiarity with ISO 13485 standards and 510(k) regulatory approval processes (a plus).
  • Experience in writing and executing design process documentation according to ISO 13485.
  • Experience with electro-mechanical or pneumatic system design and control systems (preferred).
  • Basic programming knowledge in C++, Java, or Python (preferred).
  • Strong proficiency in MS Office and Windows OS.
• Experience:
  • Minimum of 3 years in a professional mechanical design engineering role (1-2 years of experience with a Master’s degree is acceptable).
  • Previous experience in the medical device industry or other regulated industries is highly desirable.
• Soft Skills:
  • Fluent in English (both verbal and written).
  • Strong social and communication skills.
  • Excellent teamwork skills with the ability to work both independently and collaboratively.
  • Strong technical and analytical skills, with attention to detail.