Job ?T?itle: R&D Engineer? ( Medical Device Industry? )

Location : Minneapolis, Minnesota, USA

?Duration : Long-term Contract (W2)

Key Responsibilities :

• Participate in the design and development of medical devices, ensuring compliance with regulatory standards and internal quality systems.
• Perform detailed engineering analyses, including tolerance studies, feasibility assessments, and risk analysis.
• Develop and execute verification and validation protocols to ensure product performance and safety.
• Collaborate with cross-functional teams, including manufacturing, quality assurance, and regulatory affairs, to ensure seamless product development.
• Conduct testing and data analysis to support product improvements and troubleshoot issues.
• Create and maintain technical documentation, including design specifications, test reports, and risk assessments.
• Support process optimization and design transfer activities for manufacturing.

Qualifications :

• Education : Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• Experience : 2+ years of experience in medical device R&D or a related industry.
• Strong understanding of product development processes, including design controls and risk management.
• Familiarity with regulatory requirements such as FDA regulations (21 CFR Part 820), ISO 13485, and ISO 14971.
• Proficiency in CAD software (e.g., SolidWorks or Creo) and statistical analysis tools.
• Excellent problem-solving skills and attention to detail.
• Strong communication skills, both written and verbal, with the ability to work effectively in a team environment.

Preferred Skills :

• Experience with Class II or Class III medical devices.
• Knowledge of materials commonly used in medical device applications.
• Familiarity with software development lifecycle (SDLC) for embedded systems in medical devices.