Work Flexibility: Hybrid or Onsite

What You will do:

Responsibilities and duties

• Risk Management, Design Inputs review, Design History File Document review, Design Output Document review, V&V protocols and reports review,.

  
  
  

• Participate in Risk Management per ISO14971 to ensure the safety and effectiveness of product.

  
  
  

• Participate in design reviews during various phases of NPD or Remediation for EU MDR.

  
  
  

• Work with team to develop robust verification, validation & release strategies to ensure product compliance, safety, reliability & effectiveness.

  
  
  

What You Need:

Required skills:

• Bachelors in Mechanical/Biomedical/Biotech Engineering.

  
  
  

• Good analytical and problem-solving skills.

  
  
  

• Basic Knowledge of EU MDR.

  
  
  

• Good understanding of Quality Management Systems. (ISO 13485, 21 CRF 820)

  
  
  

• 3-7 years of relevant work experience.

  
  
  

• Experience on NPD process and various phases of new product development.

  
  
  

• Knowledge of ISO 14971, IEC 62366, 60601-1 family of standards

  
  
  

• Expert-level knowledge of current industry standards for New Product Development and risk management practices.

  
  
  

Preferred Skills:

• Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams.

  
  
  

• Change Management

  
  
  

• QMS