Engineering Project Leader

Key Job Responsibilities and Functions:

• Lead engineering activities, reporting directly to the Engineering Project Manager
• Spearhead verification and validation activities, including planning, protocol development, and reporting
• Conduct and oversee bench testing and produce comprehensive reports
• Drive design and development activities, including design of experiments, device improvements, and risk analysis
• Develop and optimize manufacturing processes
• Implement and maintain manufacturing process controls
• Lead transfer to production activities, new product introduction (NPI), and process validation initiatives

Competency Requirements:

• Must have familiarity with medical device regulatory environments (ISO13485, FDA) and ISO14971
• Must have experience in the medical industry
• Strong problem-solving and analytical abilities
• Excellent communication skills
• Proficiency with Solidworks or equivalent CAD software
• High level of independence and sense of responsibility
• Advanced written and verbal English skills

Qualifications:

• B.Sc. in Biomedical or Mechanical Engineering
• Minimum of 2 years' experience in medical device development companies (preferred)
• Proficiency with Solidworks or equivalent CAD software
• Strong computer literacy and proficiency in various software environments