KEY AREAS OF RESPONSIBILITY
• Lead new product introduction projects and associated R&D
• Lead design control activities, including design reviews, risk management, and verification and validation activities.
• Contribute to 510(k) submissions and support biomechanical/clinical testing.
• Manage critical suppliers and facilitate the necessary verification and validation activities.
• Provide mentorship and elevate the capabilities of the organisation.
• Support quality to ensure that all product design, development, and manufacturing activities comply with quality system requirements.
QUALIFICATIONS
• Bachelor’s degree (Level 8) in engineering, science, or related field.
• At least 3-years’ experience in a product development role in the medical device industry.
• Experience in understanding the verification and validation requirements for Class I & II orthopedic medical devices
• Proficiency in Solidworks or similar CAD software.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team in a start-up environment.
• Attention to detail and organisational skills are essential to this position.
Preferred qualifications:
• 5+ years’ experience in mechanical design of medical devices.
• Proficiency in Design for Manufacturing and GD&T.
• Experience launching orthopedic trauma devices
No relocation assistance offered for this position.
Phil Kemp
Chief Operating Officer
philip.kemp@x-bolt.com