Lead Development/QMS Engineer

Lead Development/QMS Engineer - Contract - Remote within US

Proclinical is seeking a Lead Development Engineer for orthopedic minimal invasive therapy devices.

Primary Responsibilities:

This role focuses on the full life cycle development from conceptualization to commercial market launch. The successful candidate will work closely with the Chief Medical Officer to assess clinical needs and manage product development programs. This position requires strong project management skills and the ability to oversee both internal and external engineering and manufacturing resources.

Skills & Requirements:

• BS in engineering (mechanical or biomedical preferred).
• 3-5 years experience in project leadership alongside 8-10 years of hands-on product development experience, ideally in medical device product development.
• Experience transitioning a product into manufacturing and distribution.
• Knowledge of Quality Systems, Quality Assurance best practices, and Regulatory Compliance.
• Experience ensuring FDA, GMP, and ISO compliance involving Design Control and maintenance of Design History Files (DHF).
• Experience with orthopedic implant medical devices is desired.

The Lead Development/QMS Engineer's responsibilities will be:

• Lead the full life cycle development of orthopedic minimal invasive therapy devices.
• Collaborate with the Chief Medical Officer to assess clinical needs and develop design inputs and outputs.
• Manage product development programs and maintain master project schedules.
• Oversee internal and external engineering and manufacturing resources.
• Contribute to hands-on design, design reviews, and technical documentation.
• Support the creation of solid models/drawings and manufacturing prototypes.
• Support pre-clinical laboratory testing and animal studies, including protocol development and generating final reports.
• Lead Risk Management activities throughout the product life cycle.
• Analyze and evaluate product defects, perform failure investigations, and implement corrective and preventive actions.

If you are having difficulty in applying or if you have any questions, please contact Joe Dykes at j.dykes@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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