Sustaining Mechanical Engineer Jobs in California

Experience with quality management systems and medical device regulations

Management estimate based on product sales and average units per procedure

Support risk management activities and risk management reviews on existing products.

Knowledge of clinical applications and associated product requirements with the ability to translate these requirements into detailed specifications.

Provide R&D support for verification, qualification, and validation studies on existing products.

Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Industrial Engineering or related discipline, or related practical experience

Solid working knowledge of quality and regulatory requirements, plus experience dealing with regulatory agencies or outside professional groups (e.g. FDA,.

Experience with Agile Product Lifecycle Management System is required

Understanding of documentation system and management

Preferable knowledge of Quality System Requirements (QSR), ISO 13485, TGA, PMDA, other international regulations and compliance thereof

Strong written and verbal communication skills and attention to detail

Experience in an FDA regulated environment required

2 years minimum experience in structural design engineering.

Experience in a development life cycle with substantial system responsibility.

Proficiency in computer aided design. CATIA experience preferred.

Demonstrated knowledge and ability to integrate state-of-the-art design and manufacturing methods into product concepts and designs.

Proven knowledge and application of engineering fundamentals to root cause and solve complex engineering challenges.

Demonstrated ability to manage projects with tight timing constraints.