Overview:
The Metallurgist/Material Scientist uses engineering and materials science principles, helps design, develop, and execute metallurgical testing and consultation with primary focus on device safety, performance, and compliance to regulatory requirements.
Responsibilities:
Evaluation of new technologies and processes towards novel medical devices;
Feasibility testing to support the product development of medical devices;
Design verification testing to support device regulatory approval;
Post-market device evaluation to support clinical and/or marketing activities;
Challenge medical devices through accelerated fatigue, corrosion, simulative use, and basic mechanical properties medical device testing;
Develop test matrix and validate test methods;
Conduct tests compliant with various international regulatory agencies;
Maintain well-controlled documentation, including written protocols, data forms, and laboratory notebooks;
Participate in standard committees; and
Conduct research related to defining clinically relevant test conditions.
Qualifications:
Minimum of M.S. in Metallurgy, Metallurgical Engineering, Material Science, or similar field of study required, PhD preferred;
Prior medical device industry experience strongly preferred;
Skills related to fracture mechanics, processing-structure-property relationships in engineered alloys, mechanical metallurgy, fractography and surface analysis techniques are a plus;
A hard-working, enthusiastic, detail-oriented person with strong written and verbal communication skills, recordkeeping skills and interpersonal skills is needed; and
Must be able to work in a dynamic team setting and possess a willingness to be trained.