Our client is currently seeking a Senior Engineer - Product Support Engineering for a 12 month + contract.
A Sr. Product Support Engineer (PSE) will need to work closely with our Quality Assurance, Global Quality and Operations (GQO) counterparts to support the Change Control, CAPA and NCR project portfolio, Perform implant and instrument design work and Actively participate on, and sometimes lead, multifunctional teams to advance assigned projects through continuous improvement initiatives.
Essential Duties & Responsibilities:
• Model and detail implant and instrument designs utilizing Pro/Engineer design software.
• Utilize/Manage design controls and risk management tools.
• Interface with clinical advisors to gather input for design modifications and assessment of product risk. • Develop prototypes for design verification and validation.
• Develop verification and validation protocols and technical reports.
• Actively participate on, and sometimes lead, cross-functional design teams to address design issues and maintain existing designs.
• Partner with GQO teams in relations to Process Validation, Gauge Design & Inspection, Inspection Methodology and DFM.
• Utilize knowledge of the surgical procedure in order to develop innovative solutions to solve / satisfy customer needs.
• B.S. in Mechanical or Biomedical engineering or related engineering discipline required, advanced degree preferred.
• 4+ years of product design experience in medical device industry or other regulated industry.
• Expertise in the function, clinical issues and performance requirements of orthopedic implants.
• Expertise in design controls and risk management within a regulated industry.
• Expertise with a parametric CAD design package. Prefer Pro/Engineer. Expertise with Finite Element Analysis (FEA) and its application. Or expertise in other scientific or engineering discipline.
• Experience leading complex product development initiatives from cradle to grave.
• Demonstrated ability to effectively communicate engineering principals to all levels within the organization through oral and written means.
Percent Travel Required: Less than 5%