Senior Design Project Engineer

Job Responsibilities:

• Identify user needs & develop concepts
• Create mfg. drawings & instrumentation designs
• Design & develop implants & instruments
• Lead the development of new products from cradle to grave
• Contribute as member of project teams
• Develop, test, & validate prototypes
• Ensure products meet regulatory compliance
• Complete V&V activities
• Perform design control documentation for the project DHF
• Develop QC procedures & inspection methods
• Perform design change orders (COs)
• Provides technical input to various teams (e.g. Sales, Marketing, Regulatory Affairs, etc.)
• Support FDA submissions
• Support product launches

Job Requirements:

• Bachelor’s degree in Mechanical, Biomedical, Bioengineering, or similar
• 5+ years of relevant design & project management experience in medical device industry (implantables preferred)
• Experience with SolidWorks preferred
• Strong verbal & written communication skills