RS
Sr. R&D Engineer
Accepting applicationsRedBrick Staffing · Raleigh-Durham-Chapel Hill Area
Full-Time Mid_senior aiatementor
Posted
24 Apr
Category
Eda
Experience
Mid_senior
Country
United States
Job Responsibilities:
Lead product development initiatives from concept through commercialization – including design, prototyping, testing, & validation
Manage cross-functional teams to deliver projects on time & within budget
Develop clinically impactful & commercially viable systems/devices
Maintain project documentation, including DHF
Stay up to date with industry trends, competitors, & emerging technologies
Ensure regulatory compliance & high-level of quality
Conduct GD&T analysis & design optimization
Lead & support product testing activities – including feasibility studies, ASTM testing, & validation protocols
Partner closely with various teams throughout the product lifecycle
Promote a culture of innovation within the R&D team
Provide leadership & mentorship to Jr. engineers
Job Requirements:
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or similar – Master’s or Ph.D. preferred
7+ years of proven mechanical design experience in the medical device industry
Proficient in CAD software (e.g., SolidWorks), finite element analysis, etc.
Strong understanding of FDA regulations, ISO 13485, and other regulatory bodies for med devices
ASTM Testing Experience – Kinematic and stress analysis of mechanical systems
Excellent verbal & written communication skills
Strong interpersonal skills
Ability to successfully work cross-functionally
Comfortable working in a fast-paced, dynamic environment
Familiarity with sheet metal forming, injection molding, machining, thermoforming of plastics, etc. strongly preferred
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Lead product development initiatives from concept through commercialization – including design, prototyping, testing, & validation
Manage cross-functional teams to deliver projects on time & within budget
Develop clinically impactful & commercially viable systems/devices
Maintain project documentation, including DHF
Stay up to date with industry trends, competitors, & emerging technologies
Ensure regulatory compliance & high-level of quality
Conduct GD&T analysis & design optimization
Lead & support product testing activities – including feasibility studies, ASTM testing, & validation protocols
Partner closely with various teams throughout the product lifecycle
Promote a culture of innovation within the R&D team
Provide leadership & mentorship to Jr. engineers
Job Requirements:
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or similar – Master’s or Ph.D. preferred
7+ years of proven mechanical design experience in the medical device industry
Proficient in CAD software (e.g., SolidWorks), finite element analysis, etc.
Strong understanding of FDA regulations, ISO 13485, and other regulatory bodies for med devices
ASTM Testing Experience – Kinematic and stress analysis of mechanical systems
Excellent verbal & written communication skills
Strong interpersonal skills
Ability to successfully work cross-functionally
Comfortable working in a fast-paced, dynamic environment
Familiarity with sheet metal forming, injection molding, machining, thermoforming of plastics, etc. strongly preferred
Show more Show less