Development Engineer – Medical Device

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Job ID#: 26893

Development Engineer – Medical Device
Direct Hire; up to 110K
Sugar Land

Duties:
 

• Develop new products following design control procedures from feasibility through product commercialization
• Create, maintain, and review documentation for Design History File (DHF)/Medical Device File (MDF), including Design Validation Plans/Reports, Test Protocols/Reports, User Needs, Design Input/Output Matrix, Risk Assessments, and Design Transfer in accordance with TSI QMS Procedures
• Perform hazard and risk analysis for new products, including dFMEAs, pFMEAs, and uFMEAs
• Identify tasks required to complete project assignments according to Design Control procedures
• Work with marketing and engineering to generate and/or contribute to the creation of prototype models to evaluate new design concepts
• Develop, revise, and/or review detailed engineering drawings
• Research and understand device functionality and intended clinical use
• Identify user needs and translate into product specifications
• Establish design goals and specifications based on requirements and user needs
• Conduct or participate in brainstorming and root cause analysis
• Provide technical review of regulatory submissions; participate in design reviews
• Review manufacturing process for manufacturability, quality requirements, design requirements, and state-of-the-art validations (IQ, OQ, PQ)
• Provide support of DHF reviews during internal, external, and customer audits
• Perform investigations for issues affecting product quality pre-launch

Qualifications:
 

• Bachelor of Science degree from an ABET accredited school (or global equivalent) in Mechanical or Biomedical Engineering or a related
• 3+ years’ engineering experience in the medical device industry
• 2+ years’ experience in medical device product development
• Technical writing, research paper writing, and/or experimental design experience
• Collaborative approach with cross-functional project team of design engineers, quality engineers, RA/QA, product managers, project manager, and sales

Other Info:
 

• Business casual attire
• Thriving and growing organization recently involved in acquisitions; 160 team members
• Well-rounded benefits package
• Amazing company culture – collaborative, fun, down to earth, engaging, and approachable and motivating senior leadership
• Reports to Director of Engineering and Product Development
• Some travel may be required

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