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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
