Position: Principal Engineer, Product Quality Advanced Surgery
Contract to hire for the right candidate
Engineer will be responsible for developing new products used in surgical procedures, through partnerships with R&D and other cross functional team members. Strong understanding of Quality compliance i.e. building quality into products through design control and compliance with procedures. Engineer should be able to navigate with sustaining the products in the field in compliance with the quality system and technical expertise and have had hands on experience with product development and risk management activities.
1. Ensure compliance to procedures, especially Design Control and Risk Management with respect to development of new products. Active participant in the Core Team, applying engineering knowledge to move projects forward successfully.
2. Ensure compliance to Change Control procedures to make changes to currently marketed product.
3. Act independently as QA R&D product SME with minimal supervision to conduct smaller approved projects. Expected to make suggestion on improvements based on science & technical knowledge.
4. Contribute to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a larger project.
5. Manage routine small projects without assistance. Coordinates with cross functional team to set realistic timelines and set team for success.
6. Recommend design improvements via customer feedback investigation and analysis.
1) Knowledge of the basic principles in various engineering disciplines. Must have experience in product development demonstrating proficiency in Design control elements, problem solving, total quality management, statistical methods, DHF development, Risk file creation, problem analysis and resolution, materials science, design of experiments etc.
2) Must have initial training in concepts of
? quality techniques.
3) Completely proficient in relevant product development processes in compliance with FDA design control 21CFR820.3 and ISO13485
4) Good understanding of EUMDR desired; extensive cross-functional team experience, including technical and non-technical work.
BS in Engineering (discipline: Biomedical, Chemical &/or Mechanical)
At least 5-8 years of recent and relevant new medical device product development experiences, with proficiency and skills in DHF remediation and risk remediation.
Extensive medical device design controls experience.
Software: Word, Excel, Visio, PowerPoint, Outlook
Nice to haves: CAPA TW8 system experience, Trackwise8 proficiency
Good communication skills written and spoken and be able to participate in team meetings with conviction and confidence
Interview Platform: Video WebEx (2 to 3 rounds)
1. At least 5-8 years of recent and relevant new medical device product development experiences, with proficiency and skills in DHF remediation and risk remediation.
2. Extensive medical device design controls experience.
3. Good communication skills written and spoken and be able to participate in team meetings with conviction and confidence
4. Software: Word, Excel, Visio, PowerPoint, Outlook 5. BS in Engineering (discipline: Biomedical, Chemical &/or Mechanical)
6. Nice to haves: CAPA TW8 system experience, Trackwise8 proficiency
7. Job Longevity
8. Local Candidates