Senior Engineer (Medical device remediation)
DivIHN Integration Inc
Medical device remediation-related project responsible for designing, developing, implementing, and evaluating optimal, cost-effective projects and technologies.
1. Must have experience or advanced training and demonstrate proficiency (e.g. Investigations, problem-solving, total quality management, statistical methods, DHF remediation, Risk file remediation, problem analysis and resolution, materials science, design of experiments, etc.)
2. Good understanding of MDR remediation; extensive cross-functional team experience, including technical and non-technical work.
3. Completely proficient in relevant products or process development processes.
4. Ability to organize and present technical and project management. overviews without assistance.
5. Act independently with minimal supervision to conduct smaller approved projects. Expected to make suggestions on improvements based on recent technical knowledge.
6. 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.
7. Ability to manage routine small projects without assistance.
8. Investigate and analyze customer service problems and design improvement suggestions. Recommend design improvements.
1) Knowledge of the basic principles in various engineering disciplines.
2) Must have initial training in concepts of
3) Must know how to effectively run projects, coordinate contractors, and direct the activities of a technician
BS in Engineering (discipline: Mechanical, Biomedical)
3-5 years of recent and relevant experience
Software: Word, Excel, Visio, PowerPoint, Outlook
Nice to haves: CAPA and Change control TW8 system experience
Preferences: good communication skills written and spoken
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
Design Control, DHF remediation, change controls, Product Risk filesApply