Design Control Engineer
Plainsboro Plainsboro, NJ 08536
Job Title: Design Control Engineer
Location: Plainsboro, NJ 08536
Duration: 6+ Months
About our Client : Our Client is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions – underpinned by the world’s largest delivery network – Our Client works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 425,000 people serving clients in more than 120 countries, Our Client drives innovation to improve the way the world works and lives
- Experience in working in Medical device - New product development & DHF Remediation projects
- Experience in performing Gap assessments for MDD 93/42 compliance requirements and creating remediation plans
- Experience in Technical file gap assessments and remediation planning and executions
- Experience in creating Design inputs / requirements, Design outputs, Design verification & Validation
- Good understanding of EUMDR 2017/745 regulatory requirements and assessments for medical devices
- Good understanding of ISO13485 & ISO14971 standards, 21 CFR Part 820 & EU MedDev Regulations
- Good understanding on product sterility, biocompatibility, labeling & packaging standards
- Experience in Risk Management plan, Hazard Analysis, DFMEA, PFMEA, Use FMEA, Software Hazard Analysis, Risk Management Report
- Experience in updating risk management files based on post market surveillance feedback like complaints
- Should have experience in direct interaction and co-ordination with stakeholders, customers and vendors.
- Proficient in Solidworks (Part design, Drawing, BOM creation, assembly drawing etc).
- Proficient in working with PLM tools like Agile / equivalent.
- Good written and verbal communication skill and should be capable of handling the project with minimum assistance
About ASK: ASK Staffing is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Staffing connects people with amazing opportunities
Jeff Kasula @ email@example.com ; - 415-200-4127