Batesville Batesville, IN 47006
Job Title: Project Engineer
Location: Batesville, IN - 47006
Duration: 6+ Months Contract
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
- Review company Technical files, labelling, and perform GAP analysis and Create STED to comply with MDR regulation.
- Perform mechanical, Bio compatible, sterility, packing, biomechanical, and animal testing for the products / Disposables of Class I, class IIa, IIb and Class III.
- Verification and validation summary.
- Risk assessment of medical devices.
- To be worked on Medical Devices (Class I, IIa, IIb & III). ISO 14971 – Medical Devices – Application of Risk Management to Medical Devices. ISO 13485 – Medical devices -- Quality management systems -- Requirements for regulatory purposes. Regulatory requirements MDD 93/42/EEC/ New MDR regulations & US FDA 21 CFR 820. ISO 10993-Biological Evaluation.
- To be worked on Electro mechanical devices. Good Understanding on Manufacturing Process Evaluate existing design features and define the functional design requirements that meet customer needs
- Medical Devices (Class I, IIa, IIb & III)
- ISO 14971 – Medical Devices – Application of Risk Management to Medical Devices.
- 13485 – Medical devices -- Quality management systems -- Requirements for regulatory purposes.
- ISO 10993-Biological Evaluation.
- new product development lifecycle.
- Design & Development of Electro Mechanical Products/Modules which includes verification and validation.
- Product knowledge and experience on Electro mechanical devices
- Understanding on Manufacturing process
- existing design features and define the functional design requirements that meet customer needs
- Writing Design Verification protocols and test reports with good documentation practices
- experience in FMEA, G D&T with Tolerance stack up analysis and Design documentation processes.
- experience in DFMEA and DFM. Expertise in all kind of manufacturing processes.
- Agile - PLM
Key Words: ISO 13485, ISO 14971, ISO 10993, MDR regulations, Techfile remediation, DHF remediation, Labelling & packaging for medical devices, QA/RA engineer
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
Vincent Gandra @ firstname.lastname@example.org ; Direct: 415-200-4129, Mobile:628-243-5231