Milwaukee Milwaukee, WI 53215
Job Title: Mechanical lead
Location: Milwaukee, WI - 53215
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
- Handle two client plants and Guidance to both the teams on the all activities of MDR-Tech file remediation
- Project plan and Estimation preparation along with Offshore Lead
- Product understanding and responsible for providing the training to offshore
- Provide the spontaneous clarifications on team/client queries
- Providing the input documents to the Offshore team
- Follow-up of all team action items /process
- Responsible for the on time onsite document deliverables
- Review/Walkthrough of all deliverables before sharing with client, if found mistakes providing clear redlines to offshore
- Attending all deliverables review meetings with client, full responsibility.
- Updating review comments received from client if it is less than 20%
- Complete execution of one eSTED in addition to all activities (any one project ex: Dr Fog), once done next product to be owned.
- Preparation and presentation of weekly status to client with offshore manager concurrence
- Should Attend all Technical huddles, SMRs and Corporate Level Meetings
- Weekly Learning’s KT session to offshore team
- In-depth understands on Medical Devices (Class I, IIa, IIb & III).
- Knowledge on ISO 14971 – Medical Devices – Application of Risk Management to Medical Devices.
- Knowledge on ISO 13485 – Medical devices -- Quality management systems -- Requirements for regulatory purposes.
- Knowledge on regulatory requirements MDD 93/42/EEC/ New MDR regulations & US FDA 21 CFR 820.
- Knowledge on ISO 10993-Biological Evaluation.
- Basic knowledge on biomaterials (Metals, Polymers, Ceramics, Material Characterization techniques).
- Good Clinical Practices (GCP) & Good laboratory practices.
- Knowledge on new product development lifecycle.
- Hands on experience in Design & Development of Electro Mechanical Products/Modules which includes verification and validation.
- Good Product knowledge and experience on Electro mechanical devices
- Good Understanding on Manufacturing process
- Evaluate existing design features and define the functional design requirements that meet customer needs
- Writing Design Verification protocols and test reports with good documentation practices
- General knowledge on various Medical devices.
- Hand on experience in FMEA, G D&T with Tolerance stack up analysis and Design documentation processes.
- Hands on experience in DFMEA and DFM. Expertise in all kind of manufacturing processes.
- Good written and verbal communication skill and should be capable of handling the project with minimum assistance.
- Responsible for drafting, reviewing, and strategizing US, EU and international regulatory submissions
- Preparation of Technical Files.
- 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.
- Execute Verification and validation summary.
- execute Risk assessment of medical devices.
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 - 415-200-4129