What are the responsibilities and job description for the Mechanical Engineer position at Katalyst Healthcares & Life Sciences?
Company Description
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description
Essential Duties and Responsibilities:
- Good understanding of product lifecycle, BOM structuring, standardization, Change management process.
- Lead data collection for over 400 Class II product codes for FDA GUDID Submission in 2016
- Lead data collection for over 250 Class II-LS product codes for FDA GUDID Submission in 2015
- Must have good knowledge on Medical products labeling & its standards.
- Should have hands on experience in UDI & GUDID.
- Create and review procedures (SOPs) for data collection, review, updates, change control, training documents, and discontinuation
- Collaborate on creating and maintaining project plans, deliverables, PLM data, status reports, and other project related activities
- Manage the day-to-day activities for a total of 4 engineers to complete project deliverables
- Good in documentation process, engineering documentation and specification standardization.
- Strong analytical skills with the ability to collect, organize, analyze Design related data from varies specification documents.
- Ability to understand large structured and unstructured data with attention to Design parameters from various products.
- Demonstrated superior communication (written and verbal), teamwork, and organizational skills.
- Experience in PLM tools – ERP, Teamcenter, SAP and any other PLM Tools.
- Excellent skills in MS Office (Word, Excel & PowerPoint) and MS Access tool.
- Highly proficient in configuration management.
- Maintain and own internal documents.
- Write, revise and review SOP's
Additional Information
All your information will be kept confidential according to EEO guidelines.
