Support manufacturing of products for medical devices with work including writing or verifying specifications; maintaining product process; designing fixtures; and testing process, equipment, and raw materials to ensure that the subassemblies and finished products meet their requirements. Work closely with R&D, Quality, and Regulatory in supporting the development of new products and manufacturing processes to achieve a smooth, successful transfer to Manufacturing Engineering and production laun... more details
Support manufacturing of products for medical devices with work including writing or verifying specifications; maintaining product process; designing fixtures; and testing process, equipment, and raw materials to ensure that the subassemblies and finished products meet their requirements. Work closely with R&D, Quality, and Regulatory in supporting the development of new products and manufacturing processes to achieve a smooth, successful transfer to Manufacturing Engineering and production launch. Job duties:
Support new and existing manufacturing processes, new products, product changes and enhancements, as well as related tooling and fixtures.
Draft and execute validation of product, equipment, and processes.
Provide mechanical design concepts for new equipment and fixturing to improve manufacturing process capability, capacity, efficiency, cost, and quality.
Lead builds for new product development in prototype and pilot production setting, including training of operators and coordination with production planning.
Confer with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems, and develop processes.
Lead projects related to process validation and product transfer activities across different manufacturing facilities and product lines.
A minimum of two (2) years of relevant medical device and manufacturing process development experience.
Demonstrated expertise with inferential statistical process analysis techniques.
Demonstrated expertise with mechanical design methods using SolidWorks.
Strong written and verbal communication skills, organizational skills, and ability to work in a fast-paced, self-directed environment.
Proficient with MS Word, Excel, Teams, and Outlook.
Desired Qualifications
Experience in Process Validations in medical device manufacturing environment.
Experience in statistical process analysis tools, including Design of Experiments (DOE) and Cpk for process development characterization and optimization.
Solid proficiency in technical documentation, including advanced CAD modeling and engineering drawings.
Demonstrated expertise related to mechanical design of manufacturing equipment, fixturing, and tooling.
Working knowledge of conventional and CNC machining processes.
Job Abstracts is an independent Job Search Engine. Job Abstracts is not an agent or representative and is not endorsed, sponsored or affiliated with any employer. Job Abstracts uses proprietary technology to keep the availability and accuracy of its job listings and their details. All trademarks, service marks, logos, domain names, and job descriptions are the property of their respective holder. Job Abstracts does not have its members apply for a job on the jobabstracts.com website. Additionally, Job Abstracts may provide a list of third-party job listings that may not be affiliated with any employer. Please make sure you understand and agree to the website's Terms & Conditions and Privacy Policies you are applying on as they may differ from ours and are not in our control.
Any time you conduct a search, the system shows you job matches, ranked by their Relevance Score (RS).
The score is calculated by a proprietary algorithm that uses Intelligent Machine Learning.
The Relevance Score tells you how well the job opportunity matches your search term or terms.
When not logged in, the system is limited to one search term. Scores for single term matches are usually lower.
When you register, log in, and set up multiple terms prioritized by importance, the jobs found for you will receive a much higher Relevance Score.