5 Jobs in Woburn, MA
Katalyst Healthcares & Life Sciences is Hiring a Sr Manufacturing Engineer Near Woburn, MA
- Develop and execute required validations in line with regulatory requirements to include Equipment, Process & Product validations.
- Develop Specification, Procurement, Installation, and Validation of Manufacturing Equipment, including on site Factory Acceptance Testing of equipment.
- Provide ongoing day to day support to Production; continually seek to drive improvement in operation performance while also maintaining highest levels of regulatory conformance.
- Establish and maintain appropriate Manufacturing documentation including, Equipment documentation, pFMEAs, TMVs, Bills of Materials, Part Numbers, Product routings, Manufacturing procedures and Logs.
- Drive SAT (Site Acceptance Test) for Mfg. equipment necessary for internal/external Mfg. process in which client owns the product/process design.
- Partner with R&D, Quality, Regulatory Affairs and Operations to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective.
- Analyse product designs for best method of manufacture.
- Work collaboratively in the design, development, and/or improvement of manufacturing processes and equipment.
- Ensure that manufacturing has accurate and detailed information on specifications, with customer manufacturer under corresponding QMS (Quality Management System).
- BSME with 5 years or MSME with 6 years mechanical design/engineering experience or equivalent combination of education and experience.
- Experience on Process validation protocols and reports (IOQ/PQ) from manual to automated production lines.
- Experience with FDA, ISO, and IEC standards a plus.
- Experience with vascular products a plus.
- Strong technical understanding of set up and maintenance of manufacturing processes.
- Has supported medical device relocation efforts.
- Strong problem-solving capabilities through tools and techniques to implement systematic solutions internal/external processes.
Job Summary
Contractor
$114k-135k (estimate)
06/04/2024
07/28/2024
katalysthls.com
South Plainfield, NJ
<25
Related Companies
The job skills required for Sr Manufacturing Engineer include Manufacturing Processes, Problem Solving, ISO, Manufacturing Equipment, etc. Having related job skills and expertise will give you an advantage when applying to be a Sr Manufacturing Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Sr Manufacturing Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Sr Manufacturing Engineer positions, which can be used as a reference in future career path planning. As a Sr Manufacturing Engineer, it can be promoted into senior positions as an Industrial Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Sr Manufacturing Engineer. You can explore the career advancement for a Sr Manufacturing Engineer below and select your interested title to get hiring information.
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