Sr Manufacturing Engineer
at Katalyst Healthcares Life Sciences
Woburn, MA 01801, USA -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 08 Jul, 2024 | Not Specified | 09 Apr, 2024 | 5 year(s) or above | Production Lines,Iso,Maintenance,Manufacturing Processes | No | No |
Required Visa Status:
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US Citizen | Student Visa |
H1B | CPT |
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Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
Responsibilities:
- 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).
REQUIREMENTS:
- 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.
Responsibilities:
- 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)
REQUIREMENT SUMMARY
Min:5.0Max:6.0 year(s)
Mechanical or Industrial Engineering
Engineering Design / R&D
Mechanical Engineering
Graduate
Proficient
1
Woburn, MA 01801, USA