As a Sr. Manufacturing Engineer, this individual is responsible for maintaining and scaling existing production lines including resolving line down scenarios and identifying and implementing continuous process improvements. The position will be responsible for on-demand production line support, define manufacturing driven metrics (cycle times, capacity, bottlenecks etc.), design, duplicate and/or deploy manufacturing fixture and tooling, develop and train on manufacturing processes and perform equipment qualification and process validation activities.
Core Job Responsibilities:
- Provide daily support to troubleshoot and resolve manufacturing production issues following GMP and company Quality Management System.
- Identify root cause of operational failures and support Corrective and Preventative Action plans by provide solutions using problem-solving skills including Fishbone, 5 Whys or Pareto Charts.
- Define and implement continuous process improvements to existing manufacturing operations including process verification, MFG documentation updates and process validation.
- Design, document, assemble, qualify and release custom and off the shelf manufacturing and testing tooling, fixtures and equipment. Create and release associated maintenance and calibration procedures.
- Perform routine equipment preventative maintenance and/or repair and serve as manufacturing liaison for external calibration activities.
- Author and execute manufacturing documentation, including protocols, reports, manufacturing process instructions, standard operating procedures and equipment/fixture specifications.
- Generate production metrics including yields, scrap rates, capacity/bottle necks and cycle times and routinely present to management.
- Other manufacturing engineering duties or support as assigned or requested.
Required Knowledge/Skills, Education, And Experience:
- S degree in Chemical, Mechanical, Biomedical Engineering or
- 5+ years experience as design or manufacturing engineer supporting product development or production lines. 3+ years with an advanced degree.
- Experience with GMP/GDP is required
- Experience with manufacturing equipment design and development is required
- Experience with process validation planning/execution, IQ/OQ/PQ protocols and reports.
- Understanding of statistical methods is required
- Solidworks Experience is required
- Proficient with standard business software (MS Office, Excel, Outlook etc.)
- Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820.
Preferred Knowledge/Skills, Education, And Experience:
- Experience with sterility assurance is preferred
- Prior experience in medical device or other highly regulated industry is preferred.
- Agile PLM experience is preferred
- Understanding of engineered materials and fabrication methods is preferred
- Experience with reprocessing and sterilization of reusable medical devices, especially those with long lumens, is preferred