Sr. Manufacturing Engineer-Contract-Medical Device-Santa Clara, CA
The Manufacturing Engineer is responsible for new product introduction 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.
- 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.
- This role requires the use of varying levels of personal protective equipment (including, gowns, masks/face shields, gloves, and safety glasses).
- This role routinely uses standard office equipment such as computers, phones, and photocopiers.
- Must be able to lift a minimum of 25 pounds and perform repetitive bending and lifting motions over a period of time.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- The employee frequently is required to stand, walk; use hands to finger, handle or feel; and reach with hands and arms.
- Bachelor’ Degree in Engineering: Manufacturing, Industrial, Mechanical, Biomedical or related field and 3 years experience as design or manufacturing engineer supporting product development or production lines.
- Master’s Degree Engineering: Manufacturing, Industrial, Mechanical, Biomedical or related field and 1 years experience as design or manufacturing engineer supporting product development or production lines
- Experience with GMP/GDP
- Experience with manufacturing equipment design and development
- Experience with process validation planning/execution, IQ/OQ/PQ protocols and reports.
- Understanding of statistical methods
- SolidWorks Experience
- Proficient with standard business software (MS Office, Excel, Outlook etc.)
- Prior experience in medical device, working in regulated environment in compliance to ISO 13485 and 21 CFR 820.
- This is a full-time position – First shift days and hours of work are flexible
- Occasional evening and weekend work may be required as job duties demand.
- Ability to travel (10%) to and from headquarters in Santa Clara, CA.
- Advanced Degree
- Agile PLM experience
- CAMSTAR experience
- Understanding of engineered materials and fabrication methods
- Experience with robotics or large capital equipment assembly
Please send resume to email@example.com