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.

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.
• 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.

Qualifications

• 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.

OR

• 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.

Preferred

• Advanced Degree
• Agile PLM experience
• CAMSTAR experience
• Understanding of engineered materials and fabrication methods
• Experience with robotics or large capital equipment assembly

Pay Rate-60-70/hr.

Please send resume to kjohnson@nelsoninteractive.net