Manufacturing Engineers-6 month contract-Medical Device-Santa Clara, Ca 20% Remote!
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.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
- 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 firstname.lastname@example.org