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Production Specialist



Silk Road Medical



Sunnyvale, CA, US


Summary: Performs various duties as related to the manufacturing, packaging and labeling of Silk Road Medical Products and Sub-Assemblies. Assists Production Management in scheduling and employee training and deployment.


  • Assist the Production department by completing assigned tasks which may include:
    • Creation and closure of production work orders in QAD system. May work with Finance to resolve issues as needed.
    • Assist with managing the lot assignment and completion for all production LHRs (Lot History Records).
    • Assist with coordinating the Production Schedule and daily Production Floor activities in compliance with cGMPs and ISO requirements.
    • Assist with managing the overall production build plan as assigned.
    • Coordinates efforts of various cross-functional groups to resolve Production Floor issues.
    • May serve as departmental representative with other departments for problem resolution and production reporting.
    • Ensures cross-training and process certification of employees are regularly implemented.
    • Participate in productivity projects as assigned.
    • Coordinates with Material Control to ensure components and consumable materials are available when needed.

Minimum Qualifications, Experience and Skills Required:

  • A minimum of 4 years of experience in a manufacturing/operations environment with a minimum of 1 year of leadership experience
  • Basic knowledge of computer applications such as MS Outlook, Excel, and Word.
  • Thorough knowledge of QAD transactions within production.
  • High school diploma or equivalent.
  • Previous work experience in medical device assembly and GMP environment is a must.
  • Knowledge of QSRs for Medical Devices.
  • Experience with material handling, material non-conformances, and Corrective Action Preventive Action preferred.
  • Knowledge of safety procedures used in preventing and addressing injuries

Other Essential Knowledge, Skills and Abilities:

  • Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other employees and supervisor.
  • Ability to read English and to comprehend verbal and written instructions.
  • Must be highly organized and able to execute tactics in a timely manner.
  • Effective verbal and written communication skills.
  • Experience with endovascular medical products and technologies preferred.
  • Knowledge of medical industry manufacturing techniques and equipment.
  • Working Environment:
    • Job duties are typically performed in a Cleanroom environment.  Overall duties require the ability to stand or sit for lengthy periods of time.  Walking or standing for extended periods of time within the Cleanroom, R&D Lab or warehouse areas may be required for the operation of equipment and assigned duties.  The noise level in the work environment is usually low to moderate.
  • Personal Protective Equipment:
    • The use of specialized equipment requiring additional training will be required.
    • The use of Personal Protective Equipment such as Latex/rubber/heat resistant gloves, UV eye protection, safety glasses, goggles, cleanroom gowning wear (smocks, head covers, beard covers, shoes covers) will be required.

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