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Manufacturing Engineer – Cer

Manufacturing Engineer – Cer

CompanyPROCEPT BioRobotics
LocationSan Jose, CA, USA
Salary$95000 – $120000
TypeFull-Time
DegreesBachelor’s
Experience LevelJunior, Mid Level

Requirements

  • Bachelor’s degree in Mechanical or Electrical Engineering, or an equivalent combination of experience and training.
  • Up to four years of relevant engineering experience.
  • Basic working knowledge of CAD (SolidWorks or similar) software.
  • Proficiency in Microsoft Office Suite and SolidWorks.

Responsibilities

  • Provide engineering support, with guidance from Senior Engineers or a manager, to address low-to-medium complexity issues on both the in-house and contract manufacturing (CM) floors, helping resolve production-impacting issues.
  • Support projects that involve collaborating with R&D and Process Development teams to transfer product and process changes into commercial manufacturing, both in-house and at the CM.
  • Under supervision, execute continuous improvement projects aimed at enhancing yield, consistency, performance, and capacity of processes.
  • Define, write, and update process limits, process instructions, BOMs, and LHRs/work orders.
  • Design, build, or procure less complex fixtures, tooling, or equipment to improve quality, reliability, and yield.
  • Ensure the controlled environment room is maintained and safe, providing a suitable work environment for assembly operations and supporting clean room activities.
  • With guidance from Senior Engineers, develop test protocols and perform tests to characterize new or existing equipment and processes, then write completion reports.
  • Under supervision, create process validation protocols, conduct verifications and validations for less complex processes, and generate the corresponding reports.
  • Assist with performing IQ, OQ, and PQ protocols when introducing new or changing existing manufacturing equipment.
  • Provide training or work direction to operators and technicians.
  • Travel up to 20% may be required, both domestically and internationally.

Preferred Qualifications

  • Experience in a medical device manufacturing environment.
  • Understanding of process validation (IQ, OQ, PQ) methodologies.
  • Experience working in or supporting cleanroom operations.