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Staff Engineer - Process Automation & GMP Validation

Stryker Corporation

Polska

On-site

Confidential

Full time

Yesterday
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Job summary

A leading medical technology company is looking for a Process Engineer in Poland to lead the design and implementation of innovative processes and technologies. You will collaborate with vendors, ensure quality and compliance in process performance, and train a team of professionals. The ideal candidate will hold a Master's degree in engineering, possess strong expertise in automation, and have experience in regulated environments such as MedTech or pharma. Excellent English communication skills are required for this role.

Qualifications

  • Master’s degree in mechanical, industrial engineering, or similar.
  • Proven experience implementing new processes, technologies, and production automation.
  • Expertise in automation of grinding, polishing, and forming processes is a plus.
  • Strong knowledge of PFMEA, SPC, MSA, DoE and other analytical tools.
  • Hands-on experience with vision systems and robot programming.
  • Very good English communication skills.
  • Experience in MedTech, pharma, food, or other regulated GMP environments.

Responsibilities

  • Lead the design and implementation of new processes and technologies.
  • Conduct vendor assessments to select partners and technologies.
  • Work closely with vendors to ensure optimal process outcomes.
  • Serve as the local process expert, ensuring quality meets specifications.
  • Apply structured problem-solving to improve performance.
  • Lead machine qualifications and related validation activities.
  • Coordinate the creation of work instructions, SOPs, and process documentation.
  • Drive process validation and documentation with precision.
  • Train and mentor engineers, technicians, and operators.
  • Develop comprehensive URS in collaboration with stakeholders.
Job description
A leading medical technology company is looking for a Process Engineer in Poland to lead the design and implementation of innovative processes and technologies. You will collaborate with vendors, ensure quality and compliance in process performance, and train a team of professionals. The ideal candidate will hold a Master's degree in engineering, possess strong expertise in automation, and have experience in regulated environments such as MedTech or pharma. Excellent English communication skills are required for this role.
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