Staff Engineer

Stryker Corporation; Polska; On-site; Confidential; Full time

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

* Lead the design and implementation of new processes and technologies, from initial concept to production handover.* Conduct vendor assessments to select the best partners and technologies.* Work closely with vendors to ensure optimal process outcomes.* Serve as the local process expert, ensuring product and process quality meets or exceeds specifications.* Apply structured problem-solving to continuously improve process performance.* Lead machine qualifications and all related validation activities.* Coordinate the creation of all essential work instructions, SOPs, and process documentation including pFMEA, control plans, SPC, and MSA studies.* Drive process validation and documentation with precision and compliance.* Train and mentor engineers, technicians, and operators, fostering a process development mindset across the team.Develop comprehensive URS (User Requirements Specifications) in collaboration with stakeholders. * 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.* Developer mindset: always looking for ways to improve processes* Very good English communication skills.Experience in MedTech, pharma, food, or other regulated GMP environments. Familiarity with NC/CAPA initiatives and engineering change processes.