Staff Engineer, New Process Development

Stryker; Skawina; On-site; PLN 124,000 - 207,000; Full time

Job summary

Stryker is seeking a Process Engineer for our new Skawina cleanroom site (ISO7). You will lead projects around cleaning implants and instruments, install cleaning equipment, and provide technical leadership in manufacturing operations.

You will develop process documentation, PFMEA and control plans, and ensure MES/SAP integration. A Master’s in engineering and 4+ years in serial production (MedTech/Automotive) with GMP exposure and strong English is required.

Qualifications

• Master's degree in industrial engineering, chemical engineering, or similar.
• 4+ years of experience in serial production industries, preferably in MedTech or Automotive sectors.
• Experience in cleanroom environments is a plus.
• Proficiency in PFMEA, SPC, MSA, and DoE.
• Familiarity with Vision Systems, Robot programming, and advanced measuring systems.
• Excellent PC skills and proficiency in English communication.
• Experience in process validation and automation is highly desirable.
• Previous experience in regulated environments based on GMP standards is advantageous.

Responsibilities

• Lead significant engineering projects, including cleaning of implants and instruments: you will be responsible for implementing and installation of cleaning equipment in the cleanroom environment
• Provide technical leadership and operational support for manufacturing operations in our cleanroom environment, including equipment validation and cleanroom process-flows.
• Serve as a local process expert in cleaning processes
• Collaborate with multifunctional teams on technology development and application.
• Manage the selection and qualification of machine manufacturers and suppliers.
• Develop comprehensive work instructions, procedures, and documentation.
• Lead the development of PFMEA, Control Plans, and process validation procedures.
• Integrate new processes with MES/SAP systems.
• Train and mentor operators and engineers to ensure process excellence.

Skills

PFMEA

SPC

MSA

DoE

Robot programming

Vision Systems

Automation

English communication

Education

Master's degree in industrial engineering or related field

Tools

MES

SAP

GMP tools

Job description

Are you ready to drive innovation in a cutting-edge cleanroom (ISO7) environment? Stryker, a leading MedTech company, is seeking an experienced Process Engineer to join our cleanroom team at our new manufacturing site in Skawina. We specialize in final cleaning and packaging of titanium and stainless-steel implants and instruments. Join us to work in an environment where your ideas are valued, and your contributions make a real impact on patient care worldwide. Join us in shaping the future of healthcare!

What will you do?

• Lead significant engineering projects, including cleaning of implants and instruments: you will be responsible for implementing and installation of cleaning equipment in the cleanroom environment
• Provide technical leadership and operational support for manufacturing operations in our cleanroom environment, including equipment validation and cleanroom process-flows.
• Serve as a local process expert in cleaning processes
• Collaborate with multifunctional teams on technology development and application.
• Manage the selection and qualification of machine manufacturers and suppliers.
• Develop comprehensive work instructions, procedures, and documentation.
• Lead the development of PFMEA, Control Plans, and process validation procedures.
• Integrate new processes with MES/SAP systems.
• Train and mentor operators and engineers to ensure process excellence.

What do you need?

• Master\'s degree in industrial engineering, chemical engineering, or similar field.
• 4+ years of experience in serial production industries, preferably in MedTech or Automotive sectors.
• Experience in cleanroom environments is a plus.
• Proficiency in analytical tools such as PFMEA, SPC, MSA, and DoE.
• Familiarity with Vision Systems, Robot programming, and advanced measuring systems.
• Excellent PC skills and proficiency in English communication.
• Experience in process validation and automation is highly desirable.
• Previous experience in regulated environments based on GMP standards is advantageous.
• Knowledge of NC/CAPA initiatives and engineering changes is a bonus.

Poland Pay Ranges:

• Poland, Skawina: zł124.000 - zł206.700 PLN Annual

At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package.

If you’d like to learn more about the salary or the benefits associated with this role, your recruiter will be happy to walk you through the details as you progress through the hiring process.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.