Staff Engineer, New Process Development
Stryker Ireland, Ltd.
Apply to this jobAre 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.
Summary
Lead cleaning process projects, develop procedures, validate processes, mentor staff in a cleanroom environment.
Job title
Staff Engineer, New Process Development
Experience level
4+ years
Minimum experience
4+ years exp
Industry
medical technology
Location requirements
Hybrid or onsite in Skawina, Poland; remote not allowed.
Salary
Not specified
Visa sponsorship
H-1B sponsor history
Management role
No
Required skills
Preferred skills
Specializations
Structured locations inferred from the posting.
Skawina, Poland