Staff Engineer - Validation
Join Our Team as Validation Engineer – Product Transfer at Stryker’s New Greenfield Manufacturing Site if you are passionate about ensuring that medical devices meet the highest standards of safety and quality. Do you thrive in dynamic environments and enjoy working as part of a team to bring innovative products to life? Stryker, a global leader in medical technology, is looking for a skilled and detail-oriented Validation Engineer to join our Product Transfer team at our new greenfield manufacturing site.
As a Validation Engineer on our Product Transfer team, you will play a critical role in ensuring that our medical devices and equipment not only meet but exceed all regulatory standards. You’ll work closely with process engineers, quality assurance, and validation representatives to ensure that every aspect of the product transfer process is compliant, optimized, and documented to the highest standards.
Key Responsibilities:
Collaborative Compliance: Work closely with cross-functional teams to ensure all aspects of product transfer are compliant with regulatory requirements and optimized for performance.
Specification and Procurement Support: Develop User Requirements Specifications and support device procurement, development, and commissioning stages.
Validation Expertise: Create and manage FAT, SAT, IQ, OQ, OQ-P, EQ, and PQ entities within the Val-G database, ensuring all validation processes are meticulously documented.
Process Consistency: Ensure that manufacturing processes lead to consistent and reproducible results, meeting both company and regulatory standards.
System Evaluation: Evaluate systems and processes used in product manufacturing, running tests, analyzing data, and documenting results to ensure they meet Stryker’s rigorous standards.
Protocol Management: Initiate and maintain protocol approval sessions with Validation Representatives, supporting the Product Transfer Process engineering team in MSA and Capability study protocols.
Validation Leadership: Act as the Subject Matter Expert in equipment and process validation, representing Product Transfer Engineering in ISO 13485 compliance matters.
Qualifications and Skills:
Educational Background: Bachelor’s degree in Quality, Biochemistry, Mechanical, Chemical, Materials, or Automation Engineering.
Practical Experience: Hands-on experience with validation processes, including equipment qualification, performance qualification, and process qualification.
Regulatory Knowledge: Familiarity with FDA, ISO, GMP standards, and quality assurance methodologies.
Analytical Skills: Strong problem-solving abilities to troubleshoot and optimize validation processes.
Attention to Detail: High level of precision in documenting validation processes and results, with a strong documentation bias to manage the entire validation process.
Teamwork: Enthusiasm for collaborative work with excellent verbal and listening skills to effectively share information within the team.
Technical Proficiency: Good computer skills and a structured approach to work, ensuring accuracy in documentation and communication.
"Right First Time" Mentality: Commitment to quality and accuracy, understanding that your work has a direct impact on patient health.
Additional Skills: Experience with Six Sigma, Cp, Cpk, and MSA practices is an advantage.
Language Skills: Proficient in Polish and English.
Why Join Us?
At Stryker, you’ll be part of a team that’s not just building products but transforming lives. This is your opportunity to contribute to a state-of-the-art manufacturing site, working alongside some of the best minds in the industry. If you’re ready to take on the challenge and make a real impact, apply now and join us in making healthcare better.
