As a Manufacturing Engineer at Stryker Robotics, you will play an essential role in sustaining and improving the manufacturing processes of our advanced surgical robotic systems. You will support product quality, process reliability, and operational efficiency while ensuring compliance with Stryker’s Quality Management System and regulatory requirements.
Ensure the quality of manufacturing processes and products by adhering to operational specifications and material requirements by managing nonconforming material occurrences.
Participate in the creation and maintenance of PFMEAs, Control Plans, Standard Operating Procedures (SOPs), and Production Part Approval Process (PPAP) documentation to support product transfers and manufacturing scale-ups.
Develop and implement supporting documentation, including work instructions and process SOPs, in alignment with current Good Manufacturing Practices (GMP).
Provide hands-on technical support for troubleshooting manufacturing process and product issues within assigned value streams.
Deliver training to manufacturing team members to enhance process understanding, quality awareness, and operational excellence.
Communicate effectively and collaborate with cross-functional teams and external partners to support system and process troubleshooting activities.
Lead and participate in cross-functional and cross-divisional process improvement initiatives aimed at enhancing productivity, quality, and cost efficiency.
Support process and product validation activities, including Validation Plans (VP), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) along with associated documentation.
Conduct Measurement System Analysis (MSA) including Gage R&R studies for new processes and products.
Apply structured problem-solving methodologies to identify root causes and implement corrective actions for NC/CAPA investigations.
Utilize and develop statistical tools to support data-driven decision making and continuous improvement initiatives.
Support capital acquisition projects from equipment specification and supplier engagement to installation, validation, and production readiness.
Minimum Requirements:
Bachelor’s degree in Engineering (Mechanical, Industrial, Biomedical, Electrical, Robotics, or Manufacturing).
0+ years of experience in manufacturing, engineering, or related technical field, preferably in a regulated industry.
Preferred Skills:
Familiarity with FDA QSR, ISO 13485, and risk-based validation strategies.
Experience in manufacturing process development, troubleshooting, and continuous improvement.
Knowledge of process validation (IQ/OQ/PQ) and measurement system analysis (Gage R&R).
Proficiency in problem-solving methodologies (e.g., Root Cause Analysis, 5 Whys, Fishbone).
Strong communication and collaboration skills to work effectively across teams.
Proficiency in statistical analysis tools such as Minitab or equivalent.
Passion for digitalization: PowerBI
Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.