Work Flexibility: Onsite Initial 23 month FTC Position Summary The Senior Project Engineer will provide technical leadership across various project related activities. A knowledge of the design, development, and validation of manufacturing technologies essential for the role. This role will focus particularly on supporting the project team in validation and SOP documentation preparation as well as change control requests. What you will do Provide engineering support for new equipment and process changes, ensuring that all activities are completed and documented in accordance with regulatory requirements. Write and edit standard operating procedures, test methods, technical/validation reports, regulatory submissions, investigations, and other related documents (VP, IQ, OQ, URS, etc.) Evaluate process layouts in terms of supporting new process integration while ensuring best utilisation of floor space ensuring optimum process flow. Support budgetary, scheduling, and project databases, and report regularly to project manager on progress as well as on problems that could significantly affect cost or schedule. Development of appropriate supporting documentation, SOPs, PFMEA, Control Plans and process work instructions compliant with current Good Manufacturing Practices (GMP). Transferring and implementing processes, either from development, or from another manufacturing facility. Partner with technical leadership and cross-functional partners such as Manufacturing, Quality, Process Development, Validation, and Facilities to implement appropriate written documentation. Work with initiators to rewrite, clarify, or reconstruct controlled documents and investigations. Developing specifications in the form of a URS for new equipment purchases. Conduct MSA studies for products and new processes. Responsibility as technical lead for projects (value stream and cross functional) as assigned by the company, including the scoping, approval, budgeting, specification, execution, qualification and operational handover as appropriate. Observing the Quality Management Systems requirements on site at all times All other duties as assigned. What you will need Level 8 Degree in Mechanical Engineering or equivalent technical experience is required. Proven Project Engineering skills through the delivery of business critical projects or equivalent. Minimum 2 years’ experience in a GxP manufacturing environment. Strong communication and influencing skills with both internal and external agents. Capable of working as part of a multi-disciplined team in an aggressive, dynamic and results motivated environment. Demonstrable analytical problem-solving skills, a process improvement orientation, and the ability to handle multiple tasks in a fast-paced and results-oriented environment. Travel Percentage: 10% Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.