Work Flexibility: Onsite
What you will do
Support Manufacturing/Operations for the Surgical Stryker Sustainability Solutions Business during Transfer and Post-Launch activities, concentrating on a specific project to ensure business stability.
Responsibilities for this project role include:
- Evaluating manufacturing outcomes and implementing continuous improvements and cost efficiencies, supporting New Product Introductions (NPI) and new equipment/process introductions, increasing capacity, reducing scrap, improving yield, enhancing safety, monitoring existing processes, and identifying and implementing process improvements within a regulated medical device reprocessing environment.
- Apply Statistical, Lean, GMP, and Six Sigma methodologies to support and improve existing processes, ensuring they align with the project’s scope and objectives.
- Manage the effective transfer of new products, design changes, or line-extended devices to production, focusing on Transfer and Post-Launch activities.
- Foster a culture of continuous improvement by collaborating with cross-functional teams and providing project-specific support across all functional areas.
- Conduct Failure Analyses (FAs) and implement enhancements to improve the functionality, performance, and reliability of medical devices.
- Optimize manufacturing processes by implementing process improvements, reducing scrap rates, enhancing machining operations, and ensuring compliance with safety standards.
- Develop and execute technical protocols, generate comprehensive reports documenting project milestones, and implement clear operating procedures, including standard work and visual work instructions.
- Train production staff on new product launches and design changes, ensuring smooth transitions and alignment with project requirements.
- Gain and apply in-depth knowledge of FDA/ISO standards, including Design Control, to ensure compliance and support the successful execution of medical device projects.
What you need
- B.S. in Engineering (Industrial, Mechanical, Electrical or related).
- Minimum 2 years of experience as Manufacturing Engineer in a highly regulated industry, preferably in a Medical Devices company.
- Experience with development of protocols for process validation.
- Knowledge of One PLM, Valgenesis and SAP systems is a plus.
- Knowledge of AutoCAD is desirable.
- Basic computer skills (word processing, spreadsheets, database).
- Conversational English.
- Problem solving skills.
- Availability to work on a 14 months contract.
Travel Percentage: 20%