- Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures.
- Ensure quality of process and product as defined in the appropriate operation and material specifications.
- Assist in the selection of components and equipment based on analysis of specifications, reliability, and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.
- Participate in DTAP, PFMEA, Control Plan, SOP and PPAP generation associated with Design transfers and launches.
- Conduct MSA studies for new products and new processes at supplier site.
- Ensure adherence to GMP and safety procedures as applicable in industry.
- Good knowledge of computer applications, MSP and excellent presentation skills.
- Works on problems in limited scope; purposefully learns while gaining experience.
- Contributes to the project as a team member and handle supplier process development.
- Interpret customer needs and understands design inputs.
- Understand the product s intended use and clinical procedures.
- Understand and follow fundamental industry standards, design requirements and test strategies which align with regulatory requirements.
- With supervision, create or refine engineering documentation, such as the Design History file, Participate in V&V activates.
- Assist with prototyping and bench testing.
Education / Work Experience:
- Bachelor of Science in Engineering, Mechanical Engineering, BioMedical or Masters in related discipline
- 2+ years of work experience
- Fundamental knowledge and understanding of mechanical engineering practices and design principles for the process like Welding, Passivation, Laser Marking, Cutting, Bending, sheet metal etc.
- Basic knowledge of design and concept generation utilizing CAD and CAE tools.
- Basic knowledge of materials and manufacturing methods.
- Ability to read and Interpret complex drawings
- Basic knowledge of analysis tools and statistical methods.
Knowledge / Competencies:
- Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
- Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- Curious learners. Engineers who seek out cutting-edge research and information to expand and enhance their ability to develop software.
- Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
- Motivated product launchers. Engineers who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
