Who we want

Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
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.

Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

User-focused creators. People who imagine with the user in mind, developing technology that helps change patients’ lives.

What you will do

As a Staff Engineer, Design Assurance, you will partner with Product Development and Advanced Operations to define design requirements and develop manufacturing processes, respectively, for orthopedic surgical robotics product launches. Also lead risk-management activities in the new product development process to ensure the highest level of product and process quality.

Responsibilities:

• Partner with cross functional project teams to lead product and/or process design and development activities
• Lead Risk Management activities for high-volume orthopedic product launches
• Evaluate overall residual risk for products prior to launch and present final risk-benefit justification to executive leadership
• Present risks associated with the product use during Design Reviews and track how the design, documentation and manufacturing process mitigate risks linked to product
• Partner with Product Development to define design verification and validation test requirements that will ensure appropriate objective evidence is available to support the acceptance criteria
• Partner with Advanced Operations in the development of manufacturing processes for new products
• Develop, review and approve inspection plans, routers and product drawings
• Partner with Advanced Operations to define process and process controls and subsequently design transfer product to manufacturing
• Develop quality assurance documentation to support regulatory submissions
• Work with complaint investigators to complete post-market health risk assessments
• Lead quality system maintenance for the division by identifying and correcting deficiencies in our procedures and practices
• Manage, lead and/or assist in resolving nonconformities and corrective/preventive actions (CAPA)

What you need

Basic Qualifications:

• Bachelor’s Degree in Engineering.
• Minimum 5 years working in quality, engineering or new product development environment.

Preferred Qualifications:

• Bachelors Degree or Master’s degree in relevant field desired. 
• Medical Device or highly regulated industry experience desired.