Mechanical Design Engineer II

About the role

The hire will solve problems and implement innovative solutions within the Manufacturing Engineering group. This role creates designs and drawings for Engineering, Production, and Research and Development teams. The position develops new equipment and fixtures and their related processes specifically for medical devices and components. The hire will execute detailed root cause analysis and recommend vetted solutions to complex issues. They will communicate and explain problems and solutions cross-functionally and interdepartmentally to ensure alignment. The role requires approaching problems from a detail-oriented perspective to ensure precision. The hire will suggest independent recommendations for project approaches, scope, and tactics to drive improvement.

Key facts

What you'll do

• Investigate and resolve production issues by analyzing root causes and implementing effective solutions.
• Generate detailed engineering designs and technical drawings for use across Engineering, Production, and R&D departments.
• Develop new medical device manufacturing equipment and fixtures while defining associated process workflows.
• Conduct thorough root cause analysis to identify underlying issues and validate corrective actions.
• Translate complex technical problems into clear communication for cross-functional and interdepartmental stakeholders.
• Apply meticulous attention to detail to ensure designs and processes meet stringent quality standards.
• Formulate independent recommendations regarding project strategy, scope definition, and tactical execution.
• Provide production support by authoring and maintaining detailed technical documentation and work instructions.
• Monitor equipment performance metrics and identify opportunities for process improvements to boost yield and efficiency.
• Demonstrate comprehensive understanding of quality, operational, and financial systems and company product lines.
• Design, acquire, and implement fixtures while sourcing off-the-shelf tooling and equipment for production lines.
• Execute equipment qualifications and validation activities to ensure compliance and performance.
• Plan, schedule, conduct, and coordinate detailed engineering phases for projects or entire project portfolios.
• Develop detailed specifications for tooling, fixtures, and equipment to guide manufacturing processes.
• Coordinate with internal teams and external suppliers to facilitate improvements and resolve dependencies.
• Participate actively in project planning and scheduling to ensure timely delivery of engineering objectives.
• Train assemblers, quality control personnel, and technicians on processes, equipment, and documentation procedures.
• Perform other technical activities requiring knowledge of principles and techniques common to specific project areas.
• Adhere strictly to the Company's Quality Management System (QMS) and domestic and global quality regulations.
• Understand relevant security, privacy, and compliance principles and adhere to all applicable regulations and procedures.
• Ensure other department members follow QMS protocols, regulations, standards, and procedures consistently.
• Perform other work-related duties as assigned by management or project leads.

Requirements

• Possess a Bachelor's degree in Engineering or a related technical field with 1+ years of relevant engineering experience.
• Consider equivalent combinations of education and technical experience that demonstrate required competencies.
• Exhibit excellent written, verbal, and interpersonal communication skills in all professional interactions.
• Demonstrate proficiency in Word, Excel, PowerPoint, Access, and other common computer applications.
• Maintain a high degree of accuracy and attention to detail in all tasks and deliverables.
• Show excellent organizational skills with the ability to prioritize multiple assignments simultaneously.
• Adhere to ethical and security guidelines concerning sensitive company information.
• Collaborate effectively within diverse teams to achieve shared project goals.
• Follow established procedures and standards consistently without deviation.
• Commit to continuous learning and professional development in engineering practices.
• Respect company policies and regulatory requirements in all aspects of work.
• Apply critical thinking to evaluate processes and propose constructive improvements.
• Maintain professionalism and reliability in meeting deadlines and expectations.

Nice to have

• Engineering experience in a manufacturing environment is recommended for this role.
• Experience within the medical device industry is preferred for this position.
• Knowledge of FDA regulations, Lean/Flow Manufacturing principles, and materials and manufacturing processes is desired.

Practical notes

This is an external engagement based in Roseville, California. The role may require some on-site presence. Travel is not expected as part of this role. The position operates within standard business hours with flexibility as needed for project demands. Individuals must be capable of lifting and moving up to 15 pounds when necessary. The role requires extended periods of stationary work using computers and standard office equipment. Effective communication across all employee levels is essential for success in this position.