Mechanical Design Engineer II (Manufacturing & Tooling – Medical Devices)

About the Role

The Mechanical Design Engineer II role is designed to develop professional work knowledge and abilities while supporting projects of global importance. You will work on manufacturing processes, collaborating with production and cross-departmental engineering teams to resolve production floor issues. This position involves evaluating, selecting, and applying engineering techniques to develop and implement adaptations and modifications for equipment, tooling, and fixturing.

Responsibilities

• Solve problems and implement innovative solutions for manufacturing processes.
• Create designs and drawings for Engineering, Production, and Research and Development teams.
• Develop new equipment, fixtures, and related processes for medical devices and components.
• Execute detailed root cause analysis and recommend vetted solutions.
• Communicate problems and solutions cross-functionally and interdepartmentally.
• Support production by creating and maintaining documentation.
• Monitor equipment performance and implement process improvements to optimize yield, efficiency, and throughput.
• Design fixtures, acquire off-the-shelf tooling and equipment, and implement new fixtures on the production line.
• Perform equipment qualifications and develop specifications for tooling, fixtures, or equipment.
• Coordinate with suppliers and external resources to develop and implement improvements.
• Participate in project planning and scheduling.
• Train assemblers, quality control, and technicians on processes, equipment, and documentation.
• Adhere to the Company’s Quality Management System (QMS) and ensure compliance with domestic and global quality regulations, standards, and procedures.
• Understand and apply relevant security, privacy, and compliance principles.
• Perform other work-related duties as assigned.

Requirements

• Bachelor's degree in Engineering or related technical field with 1+ years of relevant engineering experience, or equivalent combination of education and technical experience.
• Excellent written, verbal, and interpersonal communication skills.
• Proficiency in Word, Excel, PowerPoint, Access, and other computer applications.
• High degree of accuracy and attention to detail.
• Excellent organizational skills with the ability to prioritize assignments while handling multiple projects.

Preferred Qualifications

• Engineering experience in a manufacturing environment, preferably in the medical device industry.
• Knowledge of FDA regulations, Lean/Flow Manufacturing, and/or materials and manufacturing processes.

Working Conditions

• General office environment; class 10,000 cleanroom.
• On-site work required.
• Potential exposure to blood-borne pathogens.
• Requires lifting and moving up to 15 pounds.
• Ability to move between buildings and floors.
• Must be able to remain stationary and use standard office equipment (e.g., computer, printer) for extended periods.
• Must be able to read, prepare emails, and produce documents and spreadsheets.
• Must be able to communicate and exchange accurate information with employees at all levels daily.

Pay

Annual base salary range: $95,000 to $120,000. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

Benefits

• Competitive compensation package plus benefits and equity program (when applicable).
• Medical, dental, vision, life, and AD&D insurance.
• Short and long-term disability insurance.
• 401(k) with employer match.
• Paid parental leave.
• Eleven paid company holidays per year.
• Minimum of fifteen days of accrued vacation per year (increases with tenure).
• Paid sick time in compliance with applicable laws.