Remote Senior Staff Mechanical Engineer Job in United States MedTech Startup

Who you are

• Product development from concept to production
• Understand engineering practices product safety root cause analysis
• Design controls FDA regulations proficiency
• Creating and managing requirements
• Bachelor’s degree in mechanical engineering
• Hands-on medical device mechanical design experience
• Minimum 5 years in medical device industry (Class II or III)
• Proficient in ME 3D CAD tools (e.g., Solidworks)
• Verification and validation experience
• Basic mechanics and machine design knowledge
• Design for manufacture and assembly experience
• Strong engineering fundamentals background
• Experience with cross-functional teams and design to manufacturing transition

Desirables

• Team player
• Strong technical leadership
• Comfortable with cross-functional teams
• Strong desire to be part of dynamic mission-driven company
• Excellent technical writing
• Good interpersonal communication
• Ability to multi-task
• Ability to prioritize
• Flexible hours

What the job involves

• Develop mechanical design mechanisms and product development while adhering to all relevant medical device FDA standards and regulations related to handheld instruments
• Utilize analytical tools and technical solutions to solve problems
• Influence processes and infrastructures with potential for upward mobility