Hardware Design Engineer

Job Title: Medical Device Engineer

Responsibilities

• Lead and manage critical activities related to maintaining and improving electro-mechanical medical device design, manufacturing, and service processes.
• Participate in reliability studies and lead troubleshooting activities, investigating root causes to successful conclusions and resolving product complaints and CAPA.
• Provide alternatives to end-of-life for electrical components.
• Conduct research and testing to solve problems, ensuring functionality, safety, and effectiveness of devices.
• Develop prototypes and conduct testing to ensure devices meet customer needs, design requirements, and regulatory standards.
• Work closely with cross-functional teams, including mechanical engineers, process engineers, quality, and regulatory, to ensure device safety, compliance, compatibility, functionality, manufacturability, and serviceability.
• Ensure compliance with relevant regulations and standards, such as FDA and IEC series.
• Develop detailed electrical drawings and document design processes and test results.
• Execute the Engineering Change Order (ECO) process per Design Controls – Design Change regulations and internal policies.

Qualifications:

• Bachelor's Degree in Electrical Engineering, Mechanical Engineering, other relevant Engineering discipline.
• 7+ years Electrical engineering experience in a heavily regulated industry (e.g., automotive, medical).
• Electrical engineering experience in the medical device industry.
• Printed circuit board design and analysis experience and understanding.
• Experience with Altium Designer or other electrical PCB design software.
• Strong technical and problem-solving skills.
• Ability to communicate and write effectively.
• Emotional self-management in difficult situations.
• Understanding of process validation and statistical analysis.
• Understanding and application of ISO 13485 quality management system requirements.
• Understanding of FDA Design Controls and EU Medical Device Directive (CE Marking requirements).