Senior Electronics Engineer - Medical Devices & Product Dev

Stark Pharma Solutions Inc; Bloomfield (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

Stark Pharma Solutions Inc. in Indiana seeks an Electronics / Medical Device Engineer to lead electronic product development, design controls, and verification activities for medical devices.

You will collaborate with cross-functional teams, support NPD and product improvements, troubleshoot complex issues, and apply DOE, SPC and risk management per FDA/ISO requirements. A Bachelor's degree in Electrical Engineering and 5–10 years of experience are required.

Qualifications

• Bachelor's degree in Electrical Engineering or related field.
• 5–10 years of experience in engineering design or product development.
• Experience in the medical device industry.
• Experience with Medical Device Design Controls.
• Experience developing and verifying electronic medical equipment.
• Experience with embedded firmware.
• Knowledge of FDA 21 CFR 820.30.
• Knowledge of ISO 9001 requirements.
• Knowledge of IEC 60601-1.
• Experience with design verification and product testing.
• Experience supporting New Product Development.
• Knowledge of DOE, SPC, and other engineering problem-solving methods.

Responsibilities

• Lead electronic product development and end-of-life activities.
• Support updates and improvements to existing medical device products.
• Troubleshoot and solve technical problems related to product design.
• Coordinate with suppliers, contractors, and external engineering teams.
• Work with Engineering, Operations, Quality, and other cross-functional teams.
• Support product verification and testing activities.
• Provide technical guidance and feedback to team members.
• Develop solutions based on technical, business, and cost requirements.
• Support medical device design control activities.
• Communicate project updates and technical information clearly.

Skills

Troubleshooting

Cross-functional teamwork

Communication

Electrical Engineering know-how

Education

Bachelor's degree in Electrical Engineering

Tools

DOE

SPC

Design Controls

FDA/IEC standards

Job description

Stark Pharma Solutions Inc. in Indiana seeks an Electronics / Medical Device Engineer to lead electronic product development, design controls, and verification activities for medical devices.

You will collaborate with cross-functional teams, support NPD and product improvements, troubleshoot complex issues, and apply DOE, SPC and risk management per FDA/ISO requirements. A Bachelor's degree in Electrical Engineering and 5–10 years of experience are required.