Senior Electronics & Medical Device Engineer

Stark Pharma Solutions Inc; Cincinnati (IN); On-site; USD 80,000 - 120,000; Full time

Job summary

Stark Pharma Solutions Inc. in Indiana is seeking an experienced Electronics / Medical Device Engineer to lead electronic product development for medical devices, with emphasis on design controls, verification, and cross‑functional collaboration.

The role requires troubleshooting, collaboration with suppliers and internal teams, and contributions to NPD and product improvements, applying DOE, SPC, and regulatory knowledge (FDA 21 CFR 820.30, IEC 60601-1) to deliver robust medical electronics.

Qualifications

• Bachelor’s degree in Electrical Engineering or related field.
• 5–10 years of engineering design or product development experience.
• 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 and ISO 9001.
• Knowledge of IEC 60601-1.
• Strong troubleshooting and problem-solving skills.
• Ability to manage multiple tasks and priorities.
• Strong communication and teamwork skills.

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.
• Use engineering tools such as DOE and SPC to solve product-related problems.
• Support New Product Development and product improvement 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

Electrical Engineering

Embedded firmware

Troubleshooting

Cross-functional teamwork

Product development

Quality & Regulatory awareness

Communication skills

Education

Bachelor's degree in Electrical Engineering

Tools

Design Controls

DOE

SPC

FDA 21 CFR 820.30

Job description

Stark Pharma Solutions Inc. in Indiana is seeking an experienced Electronics / Medical Device Engineer to lead electronic product development for medical devices, with emphasis on design controls, verification, and cross‑functional collaboration.

The role requires troubleshooting, collaboration with suppliers and internal teams, and contributions to NPD and product improvements, applying DOE, SPC, and regulatory knowledge (FDA 21 CFR 820.30, IEC 60601-1) to deliver robust medical electronics.