Electronics / Medical Device Engineer

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

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT.

Position

Electronics / Medical Device Engineer

Location

Indiana

Duration

Long Term

Job Overview

We are looking for an experienced Electronics / Medical Device Engineer with experience in medical device product development, electronics, design controls, and verification activities.

Key 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.

Required Qualifications

• Bachelor's degree in Electrical Engineering, Engineering, or a 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.
• Strong troubleshooting and problem-solving skills.
• Ability to manage multiple tasks and priorities.
• Strong communication and teamwork skills.
• Ability to work effectively with cross-functional teams.
• Electrical Engineering background is preferred.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.