Electrical Engineer

Hi,

We are having an immediate requirement for the below mentioned role.

Job Title: Senior Electrical Engineer – Medical Device Product Development

Work Model: Hybrid – 3 days onsite / 2 days remote
Work Location: Batesville, Indiana,
Work Auth: All Visas accepted (No H1 and No Fake Profiles)

Note: Candidate must be available onsite for the first 1–2 weeks .

Job Summary

We are seeking an experienced Senior Electrical Engineer / Medical Device Product Development Engineer to support product development and electronic end-of-life initiatives for existing medical devices.

The ideal candidate will have strong experience with medical device design controls, electronic medical equipment, embedded firmware, verification and validation, and product development within a regulated medical device environment. The engineer will serve as a technical lead and collaborate with cross-functional teams, suppliers, Operations, and external partners to maintain and improve existing products.

Required Education

• Bachelor's degree in Engineering, Technology, or a related technical field
• Electrical Engineering degree strongly preferred

Required Experience

• 5–10 years of experience in design and/or product development within the medical device industry
• Experience with Medical Device Design Controls
• Product development experience involving regulated medical devices
• Experience developing and verifying electronic medical equipment with embedded firmware
• Previous operational experience supporting New Product Development (NPD) preferred

Required Skills

• Strong knowledge of Medical Device Design Controls
• Ability to provide design-control guidance to engineering team members
• Understanding of FDA 21 CFR 820.30
• Knowledge of applicable ISO quality/design control requirements
• Working knowledge of IEC 60601-1 for medical electrical equipment safety and essential performance
• Experience with electronic hardware and embedded firmware development
• Strong understanding of engineering principles, processes, and product development practices
• Experience defining and supporting verification and product testing
• Ability to review and improve existing product designs
• Experience working with suppliers and external engineering partners
• Familiarity with engineering/statistical tools such as:
  • Design of Experiments (DOE)
  • Statistical Process Control (SPC)
• Strong troubleshooting and problem-solving skills
• Ability to manage multiple priorities simultaneously
• Strong written and verbal communication skills
• Experience working in and supporting cross-functional teams
• Understanding of business objectives and cost implications when developing engineering solutions

Key Responsibilities

• Serve as the technical lead for electronic product development and end-of-life activities
• Develop engineering solutions for issues associated with existing medical device designs
• Coordinate with suppliers and external resources to implement updates to existing products
• Support electronic component obsolescence and product lifecycle activities
• Work with Operations and external contractors to improve existing technology and product capabilities
• Provide technical guidance related to medical device design controls
• Collaborate with cross-functional teams to deliver business and project requirements
• Define and support verification testing required to confirm product design
• Investigate technical issues and recommend improvements to existing products
• Utilize engineering tools such as DOE and SPC to support problem resolution
• Provide clear project and technical updates to management and engineering teams
• Consider quality, regulatory, technical, business, and cost requirements when developing solutions

Work Environment

• Hybrid schedule: 3 days onsite and 2 days remote
• First 1–2 weeks onsite
• Combination of office, laboratory, production, and warehouse environments
• Periodic lifting of up to 35 lbs
• May work around chemicals routinely used in production and laboratory environments
• May occasionally be required to observe surgical procedures in an operating-room environment