Highlights

The role focuses on maintaining and improving existing product designs, developing solutions to technical problems, coordinating with suppliers and external resources, and supporting verification and product improvement activities. Electrical Engineer responsible for leading electronic product development and end-of-life activities for medical device products.

Description

Electrical Engineer responsible for leading electronic product development and end-of-life activities for medical device products. The role focuses on maintaining and improving existing product designs, developing solutions to technical problems, coordinating with suppliers and external resources, and supporting verification and product improvement activities.

This is a hybrid position in Batesville, IN, with 3 days onsite and 2 days remote each week. The first 1–2 weeks will require full-time onsite work.

Job Responsibilities

Serve as the technical lead for product development and electronic end-of-life activities.
Develop solutions to routine technical problems associated with existing product designs.
Coordinate with suppliers and external resources to update existing designs while maintaining product functionality.
Liaise with external contractors and Operations teams to develop additional capabilities and improve existing products and technology.
Support and participate in cross-functional teams to deliver Voice of Business and project requirements.
Provide clear technical feedback to supervisors and department leadership.
Apply medical device design controls throughout product development activities.
Prioritize and manage multiple engineering tasks and projects.
Utilize engineering tools and methodologies such as Design of Experiments (DOE) and Statistical Process Control (SPC) to solve engineering problems.
Evaluate and recommend techniques to improve existing products.
Help determine appropriate verification testing and other product testing to ensure product design requirements are met.
Support the development and verification of electronic medical equipment with embedded firmware.
Provide technical solutions that consider business objectives, product requirements, and cost implications.
Work effectively as both a leader and member of cross-functional teams.
Follow applicable safety requirements and communicate unsafe conditions, practices, or equipment to management.
Support activities in office, production, laboratory, warehouse, and operating-room environments as required.

Qualifications

Bachelor’s degree in Engineering or Engineering Technology required.
Electrical Engineering preferred.
5–10 years of experience in a design and/or product development environment within the medical device industry.
Experience with medical device design controls.
Experience with new product development (NPD) and product development activities.
Experience developing and verifying electronic medical equipment with embedded firmware.
Working knowledge of FDA 21 CFR 820.30 design controls.
Working knowledge of ISO 9001, Subclause 4.4.
Working knowledge of IEC 60601-1 – Medical Electrical Equipment: General Requirements for Basic Safety and Essential Performance.
Strong understanding of electrical engineering principles and procedures.
Experience using engineering problem-solving tools such as DOE and SPC.
Ability to develop and evaluate product verification and testing requirements.
Ability to prioritize and manage multiple tasks.
Strong analytical and problem-solving skills.
Strong written and verbal communication skills.
Ability to work effectively within and lead cross-functional teams.
Ability to develop solutions aligned with business objectives and cost considerations.
Previous operational experience supporting New Product Development is preferred.
Comfortable working in office, production, laboratory, warehouse, and operating-room environments.
Ability to periodically lift up to 35 pounds.
Ability to work with or around chemicals used in production and laboratory areas.

Skills