Electrical Engineer

Stefanini Group; Batesville (IN); Hybrid; USD 171,924,000 - 186,252,000; Full time

Job summary

Stefanini Group is seeking an Electrical Engineer for a hybrid role in Batesville, IN. First two weeks onsite, then hybrid work. Pay rate is $60-65 per hour on W2 with no PTO.

Contract length 06-12 months with possible extension. The role focuses on leading electronic development, design controls, and cross-functional collaboration with suppliers and operations to enhance existing technology. Ideal candidates will have 5–10 years in medical device design/development, familiarity with FDA/IEC

Qualifications

• Electrical Engineering degree preferred and relevant medical device experience.
• 5–10 years in design/development for medical devices.
• Experience with Medical Device design controls (FDA/IEC standards) is required.
• Operational experience supporting New Product Development is preferred.
• Ability to perform physical tasks as some roles require production area presence.

Responsibilities

• Lead electronic product development activities for end-of-life projects.
• Develop solutions to routine technical problems in current designs.
• Coordinate with suppliers and external resources for updates.
• Collaborate with Operations to enable new capabilities.
• Provide guidance on design controls and verification testing.

Skills

Electrical engineering

Project leadership

Cross-functional teamwork

Embedded firmware

Education

Electrical Engineering degree (preferred)

Tools

FDA 21 CFR 820 knowledge

IEC 60601-1 knowledge

Job description

Job Title: Electrical Engineer (Hybrid role) (First two weeks need to be onsite)

Duration: 06-12 months contract (Possible Extension)

Timing: 1st shift (Monday to Friday).

Pay rate: $60-65/- hourly on W2 with 0 PTO

Job Description:

• Be the technical lead in product development activities for electronic end of life activities.
• Develop solutions to routine technical problems associated with current product design Coordinate with suppliers and external resources needed in developing and implementing update to exiting designs to maintain existing function.
• Liaise with exterior contractors and Operations teams to develop additional capability for existing technology and product improvements.
• Function within a team environment and provide clear feedback to supervisor and department.
• Work with multi-functional team to deliver Voice of Business and Project requirements.
• Proficient in Medical Device design controls and provide guidance to team members.
• Ability to prioritize multiple tasks.
• Utilize engineering tools to solve straightforward problems (e.g., Design of Experiments, SPC, etc.).
• Study and recommend techniques to improve existing products.
• Help determine verification testing and other product tests to assure product design.
• Working understanding of good practice in design controls, including FDA-21 CFR 820.30 and sub clause 4.4 of ISO 9001.
• Working understanding of IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Experience with the development and verification of electronic medical equipment with embedded firmware
• Display a solid technical understanding of engineering principles and procedures.
• Effectively operate in and may facilitate cross-functional teams with guidance.
• Must be able to provide solutions that reflect understanding business objectives and cost implications.
• Ability to work well as a leader/member of cross-functional teams.

Education/Experience Required:-

• Electrical Engineering Preferred 5-10 years of experience in a design and/or development setting at a medical device company.
• Experience with Medical Device design controls.
• Previous Operational experience supporting New Product Development is preferred.
• Every employee is responsible for performing his/her job safely and for calling to management’s attention unsafe conditions, practices, or equipment.
• Repetitive work with a personal computer.
• Periodic lifting of up to 35 pounds.
• Time will be divided between deskwork in a standard office environment and standing/moving about especially in production, laboratory, and warehouse areas.
• A variety of chemicals are used in production and laboratory areas routinely.
• Time will be divided between deskwork in a standard office environment and standing/moving about especially in production, laboratory, and warehouse areas.
• A variety of chemicals are used in production and laboratory areas routinely.
• May be required to observe surgical procedures while in an operating theater.

Best regards,

Rachit Rastogi (Rick)