USA - Electrical Engineer

Select Source International; Batesville (IN); Hybrid; USD 90,000 - 140,000; Full time

Job summary

Select Source International in Batesville, IN seeks a technically strong leader to drive medical device development, focusing on electronic end-of-life updates and design changes. You will coordinate with suppliers, external resources, and operations to keep existing designs current and compliant.

The role requires a solid foundation in design controls, ability to prioritize multiple tasks, and hands-on experience with firmware development in a multidisciplinary setting.

Qualifications

• Bachelor's degree in engineering/technology required.
• Proficiency in medical device design controls and FDA/ISO standards.
• Experience leading cross-functional teams in product development.

Responsibilities

• Be the technical lead in product development activities for electronic end-of-life updates.
• Coordinate with suppliers and external resources to update existing designs.
• Liaise with contractors and Operations to develop capability for existing technology.
• Lead cross-functional teams to deliver VoB and project requirements.
• Apply design controls and guide team members with prioritization and problem solving.
• Utilize engineering tools (DOE, SPC) to address straightforward technical issues.
• Contribute to verification testing and product testing planning.
• Demonstrate strong communication and cost-aware decision making.

Skills

Design controls

Leadership

Cross-functional

Problem solving

Firmware development

Education

Bachelor's degree in engineering/technology

Tools

Design of Experiments

SPC

Job description

No C2C people -

Only W2 without sponsorship

Description

Hybrid

M-F 3 days oniste, 2 remote

First week or 2 will need to be onsite

• 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 functino. 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. 1. Proficient in Medical Device design controls and provide guidance to team members 2. Ability to prioritize multiple tasks. 3. Utilize engineering tools to solve straightforward problems (e.g., Design of Experiments, SPC, etc). 4. Study and recommend techniques to improve existing products. 5. Help determine verification testing and other product tests to assure product design.
• Working understanding of good practice in the area of 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.

• 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 functino. 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. 1. Proficient in Medical Device design controls and provide guidance to team members 2. Ability to prioritize multiple tasks. 3. Utilize engineering tools to solve straightforward problems (e.g., Design of Experiments, SPC, etc). 4. Study and recommend techniques to improve existing products. 5. Help determine verification testing and other product tests to assure product design.
• Working understanding of good practice in the area of 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.
• Strong communication skills
• Ability to work well as a leader/member of cross-functional teams.

Bachelors Degree (engineering/technology). Electrical Engineering Preferred Five to ten 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. Product development experience in medical device industry.

Every employee is responsible for performing his/her job safely and for calling to managements attention unsafe conditions, practices, or equipment.

Repetitive work with a personal computer. Periodic lifting of up to 35 pounds. Time will be divided between desk-work 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.

Repetitive work with a personal computer. Periodic lifting of up to 35 pounds. Time will be divided between desk-work 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.