Electrical Engineer

Centillion Infotech LLC; Batesville (IN); Hybrid; USD 80,000 - 120,000; Part time

Job summary

Centillion Infotech LLC is seeking an Electrical Engineer in Batesville, IN for a temporary, 10-month engagement. The role focuses on electronics design, medical device development, and ensuring compliance with FDA 21 CFR 820.30 and ISO standards.

Hybrid work arrangement required with 3 days onsite and 2 remote, first 1–2 weeks onsite. Required are 5–10 years in medical device design/development, a Bachelor's in engineering/technology, and experience with design controls.

Qualifications

• Bachelor's degree in engineering/technology required; electrical engineering BA/BS preferred.
• 5–10 years of design/development experience in medical devices.
• Experience with Medical Device design controls (FDA 21 CFR 820.30) and ISO 9001 basics.

Responsibilities

• Serve as technical lead in product development for electronic devices.
• Develop solutions for routine design problems and updates to existing designs.
• Coordinate with suppliers and external resources to implement design updates.
• Collaborate with Operations and cross-functional teams to meet project requirements.
• Provide guidance on verification testing and product tests to assure design objective.

Skills

Electrical Engineer

FDA

Medical device

NPI

Design controls

Cross-functional teamwork

Leadership

Communication

Education

Bachelor's Degree in engineering/technology

Electrical Engineering degree preferred

Job description

Job Title: Electrical Engineer

Job Location: Batesville, IN, USA, 47006

Employment Type: Temporary

Estimated Duration: 10 Months

Skills/Attributes: Electrical Engineer, FDA, Medical device, NPI - New Product Introduction

Position Description:
Work Arrangement

• Hybrid
• Monday Friday, 3 days onsite, 2 remote
• First 1 2 weeks must be onsite

Education Required

• Bachelor's Degree in engineering/technology
• Electrical Engineering degree preferred

Experience Required

• 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 (preferred)
• Product development experience in the medical device industry

Skills Required

• Proficient in Medical Device design controls; able to provide guidance to team members
• Working understanding of design controls, including FDA 21 CFR 820.30 and ISO 9001 sub-clause 4.4
• Working understanding of IEC 60601-1 (medical electrical equipment general safety and essential performance)
• Experience with development and verification of electronic medical equipment with embedded firmware
• Solid technical understanding of engineering principles and procedures
• Ability to prioritize multiple tasks
• Ability to use engineering tools to solve straightforward problems (e.g., Design of Experiments, SPC)
• Ability to study and recommend techniques to improve existing products
• Ability to help determine verification testing and other product tests to assure product design
• Effectively operate in and may facilitate cross-functional teams with guidance
• Ability to provide solutions that reflect understanding of business objectives and cost implications
• Strong communication skills
• Ability to work well as a leader/member of cross-functional teams

Job Description

• Serve as 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 to develop and implement updates to existing 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
• 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

Physical / Environmental Requirements

• Repetitive work with a personal computer
• Periodic lifting of up to 35 pounds
• Time divided between desk work in a standard office environment and standing/moving 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