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