Electrical Engineer

Job Title

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.

Education

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

Experience

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.

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.