Electrical Engineer

Stefanini North America and APAC; Batesville (IN); Hybrid; USD 83,000 - 90,000; Full time

Job summary

Stefanini North America and APAC is seeking an Electrical Engineer for a hybrid role in Indiana, with the first two weeks onsite. You will lead electronic medical device development activities, coordinate with suppliers and external teams, and ensure the design controls and verification testing align with FDA-21 CFR 820 and ISO 9001 requirements.

Contract is 3+ months, first shift, $60-65 per hour on W2 with no PTO, and the project involves cross-functional collaboration across production,

Qualifications

• Electrical Engineering preferred with 5–10 years in a design and/or development setting at a medical device company.
• Experience with Medical Device design controls.
• 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.

Responsibilities

• 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 updates to existing designs to maintain 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.
• 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 FDA-21 CFR 820.30 and ISO 9001 clauses.

Skills

Electrical engineering

Medical device knowledge

Embedded firmware

Education

Electrical Engineering degree

Job description

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

Duration: 03+ 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)