Electrical Engineer

Planet Pharma; Batesville (IN); On-site; USD 74,000 - 88,000; Full time

Job summary

Planet Pharma seeks an engineering lead for electronics medical devices in Indiana. You will guide design updates, manage end-of-life activities, and coordinate with suppliers to sustain or improve current designs.

The role requires leadership across cross-functional teams, strong knowledge of design controls, and embedded firmware development. Expect a collaborative environment with safety and regulatory emphasis.

Qualifications

• Lead engineering activities for medical device product development.
• Guidance on design controls and regulatory alignment.
• Experience with electronic medical equipment development and verification.

Responsibilities

• Be the technical lead in product development for electronics end-of-life activities.
• Develop solutions to routine technical problems in current designs.
• Coordinate with suppliers and external resources for design updates.
• Liaise with contractors and Operations to add capability and improve products.
• Collaborate with multi-functional teams to meet business and project requirements.

Skills

Technical leadership

Prioritization

Design controls

FDA 21 CFR 820.30

ISO 9001 4.4

IEC 60601-1

Embedded firmware

Cross-functional teamwork

Communication skills

Education

Bachelor's degree in engineering/technology

Electrical Engineering preferred

Job description

Pay range: 54-64/hr
*depending on exp

• 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.

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• 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.

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.