This position will be primarily responsible the design of consumables products and automation in a quality systems FDA and ISO 13485 regulated environment. The R&D Engineer will report directly to a Senior Engineer and will be working both independently and in the R & D team. Duties will include prototype development, scale-up, and testing/validation of products and automated solutions for production.
All steps in the design phase of the products should be properly documented in laboratory notebooks and design documents by the Research & Development Engineer.
Research & Development Engineer is responsible for safe handling of chemicals and control of hazardous waste.
- Works with the Senior Engineer, Design Coordinator, Research & Development Director, and other assigned scientists and technicians in achieving product development objectives and goals in a timely manner.
- Independently works while following good laboratory practices. Understands design controls and follows design control procedures as specified by Research and Development Director and the QMS. Follows the NPD Stage Gate Process and R and D Operating Model for new development projects.
- Responsible for the development of automation, scale up, and validation of equipment as necessary.
- Tests equipment and products to ensure conformance to FDA and ISO regulations. Works on projects as assigned by Senior Engineer and Project Management.
- Conducts work on site in compliance with all quality and safety rules and regulations.
- Trains Quality Control and Research & Development technicians on equipment as necessary.
Required Knowledge, Skills and Abilities:
- Master’s degree in Engineering or Sciences or equivalent work-experience required.
- The person in this position will need to think outside the box, be confident in their abilities, and carry out design projects autonomously as assigned.
- Knowledge of automation, sterilizers, plumbing, electrical, RF, integrated circuits and prototype development is highly desired.
- Previous medical device development experience, preferably in the consumables/single use market segment.
- Minimum of 5 years’ experience as a product development engineer.
- Knowledge of and experience in medical device development, equipment and process qualification, automation, sterilizers and Solidworks.
- Extensive technical domain know-how and understanding of adjacent functions.
- Should have a good track record of previous engineering development projects.
- Must have the ability to independently develop, design and execute innovative solutions and mentor junior engineers. Must be organized and have good communication in a cross-functional matrix environment.
- Ability to read, interpret and test according to ISO standards is a must.
- Need to possess good computer skills, Solidworks, and have the ability to use LabView programming to interface with sterilization equipment.
- Understanding of medical device design control regulations is desired.
- Experience in sterilization or FDA / ISO 13485 medical device design is highly desirable.
- 3 years + experience in electrical and/or mechanical and automation engineering is preferable.
- Knowledge of automation, sterilizers, electrical, RF, integrated circuits and prototype development is highly desired.
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.
Job Type: Full-time
- Design Controls: 1 year (Preferred)
- ISO 13485: 1 year (Preferred)