One of our large Pharmaceutical clients is actively hiring for a Medical Device Engineer to join their team. This is a fully remote position, however highly prefer candidate to live in EST due 10% travel to the client site. The Medical Device Engineer will work with a cross function team and support new product development, commercialization and life-cycle management activities of medical device and combination products. This person will primarily will be writing & submitting design verification, design validation & design transfer reports supporting the combination product development & quality assurance team. They will need to understand design control processes; including design verification & validation, complaint root cause analysis, deviation management & project management. This role requires strong collaboration with development, quality, procurement departments as well as communication with external suppliers and contract manufacturers.
This contract lasts until December 2024, with potential extensions.
Bachelors in Science, Engineering, or related field
3-5 years experience in engineering, specifically within the Medical Device industry
Experience within Commercialization & New Product Development
Experience in design control for medical device & device risk management
Extensive experience authoring the submissions of Design Transfers
Experience in specification development, change assessments, root cause investigations and device risk management.
Strong technical writing skills
Combination Product Experience, specifically auto injectors, inhalers, or syringes
Change Control experience
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.