Hello, My name is Thomas Gillitzer and I am a Recruiter with The Fountain Group. We are a national staffing firm and are currently seeking a Project Lead-Medical Device Design & Development for a prominent client of ours. This position is located Remotely. Details for the position are as follows:
Job Description: $70-$80 Hourly
- The position will lead the execution of medical devices and packaging projects, ranging from various route of administration like SC, IM, IV, Intrathecal and supporting patient-centric, safe, reliable and innovative devices, digital devices and packaging technology projects, aligned to the drug pipeline, as well as execute, communicate deliverables, plans with internal stakeholders and external partners.
- The position will lead cross functional teams to drive key activities throughout development phases of device and combination products, and facilitate the deliverables to support regulatory filing, product launch and post market surveillance.
- The candidate is considered a device subject matter expert (SME), and will provide project and engineering leadership in device/packaging and/or system identification, feasibility, development, qualification, launch readiness and commercialization for delivery systems and packaging.
- Area of focus will be on leading a development team and where needed providing guidance regarding identification of user needs, product requirements and specification development, feasibility test development, design verification and validation testing, human factors, risk assessments, DHF creation, general project team support, and extensive collaboration with both internal stakeholders and external development partners.
- 10+ years’ experience in design, development and commercialization of medical devices, packaging, project management, tooling, injection molding, extrusion, assembly, and production controls for assembly. Bachelor’s Degree in Engineering required, Master’s Degree or MBA with mechanical or related engineering discipline preferred and 10+ years’ experience.
- Deep understanding of new product introduction, design, and development of extruded, molded and/or assembled device products as well as testing and modeling methodologies.
- Deep knowledge of the regulatory and compliance requirements of device design controls, risk management, human factors (i.e. FDA QSR 21 CFR 820 / ISO13485 quality system requirements, ISO 11608, and other relevant global standards).
If you are interested in hearing more about the position please respond to this posting with your resume attached
The Fountain Group gives you access to more opportunities in your area of expertise and allows you to gain advice and skills training that will help you advance in your chosen career field
The Fountain GroupLooking for a new career, or a change from your current work environment? The Fountain Group gives you access to more opportunities in your area of expertise and allows you to gain advice and skills training that will help you advance in your chosen career field