Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting contract opportunity with one of our leading clients!
Title: Engineering Project Manager
Location: Gaithersburg, MD
Duration: 9 months+
- The Project Manager / Combination Product Pilot Line Manager will serve as a technical lead and a core team member of cross-functional combination product pilot line team responsible for building design verification samples.
- Responsible for the technical aspects and implementation of a pilot line that builds new combination products including fill/finish and assemble/pack/label processes.
- Manage implementation and build schedule to make sure design verification samples are delivered in time for drug program schedules.
- Ensure all appropriate documentation for DV sample manufacturing is completed with traceability and quality approval
- Work on complex and technically demanding process development where analysis of data may require an evaluation of multiple variables
- Work in a collaborative matrix structure and interact with co-workers across different functional groups within research and development, regulatory affairs, quality and operations
- Lead process risk assessments and design for manufacturability sessions
- BS or equivalent in Mechanical, Biomedical or related engineering background
- 10 years relevant industry experience
- Will consider a Masters degree or equivalent with at least 8 years relevant experience
- Must have background in Medical Device and/or drug-device combination product development
- Familiar with US and EU regulations.
- Technical experience with common tools and methods used for process development, such as DOE, pFMEA, equipment qualification, process validation and production batch records as examples.
- Experience writing technical documents such as procedures and reports
- Ability to author and follow SOPs, policies, and regulations
- Great teamwork and communication skills, both oral and written, are critical.
- Good prioritization, time management, and organizational skills are required.
- Experience working in cross-functional matrix teams.
- Experienced in SolidWorks 3D CAD
- Understanding of other disciplines within biological process development and research
- Experience using statistical modeling and DoE
- Experience in commonly used manufacturing methods, such as fixture development, injection molding and automated assembly concepts
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Taryn Carbone (firstname.lastname@example.org) for immediate consideration.
Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posting ID: 610199044Posted: 2021-03-08