Kelly Engineering is currently looking to hire a Project Manager to work for one of our top Pharma clients on-site in Rochester, NY. (long term contract position)
The individual will lead and manage an entire multi-site team through all activities of a development project and ensure fully compliant design history file documentation for a combination (drug/device) product launch, maintain all activity inter-relationships, schedule meetings, provide minutes with status updates for all planned and unplanned activities, provide regular updates to supervisor and management. The role includes working with multidisciplinary teams to ensure combination product medical device development activities follow Design Control Requirements and company procedures. This role will also include activities such as; generation/assistance with Design V&V and Process Validation documentation, assistance/management of MDR compliance/conversion activities and provide Quality Assurance support to other projects as needed.
Qualifications and Experience
- Bachelor’s Degree in engineering or scientific discipline - Chemistry, Biology, Mechanical Engineering, Electrical Engineering \t
- 10 years of experience in Medical Device and/or Pharmaceutical Industry in Quality, R&D, Engineering or Laboratory environment. \t
- Project Management, Design Control and Design History File Expertise. \t
- Prior experience in:\t
- Medical Devices required \t\t
- EU Medical Device Regulation \t\t
- Human Factors and Usability Engineering activities \t\t
- Design Controls (21 CFR 820.30) including Design V&V activities \t\t
- Project Management (MS Project) \t\t
- Process Validation activities \t\t
- Risk Management (ISO 14971) \t
Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity, and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct-hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.
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/nontraditional 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.