Device Project Lead
Fort Worth, TX
At Advanced Clinical, we’re excited to share with you a great opportunity at for the position of Device Project Lead in the Fort Worth, Texas. The Device Project Lead will manage all technical project activities and apply technical expertise to facilitate the timely development and delivery of new medical device options.
- Coordinate with team members assigned to multiple or complex device development activities
- Support all, and leads multiple, activities related to the development of the assigned device projects
- Proactively contribute to setting, updating and monitoring of team goals
- Design, plan, perform and contribute to projects related to more complex scientific engineering activities and design, plan and perform scientific experiments
- Develop efficient and robust devices and processes for the manufacture and/or analysis of Medical Devices/Combination Products (e.g. tolerance analysis, risk analysis)
- Contribute to risk analyses or peer review and process challenge meetings
- Ensure appropriate planning of workload and resources internally and externally, controlling costs and timescale of the respective project tasks
- Support DRA to prepare multiple Medical Device and Combination Product pre-registration documents and provides input to answer health authority questions
- Drive the evaluation of external device collaborations
- Ensure quality, quantity and timelines in all assigned projects
- A minimum of five years of medical device experience, developing solutions and leading device programs
- Recognized expertise in medical device development
- Strong knowledge of relevant SOP, GLP, DQP, GMP and Device regulations and policies
- Strong presentation skills and scientific and technical writing skills
- Thorough knowledge of state-of-art instrumentation and equipment for broad field of applications
- A minimum of a BS or equivalent in Engineering, Packaging, or applicable discipline
- Advanced degree in applicable engineering discipline (MS, Ph.D. or equivalent) is desirable
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.