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Principal Process Devel Engineer (Class III Devices)--Top $$/Relo Available
RTP, NC, NC 27709 United States
Our client, an RTP area medical device company in high growth mode, is actively recruiting for a top-notch Process Development Engineer to assume key role on its Manufacturing team.
Company will pay absolute top dollar (including relo support ) to attract and retain an excellent candidate.
This company is producing novel, cutting-edge products in the cardiovascular space and is preparing for several commercial launches . At this critical stage in its development, it is essential that the right team is in place to drive scale up and manufacturing. This Engineer will be instrumental in that effort.
Key things to note:
This is a young company with multiple launches planned. Scale-up and tech transfer experience will be important. Experience driving products to completion is expected and required.
These are Class III implantable products, and Class III experience is required. Coating experience is preferred.
This is a highly collaborative role . In addition to leading Manufacturing, this Engineer will partner with R&D and QA (as well as CMOs) in scale-up, process optimization, technology transfer and new product development.
Travel is estimated at < 25%.
Specific duties will include:
Ø Develops and implements manufacturing processes for commercial, clinical and non-clinical product.
Ø Acts as Subject Matter Expert regarding product manufacturing. Leads continuous improvement efforts.
Ø Implements process controls to demonstrate process capability and continuous improvement.
Ø Performs complex Design of Experiments to isolate control variables and problem solve.
Ø Designs, builds, acquires and maintains methods and tools for process improvements .
Ø Works with CMO and other vendors to resolve production and quality issues.
Ø Works with R&D and QA in new product scale-up , process optimization, technology transfer and process validation activities including system qualifications and regulatory submissions.
Ø Establishes operating equipment specifications and improves manufacturing techniques.
Ø Creates, edits and executes protocols and writes protocol reports.
Ø Designs, documents and performs IQ/OQ/PQ and test method qualifications for equipment and processes.
Targeted candidate will offer an Engineering degree (Chemical or Mechanical Engineering preferred) and 8+ years of experience in medical device manufacturing/process development including all/most functions noted above.
Class III experience is a must. Polymer coating and/or cardiovascular experience is preferred.
Other priorities include:
Ø Experience bringing product from R&D into full commercialization
Ø Experience directing and overseeing the work done by external suppliers
Ø Superior project management skills
Ø Strong commitment to continuous improvement
Ø Longevity and impact in previous positions
Finally and critically, we seek a take-charge, get things done leade r. A lot is happening as this company prepares for launch. We seek a highly skilled and driven overachiever who will work exceedingly well in a building setting. Growth potential is enormous .
Frankel Staffing Partners proudly recruits on behalf of premier employers in the Triangle (and beyond). We specialize in Office Support, Life Science and other Professional Services positions. To view our current openings, please visit our website at www.frankelstaffing.com.
North Carolina Biotechnology Center