Principal Engineer, Medical Device/Delivery Systems – RTP/Top $$
Our client, an RTP-based company in high growth mode, is actively recruiting for a top-notch Medical Device Design Engineer who will lead the development of its implant delivery devices for extended-release products from the design phase to clinical supply manufacturing (and beyond).
This is a critical role and company will pay absolute top dollar to attract and retain a star.
Key Things to Note:
- This company is one of the fastest growing companies in the Triangle. It is developing a portfolio of highly anticipated products, with several near-launch and a rich and expanding pipeline. The future is very bright.
- The company uses external suppliers and contractors for the manufacture of its products. This Principal Engineer will be responsible for selection, transition and oversight of these partners. Ability to assess manufacturability, reliability and functionality will be essential.
- This is a transition phase, moving from manual to semi-automated processes. Seek candidate with directly related experience. Six Sigma bkgd and/or mindset will be important.
- These are delivery mechanisms for extended release, sterile products. Similar exposure is required.
- This is an independent contributor role, responsible for the oversight of key programs and suppliers. Seek candidate who enjoys SME responsibilities as well as program/project management.
Specific Responsibilities Include:
- Develop manufacturing plans for extended release products and delivery systems from preclinical through phase 3 clinical development
- Provide technical leadership for the development, tech transfer, and qualification of manufacturing processes for sterile drug delivery systems in non-clinical (GLP and non-GLP) and cGMP clinical development
- Drive concept development, prototyping, product design, verification/validation testing, including authoring protocols/technical reports, and support through production scale up and transfer.
- Create and maintain design control related documentation such as risk and usability assessments, user needs, design inputs, etc. Ensure compliance with requirements of design controls and other regulatory bodies for direct contributions to regulatory submissions.
- Write, review and approve Applicator Assembly, Manufacturing and Controls (CMC) documents, including development protocols and reports.
- Analyze and summarize complex data sets, including the use of appropriate statistical tools for the identification of Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs)
- Take a leadership role in the development of material specifications, performance and shelf-life estimates
- Create and review project plans and timelines and assist in execution to ensure all projects are appropriately prioritized and key goals are met on time and within budget
- Communicate project status to management and project leadership
- Effectively work within the Development department and with cross-functional team leaders to achieve corporate and program goals
- Help ensure overall operational spend is within the approved budget and timeline
Targeted candidate will offer an Engineering degree and 8 plus years of cGMP drug product and/or medical device development experience, including 3+ years in device engineering. Significant experience with Clinical Supply and Drug Delivery Systems expected and important.
Other priorities include:
- Demonstrated ability to establish integrated process optimization processes (internal and external manufacture) and scale-up manufacturing, including Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) supplies
- Extensive hands-on experience in pharmaceutical process development, device design, and drug product manufacturing
- Experience selecting, engaging and overseeing external suppliers for the manufacture of delivery systems
- Demonstrated ability to establish and maintain relationships with high expectations and high levels of delivery for internal and external suppliers, while developing a safe and effective delivery system for developmental drug products
- Strong writing and documentation skills, including the maintenance of impeccable Design History Files
- Outstanding Project Management skills
- Demonstrated ability to engage and lead cross-functional teams
- Longevity and impact in previous roles
Finally, and critically, we seek a forward-thinking quick study who will thrive in this emerging and collaborative setting; an innovative, process improvement-focused candidate who will have significant impact. The future is very bright. We seek a leader who will contribute and thrive.
Please forward resume for prompt consideration. Local candidates only.