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Engineering Leadership Director
3 months ago
Company Overview:
KNG Technical Inc. is a pioneering diagnostics firm specializing in innovative technology solutions for biomarker identification.
Position Summary:
The Director of Engineering will play a crucial role within the management team, spearheading the company's sensor and system development initiatives aimed at achieving regulatory approval and CLIA-waiver in the United States.
Key Responsibilities:
- Act as a vital member of the management team responsible for shaping the strategic vision of the company.
- Formulate strategic plans to guide and oversee engineering-related product development efforts.
- In collaboration with the CEO, establish the optimal structure for the engineering team and recruit necessary engineering talent.
- Supervise the creation of initial and subsequent electrode arrays, testing devices, and associated software, collaborating closely with external partners and internal teams to ensure manufacturable designs and enhance existing device quality.
- Implement and refine formal processes to support the product development lifecycle.
- Ensure that product development for instruments and electrode arrays aligns with and surpasses customer expectations.
- Design products with specific applications in mind while considering broader usability.
- Set long-term objectives and performance standards for the department to uphold and expand the company's technological leadership.
- Lead, manage, and cultivate engineering team members, providing clear direction aligned with departmental goals and strategies.
- Inspire and guide staff through technical direction and hands-on project management, serving as both a manager and mentor.
- Recruit and manage senior team members to secure the necessary resources for timely project completion.
- Ensure departmental objectives are met within budgetary and time constraints.
Knowledge and Qualifications:
- Master's or PhD in engineering, with at least 10 years of industrial experience in developing and manufacturing FDA-approved diagnostic medical devices.
- Familiarity with chemistry, biochemistry, and biology as they relate to diagnostic devices.
- Comprehensive understanding of quality systems and regulatory compliance for FDA approval of clinical diagnostic platforms.
- Strong background in Electrical or Mechanical Engineering, device design, and fabrication, with extensive experience in diagnostic product development, fluidics, and manufacturing technologies.
- In-depth knowledge of regulatory issues relevant to diagnostic products.
- Practical experience with intellectual property and patent processes, evidenced by issued patents or significant involvement in application and review processes.
Skills and Competencies:
- Proven track record of achieving commercialization results in a small company setting.
- Exceptional project management skills, with the ability to drive projects to completion within timelines and budgets.
- Strong relationship management, strategic development, problem-solving, and change management abilities.
- Demonstrated leadership and mentorship capabilities within an engineering team.
- Experience managing programs both internally and with external partners.
- Ability to lead and coordinate both hardware and software development efforts.
- Proven capability to perform under pressure and meet tight deadlines.
Preferred Experience:
- Over 10 years of industry experience in clinical instrumentation and consumable development within a regulated environment; diagnostics experience is highly desirable.
- Demonstrated commercial success in instrument and consumable manufacturing.
- A minimum of 5 years of progressively responsible management experience, preferably in a diagnostics context.
- History of establishing and managing external collaborations in product development and manufacturing.
- Significant success in management roles within a small, emerging company environment.
Key Attributes:
- Collaborative team player with strong interpersonal skills.
- Pragmatic approach combined with a proactive attitude.
- Ability to think broadly while paying attention to detail.
- Entrepreneurial mindset and work ethic.