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Engineering Leadership Director
3 months ago
Company Overview:
KNG Technical Inc. is a pioneering diagnostics firm specializing in innovative technology platforms for biomarker identification.
Position Summary:
The Director of Engineering will play a crucial role in the management team, overseeing the development of sensors and systems aimed at achieving regulatory approval and CLIA-waiver in the United States.
Key Responsibilities:
- Act as a vital member of the management team, contributing to the strategic vision of the company.
- Formulate strategic plans for engineering-related product development initiatives.
- Collaborate with the CEO to establish the optimal structure for the engineering team and recruit necessary engineering talent.
- Supervise the creation of electrode arrays, testing devices, and associated software, ensuring collaboration with external partners and internal teams to enhance manufacturability and quality.
- Implement and refine formal processes to support product development.
- Ensure product development is aligned with customer requirements and exceeds expectations.
- Design products with specific needs while considering broader applications.
- Set long-term objectives and performance standards to maintain and enhance the company's technological leadership.
- Lead, manage, and mentor engineering team members, providing clear direction aligned with departmental goals.
- Inspire staff and offer technical guidance, balancing management responsibilities with mentorship.
- Recruit and direct senior staff to ensure adequate resources for project commitments.
- Guarantee that departmental objectives and project milestones are met within budget and timelines.
Knowledge and Experience Required:
- MS or PhD in engineering with at least 10 years of industrial experience in developing and manufacturing FDA-approved diagnostic medical devices.
- Proficient understanding of chemistry, biochemistry, and biology related to diagnostic devices.
- Familiarity with quality systems and regulatory compliance for FDA approval of clinical diagnostic platforms.
- Strong background in Electrical or Mechanical Engineering, with extensive experience in diagnostic product development, fluidics, and manufacturing technologies.
- In-depth knowledge of regulatory issues concerning diagnostic products.
- Practical experience with IP and patent processes, evidenced by issued patents or significant involvement in applications.
Skills and Competencies:
- Proven success in commercializing products within a small company setting.
- Strong project management capabilities, with the ability to meet deadlines and coordinate long-term objectives.
- Excellent relationship management, strategic development, problem-solving, and change management skills.
- Demonstrated leadership and mentorship abilities within an engineering team.
- Experience managing both hardware and software development initiatives.
- Ability to perform effectively under pressure and 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.
- Track record of commercial success in instrument and consumable manufacturing.
- A minimum of 5 years of progressively responsible management experience, preferably in diagnostics.
- History of establishing and managing external collaborations in product development and manufacturing.
- Significant success in management roles within a small, emerging company.
Key Attributes:
- Collaborative team player with exceptional interpersonal skills.
- Pragmatic approach combined with a proactive attitude.
- Ability to think broadly while paying attention to detail.
- Entrepreneurial mindset and strong work ethic.