Director of Engineering

Our client is an emerging diagnostics company with a revolutionary technology platform for biomarker detection.

As a key member of the management team, the Director will be responsible for the company's sensor and system development activities leading to regulatory clearance and CLIA-waiver in the USA.

The Director will oversee all internal and partnered Engineering Development programs, focus on the structuring and operation of the product development engineering function as a cohesive unit; manage simultaneous projects related to sensor chip and device development; facilitate the delivery of manufacturable designs to agreed specifications within time and budget constraints, and the foster innovative solutions to customer needs.

KEY RESPONSIBILITIES:

• Serve as a key member of the management team that sets the company's strategic direction.

• Develop strategic planning for the direction and control of engineering-related product development activities.

• In an early stage company context, and in collaboration with the CEO, determines the optimal structure for the engineering team, and hires engineering staff to fill the roles as defined

• Oversee the development of the first and subsequent electrode arrays, testing device, and associated software, working closely with external partners as applicable and internal groups to develop manufacturable devices and improve the quality of devices that are already developed.

• Ensure implementation and refinement as required of formal process to support the product development process.

• Ensure that instrument and electrode array product development is focused on meeting and exceeding the customer requirements.

• Ensure that products are designed for specific needs, but with wider applications in mind.

• Formulate long-term objectives and standards of performance for the department to ensure that the company maintains and expands its technology leadership position.

• Lead, manage and develop engineering team members. Provide a clear direction that is in line with the Systems Development department's goals and strategy. Provide a detailed execution plan to meet the group's and individual's goals and milestones.

• Motivate staff and provide technical direction and guidance, as well as hands-on project management, recognizing the role as that of both manager and support resource / mentor.

• Hire and direct staff of senior group members to acquire necessary resources to meet scheduled commitments.

• Assure that department achieves objectives and project completion within budget and time frame.

KNOWLEDGE REQUIRED:

• MS or PhD in engineering, combined with a minimum 10 years industrial experience in the development and manufacturing of FDA-approved diagnostic medical devices.

• Working knowledge of chemistry/biochemistry/biology as they pertain to diagnostic devices

• Working knowledge of a broad range of approaches to quality systems and regulatory compliance pertaining to FDA approval of clinical diagnostic platforms.

• Strong background in Electrical or Mechanical Engineering and device design and fabrication. Extensive experience and knowledge in the area of diagnostic product development, fluidics, manufacturing technologies/ processes, electrochemical detection, nucleic acid hybridization, sample preparation, etc.

• In depth knowledge of regulatory issues pertinent to diagnostic products.

• Practical knowledge of IP and patent application process, as demonstrated by holding of issued patents and/or significant experience in the application and review process.

SKILLS/COMPETENCIES REQUIRED:

• Demonstrated success in achieving commercialization results in a small company environment.

• Proven project management skills: Ability to drive near-term projects to completion within company timelines and budget and to plan and coordinate longer term company objectives.

• Strong relationship management, strategy development, problem solving and change management skills.

• Ability to demonstrate strong leadership, mentorship and direction to Engineering team.

• Manage programs within company and with external partners.

• Able to lead and direct both hardware and software development activities.

• Proven ability to work under pressure and with short deadlines to accomplish objectives.

EXPERIENCE PREFERRED:

• 10+ yrs industry experience in clinical instrumentation and consumable development in a regulated environment; diagnostics experience highly desirable.

• Demonstrated commercial success in instrument and consumable manufacturing.

• Minimum of 5 years progressively responsible management experience, preferably in a diagnostics environment.

• Track record of establishing and managing external collaborations in product development and manufacturing.

• Significant success in management within a small, emerging company environment.

KEY ATTRIBUTES:

• Team player with excellent interpersonal skills

• Pragmatism combined with a 'can do' attitude

• Broad and deep thinking - 'big picture' combined with attention to detail

• Entrepreneurial thinking and work ethic