PURPOSE

This is an opportunity to join as the Director of Electromechanical Systems and Optical Engineering (Director, Electromechanical Systems) of Pristine Surgical. The successful candidate will contribute to creating and implementing the overall business strategy and direction and will serve as the leader for all electromechanical systems and optical engineering at Pristine. This individual will act as a leader, consultant, and subject matter expert within Pristine, providing guidance and expertise in areas related to electromechanical systems, optical engineering, and development. This person will be responsible for leading the development of Pristine’s endoscopy product platform with setting the strategic direction for the company’s R&D and engineering. The successful candidate will be overseeing the hardware and firmware development of the Pristine product platform for the current product and future product development. The successful candidate will also plan, develop, and implement the overall electromechanical system engineering, firmware, and optical engineering. The responsibilities will include system architecture definition, firmware assessment, optical engineering, detailed engineering assessment, new product development, and sustaining engineering. The position of Director, Electromechanical Systems and Optical Engineering is responsible for setting and leading the global teams and managing all electrotechnical systems development including hardware and firmware for the Pristine product platforms. This position supports the medical device development process including design history file, technical file, and sustaining engineering and the regulatory submission and approval processes. Pristine Surgical is seeking an EE / Masters with at least 15 years’ experience in electromechanical medical device R&D and design for manufacturability.

DUTIES & RESPONSIBILITIES

• Responsible for development, implementation, maintenance and overall success of the company’s electromechanical systems and optical engineering programs and strategy; including establishing firmware development, quality standards/metrics/objectives, developing methods to embed quality into the product development, and manufacturing process.
• Responsible for the firmware development including system development, defining the standards, software validation, and implementation.
• Responsible for driving effective and efficient optical engineering program to assess the optical system design, selection of the architecture and components.
• Works to create and support process enhancement initiatives that deliver an environment of continuous improvement and high-quality output.
• Mix of analog and digital design, with experience designing and debugging modern computing interfaces and peripherals, including USB & I2C, within an NVIDIA, Intel-based computing environment. Experience integrating MCUs such as Texas Instruments MSP platform with higher level CPU architectures.
• Optics expertise including system design, ray tracing, and Zemax tools. Direct experience in developing optics system development, and manufacturing.
• Thorough understanding of image sensors, lens design, and the integration of optical systems.
• Strong experience with Regulatory standards including ISO60601, ISO14971, ISO6230, and compliance of electromechanical systems for CE mark and other regulatory standards.
• Knowledge of electromechanical enclosure design, injection molding tooling planning, and practices.
• Bench and system-level integration/debug/troubleshooting experience. Capable of constructing and testing electrical assemblies. Strong test and debugging skills using test equipment.
• Knowledge of hardware and software security protocols, including potting and encapsulation, surface attack reduction, and component/cable/harness obfuscation.
• Lead supplier qualification, audit, ongoing monitoring, and supplier continuous improvement action plans. Support operations to maintain good relationships with suppliers.
• Manage department budgets against annual development expense and capital requirement forecasts.
• Lead and manage the engineering team including recruiting, hiring, and mentoring team members, fostering a culture of innovation and creativity.
• Understand manufacturing requirements of the products and apply Design for Manufacturing and Assembly during early development phases. Provide ongoing leadership and guidance to manufacturing to address product build needs.
• Applying strong quality methods and mindset, lead methodical product design, analysis, and development of electromechanical systems, including design files, firmware, bill of materials, regulatory testing, security, and quality plans from design concept to manufacturing release, following formal stage gate management. Analyze current designs and products for improvements and/or troubleshooting.
• Research innovative technologies and generate competitive benchmarking data and information by best of breed analysis, testing, and research.

QUALIFICATIONS

• MS degree in Engineering (Computer, Electrical, or Mechanical). PhD with Optical Engineering is preferred. MBA degree a plus.
• 15+ years of experience in electromechanical medical devices and technology development, with a minimum of seven years in a progressively increasing leadership role across multidisciplinary teams.
• Strong experience leading heterogeneous hardware, mechanical, regulatory, project, and embedded engineering teams.
• Strong understanding of software, security and hardware architecture and design, and its extensions into mechanical and regulatory requirements. Thorough understanding of cross-discipline systems interlocks, dependencies, and workflows.
• Must be knowledgeable and conversant in hardware and systems level designs, product development concepts and read, analyze, and interpret technical specifications, procedures, and government regulations.
• Hands on experience with electrical, mechanical, and/or embedded development tools such as Python, Embedded C, C++, Java, Altium, Solidworks, or other applicable tools.
• Demonstrated skills in planning, project budgeting, and risk management techniques. Able to make accurate work estimates and deliver projects within schedule and budget constraints.
• A track record of research and development with successful product innovation and technology development. Demonstrated experience in formal requirements design reviews, DFMEA activities, design for manufacturing reviews, and launch planning.
• Able to travel domestically and internationally.
• Knowledge of software validation and the related standards is preferred.
• Fully competent with all aspects of development and maintenance of the QMS, owning CAPA processes and carrying them out, deviations, SOP writing, and audit readiness.
• Experience with various QMS software, especially Greenlight Guru, Master Control, or similar.
• Experience interfacing with Notified Bodies and State Regulators in an audit capacity.

WORKING CONDITIONS

• Ability to set and meet independent objectives without supervision.
• Comfortable in a fast-paced, flexible, growing organization.
• Able to work effectively in a matrixed work environment and results oriented culture with a high degree of urgency.
• Remote position; however, travel as needed for meetings, labs, and other activities related to job responsibilities.

EMPLOYEE LOCATION(S)

• Southern California preferred.
• Other locations considered for exceptional candidates.

This job description is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions. Additionally, the company reserves the right to revise the job description at any time.

Pristine Surgical offers a comprehensive benefits package that includes medical, dental, and vision insurance, a company sponsored 410(k) plan, and open PTO.

To apply, please email CV and cover letter to hr@pristinesurgical.com.

This is a direct hire position and recruitment firm submissions will not be considered.