Jobs

Position Summary and Responsibilities

As Director of Engineering at NOVO Engineering, Inc., you will lead and manage engineering teams to deliver innovative technical solutions for a variety of project types and for multiple projects running in parallel. You will collaborate with senior management and cross-functional teams, oversee project execution from conception to NPI, and ensure quality standards are maintained. Additionally, you will guide integration efforts, manage timelines, and align engineering strategies with overall business goals. This role is dynamic and challenging due to the wide variety of technical projects, demanding customers, and frequent surprises. This is a full-time, on-site position based in Vista, CA.

• Department management
• Engineering resource hiring, management, and allocation
• Development or improvement of systems and processes
• Execution of client projects
• Status reporting on client projects
• Work output quality and professionalism
• Business development support

Qualifications

• Proven experience in Engineering Management and Team Leadership.
• At least 15 years of experience, and at least 5 years in a department or group leadership role.
• Advanced written, spoken, and interpersonal communication skills.
• Medical device development experience, including ISO 13485 and FDA QSR 820 compliance, and implementation of design controls during development.
• A working understanding of the primary engineering disciplines, including mechanical, electrical, firmware, software, and manufacturing engineering.
• Product development experience from inception through transfer to manufacturing
• Experience with the adaptation and implementation of project management systems, including the selection of software tools for managing hardware and software projects, integration processes, and methodologies.
• Proficiency in Project Management, including planning, resource allocation, budget and schedule tracking, and milestone deliverables.
• Strategic thinking and decision-making capabilities to align engineering initiatives with company goals
• BS/MS degree in an Engineering or a related field.
• Familiarity with products from low- to high-complexity that include hardware and software, consumables, and single-use disposables.
• Familiarity with low- to high-volume product designs that utilize a wide variety of manufacturing methods.
• Experience scoping projects and creating both labor and non-labor cost estimates, project schedules, and development plans.

Physical Demands

Physical:

• Requires sitting or standing the majority of the time while working on computer or laptop.

Manual Dexterity:

• Requires manual and digital dexterity to successfully carry out the essential functions of the position.

Audible/Visual Demands:

• Requires ability to hear directions and ability to visually perform essential functions for satisfactory job performance.

Ambulatory:

• The Director of Engineering must be able to perform the essential functions of the position, with or without reasonable accommodation. This role may require movement between office, laboratory, machine shop, manufacturing, and client-site environments; operation of office and engineering equipment; visual inspection of prototypes, components, and test setups; occasional positioning to observe or evaluate equipment and work areas; and occasional lifting or moving of materials or equipment up to 40 pounds. Access to certain work areas may require walking and ascending or descending stairs.

Position Summary and Responsibilities

The Director of Quality Assurance is responsible for leading and overseeing NOVO’s Quality Management System (QMS) to ensure compliance with applicable global regulatory requirements and standards for medical devices. This role provides strategic and operational quality leadership across the organization, with an emphasis on product development. The Director partners with executive leadership and cross-functional teams to drive a strong culture of quality, regulatory compliance, and continuous improvement while enabling business growth and innovation.

• Lead, develop, and maintain NOVO’s Quality Management System in compliance with ISO 13485, FDA 21 CFR 820, and applicable global regulations.
• Provide strategic quality leadership and serve as the primary quality representative for executive management.
• Provide leadership, mentoring, and development of a company-wide quality approach to daily activities.
• Prepare and present QMS Management Reviews.
• Establish and monitor quality objectives, metrics, and KPIs to drive continuous improvement initiatives.
• Lead internal, external, supplier, and regulatory audits.
• Ensure effective corrective and preventive action (CAPA), complaint handling, and nonconformance processes.
• Ensure compliance with document/change control, training, and record-keeping requirements.
• Ensure hardware and software development processes comply with regulatory standards such as ISO 13485, FDA 21 CFR Part 820.30, and IEC 62304.
• Oversee design assurance and product development activities, ensuring compliance throughout the product lifecycle.
  • Lead and coordinate Medical Device File (MDF) documentation deliverables for both hardware and software components of medical device projects.
  • Support the creation, review, and approval of development plans, requirements, design and phase end reviews, risk management file documentation (e.g., risk management plan, hazard analysis, FMEAs, risk reviews, risk report), outputs, verification protocols/reports, and design traceability.
  • Create applicable requirement documents (e.g., system, hardware, software, etc.)
  • Facilitate and participate in comprehensive risk management activities throughout the design process in accordance with ISO 14971, including software-specific risk analysis per IEC 62304.
  • Ensure that risk mitigations are properly documented, tested, and verified.
  • Support design verification activities, including test strategy development, verification test plans, protocols, and reports.
  • Maintain traceability matrices ensuring linkage between product requirements, component requirements, design outputs, risk controls, and verification activities.
  • Participate in design reviews and phase end reviews.
  • Provide quality oversight of change control processes during development.
  • Ensure compliance with project specific standards as applicable (e.g., IEC 60601 (electrical safety) and IEC 62366 (usability).

Qualifications

Skills:

• Expert knowledge of medical device regulations and standards, including FDA 21 CFR 820, ISO 13485, ISO 14971, and applicable international requirements.
• Authority in design controls, risk management, verification, and supplier quality.
• Excellent strategic thinking, problem-solving, and decision-making abilities.
• Proven leadership, people management, and organizational development skills.
• Strong communication and influencing skills, including the ability to present to executive leadership and external regulators.
• Ability to balance compliance and business objectives in a fast-paced environment.

Education/Experience:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field preferred.
• 10+ years of experience in Quality Assurance within the medical device sector.
• 5+ years of leadership experience overseeing quality systems.
• Demonstrated experience leading and maintaining a compliant QMS in a regulated environment.

Preferred:

• Experience supporting Class II and/or Class III medical devices.
• Familiarity with global regulatory frameworks such as EU MDR, MDSAP, and other international markets.
• Background in software-driven devices, combination products, or implantable devices.
• Experience scaling quality systems in a growing or startup medical device company.

Physical Demands

Physical:

• Requires sitting or standing the majority of the time while working on computer or laptop.

Manual Dexterity:

• Requires manual and digital dexterity to successfully carry out the essential functions of the position.

Audible/Visual Demands:

• Requires ability to hear directions and ability to visually perform essential functions for satisfactory job performance.

Ambulatory:

• The Director of Quality Assurance must be able to perform the essential functions of the position, with or without reasonable accommodation. This role may require movement between office, laboratory, machine shop, manufacturing, and client-site environments; operation of office and engineering equipment; visual inspection of prototypes, components, and test setups; occasional positioning to observe or evaluate equipment and work areas; and occasional lifting or moving of materials or equipment up to 40 pounds. Access to certain work areas may require walking and ascending or descending stairs.