Engineering Director

Jobtailor; Colorado; On-site; USD 180,000 - 280,000; Full time

Job summary

Jobtailor in Colorado is seeking a senior leader to head the Surgical Operating Unit’s New Product Development Risk Management and Reliability Quality team, aligning initiatives with business goals and regulatory requirements.

You will drive performance, guide cross-functional teams, manage budgets, and ensure patient safety across the full product lifecycle while continuously improving QMS, risk management, and design controls in a fast-paced medical-device environment.

Qualifications

• Bachelor's degree in engineering or technical field required.
• Minimum 10 years in Quality NPD or 8 years with advanced degree.
• 7+ years of managerial experience.
• Strong background in Quality New Product Development.
• Expertise in reliability science, risk management, design controls, regulatory compliance.
• Ability to influence across a matrixed organization.
• Familiarity with ISO 14971, ISO 13485, IEC 62304, FDA Part 820.

Responsibilities

• Lead and develop the Surgical Operating Unit’s NPD Risk Management and Reliability Quality team.
• Provide strategic leadership to align initiatives with business goals.
• Establish performance goals and conduct reviews for staff development.
• Direct design and development of medical device products and systems.
• Develop, implement, and improve objectives, policies, and standards.
• Hire and develop talent for key programs and roles.
• Collaborate across functions to balance priorities and influence stakeholders.
• Manage departmental budget and resource allocation.
• Maintain risk management files, plans, reports, and reviews.
• Ensure regulatory compliance and quality standards across NPD activities.
• Serve as a key quality leader focusing on patient safety throughout lifecycle.

Skills

Leadership

Risk management

Cross-functional collaboration

Regulatory compliance

Quality management systems

Statistical analysis

Problem solving

Learning agility

Influence across matrix

Education

Bachelor's degree in engineering or technical field

Advanced degree (MS/PhD) preferred

Tools

CQE

Six Sigma Green Belt

AAMI design control

Job description

• Lead and develop the Surgical Operating Unit’s New Product Development Risk Management and Reliability Quality team
• Provide strategic leadership to prioritize departmental initiatives and align team goals with broader business and functional objectives
• Establish performance goals and targets, conduct performance reviews, and lead regular one‑on‑one discussions to support employee development and performance management
• Direct and guide employees in the design and development of medical device products and systems
• Develop, implement, and continuously improve objectives, policies, processes, and standards to support business strategy and drive functional excellence through best practices
• Select, hire, and develop talent, ensuring the right capabilities are aligned to the right programs and roles for efficient and effective team performance
• Collaborate effectively across functions and businesses, balancing competing priorities and influencing stakeholders to achieve shared outcomes
• Manage the departmental budget and ensure effective allocation of resources
• Lead the team in creating and maintaining the risk management file, including risk management plans and reports, and conducting regular risk reviews
• Ensure quality deliverables for new product development activities are executed in compliance with applicable regulatory requirements and internal quality standards
• Serve as a key quality leader in the medical device development process, with a strong focus on patient safety across the full product lifecycle

Requirements

• Bachelor of Engineering or technical degree required
• Minimum of 10 years of relevant experience which includes experience in Quality New Product Development or advanced degree with a minimum of 8 years of experience
• 7+ years of managerial experience to include demonstrated people leadership experience
• Strong background in Quality New Product Development
• Expertise in reliability science, risk management, design controls, and regulatory compliance
• Ability to work effectively in cross‑functional teams and influence across a matrixed organization
• Strong initiative, curiosity, learning agility, and problem‑solving skills
• Expertise in quality management systems and statistical methods and analysis
• Certifications: Certified Quality Engineer (CQE)
• Six Sigma Green Belt or equivalent certification
• AAMI design control certification
• Industry Experience: Medical device industry experience
• Understanding of relevant regulatory requirements, including ISO 14971, ISO 13485, IEC 62304, and FDA Part 820
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Core Competencies

Demonstrates expertise in Quality New Product Development, Risk Management, and Regulatory Compliance within the medical device industry, while effectively leading cross‑functional teams to achieve strategic objectives and ensure patient safety throughout the product lifecycle.