PURPOSE AND REPORTING STRUCTURE:
The Senior Engineer/Consultant will report to the Executives and experienced team leaders in support of customer projects.
Responsibilities
Leads and executes complex Quality Project tasks and assignments with minimal supervision to:
- Develop and implement comprehensive client Quality Management Systems, creating custom solutions as needed.
- Oversee the implementation of complex Quality Management System procedures, ensuring compliance and efficiency.
- Lead and conduct client internal and supplier audits, providing detailed analysis and improvement recommendations.
- Perform in-depth reviews of medical device requirements and specifications, determining gaps and proposing solutions.
- Manage the creation and maintenance of Design History File documents, ensuring regulatory compliance.
Leads and executes complex Regulatory Project tasks and assignments with minimal supervision to:
- Develop comprehensive regulatory strategies and roadmaps for clients.
- Manage the preparation and submission of complex regulatory submissions.
- Conduct and oversee thorough risk assessments and mitigation strategies.
- Lead verification and validation activities, including Software validation and Human Factor studies.
- Represent clients in pre-submission and submission regulatory meetings, preparing and delivering presentations.
PERFORMANCE PROFILE:
The primary role of the Senior Compliance Engineer is to lead the development, implementation, and management of regulatory affairs and quality assurance deliverables across diverse projects and medical device products. The position requires the ability to work independently, manage client relationships, and provide mentorship to junior team members.
First Year Performance Objectives (the “What”)
Experience-based Competencies (the “How”)
Project Management:
- Lead and execute complex projects, ensuring timely delivery and high-quality outcomes
- Accurately estimate project effort and manage project within estimated scope
- Develop and implement project plans, adapting to changing requirements as needed
Client Management:
- Build and maintain strong client relationships, serving as a trusted advisor
- Effectively communicate complex technical information to diverse stakeholders
- Proactively identify and address client needs and concerns
Quality and Regulatory Excellence:
- Ensure compliance with all relevant regulations and standards
- Drive continuous improvement in quality processes and outcomes
- Provide thought leadership in quality and regulatory affairs
Team Leadership:
- Mentor and develop junior team members
- Foster a collaborative and high-performing team environment
- Contribute to the overall growth and success of the department
Financial Management:
- Understand pricing models and ensure project profitability
- Implement effective cost control measures
- Optimize resource allocation across projects
- Advanced project management and planning skills
- Strong leadership and mentoring abilities
- In-depth knowledge of quality systems and regulatory requirements
- Excellence in client relationship management
- Strategic thinking and problem-solving skills
- Project budgeting and estimating skills
- Ability to balance multiple projects and priorities
- Strong analytical and decision-making skills
- Excellent verbal and written communication skills
- Adaptability and resilience in a fast-paced environment
CANDIDATE REQUIREMENTS:
Education and Experience
Bachelor's degree in biomedical engineering, engineering, or related field; advanced degree preferred
- 3+ years of experience in medical device quality and regulatory affairs
- Demonstrated expertise in Quality Management Systems (21 CFR Part 820, ISO 13485:2016)
- Proven track record of successful FDA product submissions or CE mark applications
- Experience with software development lifecycle and software design
- Project management certification (e.g., PMP) preferred
- Experience with Artificial Intelligence FDA submissions preferred
Professional & Personal characteristics:
The Senior Quality Engineer role requires a combination of technical expertise, leadership skills, and business acumen to deliver high-value solutions to clients.
Additional personal traits and values that define the successful candidate include:
- Visionary thinker with the ability to anticipate industry trends and client needs
- Natural leader who inspires and motivates team members
- Strong ethical foundation with unwavering commitment to quality and compliance
- Excellent negotiation and conflict resolution skills
- Ability to thrive in a fast-paced, dynamic environment
- Continuous learner, staying current with industry developments and best practices
- Strategic mindset, aligning project goals with broader business objectives
- Calm and composed under pressure, able to manage multiple deadlines
- Innovative problem-solver, developing creative solutions to complex challenges
- Strong business acumen, understanding the financial aspects of project management
The successful candidate will demonstrate a comprehensive understanding of quality engineering and regulatory affairs, coupled with the leadership skills to drive project success and team development, while ensuring financial viability and client satisfaction.
