POSITION SUMMARY: |
The Director of Manufacturing Engineering will be responsible for leading engineering teams in the validation, production, and continuous improvement of medical devices. This position will ensure that all products meet regulatory standards, adhere to the highest quality controls, and align with the needs of both the business and customers. This position requires an expert in medical device manufacturing, with a strong track record of problem solving, project management, and leadership. |
Essential Functions (ACCOUNTABILITIES/RESPONSIBILITIES): |
- Leadership: Lead and manage cross-functional engineering teams in innovation and continuous improvement of the manufacturing of medical devices, from concept through to production.
- Validation: Ensure compliance with relevant regulatory standards, such as FDA 21 CFR Part 820 cGMP and ISO 13485 throughout the product manufacturing lifecycle. Oversee the development and execution of validation processes, including risk management, design control, and testing.
- Engineering Improvement: Drive the initiative for manufacturing development, including identifying emerging solutions to implement lean manufacturing and solutions to achieve business objectives. Improve manufacturing operations by optimizing designs for manufacturability, automation, scalability, and cost efficiency.
- Project Management: Ensure timely, cost-effective delivery of projects, balancing engineering best practices with the need for efficiency by working with internal and external teams. Provide regular status updates and clear communication with senior management regarding project timelines, budget, risks, and progress.
- Sustainability: Lead post-launch activities, including performance monitoring, root cause analysis, and design improvements.
- Team Development: Mentor and grow engineering talent, fostering a culture of collaboration, innovation, and continuous learning.
- Cross-Functional Collaboration: Work closely with regulatory and quality assurance to define clear product requirements and ensure alignment with standards.
- This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
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Qualifications: |
Experience - Proven experience in the manufacturing of medical devices and a strong understanding of FDA 21 CFR Part 820 cGMP, ISO 13485, and other applicable standards.
- Experience with manufacturing processes, design for manufacturability (DFM), and cost reduction strategies in the medical device industry.
Education - Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, Industrial Engineering, or a related field.
General Skills/Competencies/Specialized Knowledge - Proficiency in technical engineering and management tools including Microsoft Office, SolidWorks, and statistical analysis software (Minitab). The ability to lead teams through the complete manufacturing lifecycle, including design, validation, and sustainability. Strong problem-solving skills and experience with risk management processes (e.g., FMEA, hazard and root cause analysis).
- Excellent leadership and communication skills, with the ability to engage and motivate teams while working cross-functionally with other departments and stakeholders. Ability to prioritize and manage multiple projects in a fast-paced, dynamic environment.
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TRAVEL REQUIREMENTS/WORK ENVIRONMENT and PHYSICAL DEMANDS: |
Travel - Up to 25% may be required.
Work Environment and Physical Demands - The primary work environments will be in the office area and in the facility’s production areas.
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