Sr. Manufacturing Engineering Manager
About Us
For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems. Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients.
Position Summary
The Manufacturing Engineering Manager position is primarily responsible for providing functional supervision to engineers and technicians. This role serves as a technical lead for projects, including validation and documentation of existing product services, and is responsible for establishing timelines and deliverables for customers. In addition, the role involves coaching and mentoring direct reports to foster an environment of continuous improvement that exceeds customer expectations.
Key Responsibilities
- Provide support and supervision to direct reports to ensure the timely completion of projects, initiatives, and key activities.
- Mentor associates and foster a learning and growth environment, including performing evaluations at regular intervals.
- Serve as the primary contact with customers, instilling confidence in technical capabilities and product quality.
- Ensure the team operates in compliance with the Cirtec quality system and follows sound engineering practices.
- Ensure products are documented to meet all design requirements in the most efficient manner. Develop processes that are easy to follow, well-documented, and consistently executed by operations.
- Ensure projects remain on schedule and are fully documented in accordance with medical device regulatory requirements.
- Provide leadership to the team executing sustained manufacturing projects, including requirement and specification definition, risk management, design development, process development, prototype builds, device verification testing, process qualification, NCMR dispositioning, ECNs, and CAPA completion.
Qualifications
- Bachelor's degree in an engineering discipline or a technical equivalent degree.
- Minimum of 8 years of experience in an engineering or manufacturing environment.
- Demonstrated ability to lead engineering efforts in a sustained manufacturing environment.
- Strong analytical skills, with the ability to obtain and evaluate secondary research information.
- Ability to meet deadlines and manage projects across multiple departments.
- Ability to handle multiple projects and customers simultaneously.
Preferred Skills
- Experience in a medical device or regulated industry (e.g., FDA, ISO 13485).
- Familiarity with validation processes (IQ/OQ/PQ).
- Experience with Lean or Six Sigma methodologies (Green Belt or Black Belt preferred).
Pay & Benefits
- Salary Range: $120,000-$180,000
- Training and career development
- Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs
- Paid Time Off
- 401(k) retirement savings with a company match