DescriptionPosition Summary: The Manufacturing Engineering Supervisor provides day-to-day oversight and guidance to a team of manufacturing engineers, ensuring smooth operations, compliance with quality standards, and timely execution of projects. This role emphasizes hands-on leadership, coaching, and support to maintain efficient, standardized processes in a regulated medical device contract manufacturing environment. The Supervisor works closely with cross-functional teams and customers to resolve issues, implement improvements, and uphold ISO 13485 and FDA 21 CFR 820 requirements.
Key Responsibilities:- Supervise and coordinate daily activities of manufacturing engineers to meet production and project goals.
- Provide direct guidance and technical support to team members, fostering a collaborative and compliant work environment.
- Monitor progress on tasks and ensure adherence to established timelines and quality standards.
- Assist in implementing and maintaining standardized manufacturing processes and work instructions.
- Support process improvement and cost-reduction initiatives through hands-on involvement.
- Act as a point of contact for internal teams and assist with client interactions as needed.
- Ensure compliance with Cirtec's quality system and regulatory requirements.
- Maintain audit readiness and assist with internal/external audit responses.
- Participate in client meetings, provide technical updates, and support customer audits.
- Maintain regular presence on the manufacturing floor to monitor processes, resolve issues, and ensure compliance during production runs.
- Implement engineering changes quickly, update work instructions, and train operators on new processes.
- Coordinate daily task assignments, prioritize engineering support for urgent builds, and manage shift coverage.
- Conduct in-process quality checks, support CAPA investigations, and ensure document control compliance.
- Supports the tracking and reporting of daily performance metrics, scrap rates, and process efficiency to management and customers.
- Develop training plans, maintain skill matrices, and ensure cross-training for flexibility across product lines.
- Serve as first escalation point for technical issues, equipment downtime, and customer complaints, ensuring rapid resolution.
Must Have:- Bachelor's degree in a STEM discipline
- At least 5 years of experience in medical device manufacturing.
- Minimum 5-7 years in engineering or manufacturing roles with proven ability to supervise technical teams.
- Strong problem-solving and analytical skills with a hands-on approach.
- Familiarity with MES and ERP systems.
- Knowledge of ISO 13485, FDA 21 CFR 820, and regulatory compliance.
- Ability to work under pressure and adapt to changing priorities.
Good to have:- Lean/Six Sigma certification strongly preferred.
Salary Range: 110,000 to 135,000
We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.
