Manufacturing Engineering Team Lead

About the role

The Manufacturing Engineering Supervisor oversees and guides a team of manufacturing engineers to ensure smooth operations, compliance with quality standards, and timely project execution. This role requires hands-on leadership, coaching, and support to maintain efficient, standardized processes in a regulated medical device contract manufacturing environment. The Supervisor collaborates with cross-functional teams and clients to resolve issues, implement improvements, and adhere to ISO 13485 and FDA 21 CFR 820 requirements.

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.
• Aid 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.
• Cook up 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.
• Serve as first escalation point for technical issues, equipment downtime, and customer complaints, ensuring rapid resolution.

Requirements

• 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

Qualifications

• Good to have: Lean/Six Sigma certification

Skills

• Leadership
• Technical proficiency
• Problem-solving
• Collaboration
• Compliance

Benefits

• 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

Pay

$110,000 to $135,000 annually

Schedule

Full-time position