Manufacturing Engineering Team Lead

Manufacturing Engineering Team Lead Lowell, MA Job Details Full-time $110,000 - $135,000 a year 1 day ago Benefits Health insurance Dental insurance Paid time off Vision insurance 401(k) matching Qualifications Quality control corrective actions Project team coordination Six Sigma Certification Manufacturing management ISO standards 5 years Regulatory compliance ERP systems Engineering process optimization Shift management Corrective and preventive actions (CAPA) Technical support Compliance management implementation Manufacturing standard operating procedures Team development Key Performance Indicators Analysis skills Supervising experience Bachelor's degree Team management Performance Improvement (PI) Technical skills instruction Quality audits Training & development Quality assurance within manufacturing Senior level Document management Cross-functional collaboration Escalation handling Implementing cost-saving initiatives Manufacturing company experience Lean Six Sigma Certification Implementing lean manufacturing processes Process engineering Cross-functional communication Progress tracking (project management tasks) FDA regulations Full Job Description Description 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. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

Position 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 Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process. 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.