Manufacturing Engineering Manager

About the role

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.

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.

Requirements

• A Bachelor’s degree in an engineering discipline or a technical equivalent degree.
• Minimum of 7 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.
• Able to meet deadlines and manage projects across multiple departments.
• Able to handle multiple projects and customers simultaneously.

Qualifications

• Good To Have:
• 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).

Skills

• Strong leadership and mentoring skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Technical proficiency in engineering disciplines relevant to the role.

Benefits

Cirtec Medical Corporation provides 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.

Pay

$120,000 - $150,000 annually

Schedule

Full-time