Job Description
Now Hiring: Manufacturing Engineering Manager – Medical Devices
Location: Trenton, Ontario
Position Type: Direct Hire
Salary Range: $115,000 – $130,000
We are actively seeking a Manufacturing Engineering Manager – Medical Devices for a direct hire opportunity with our client in Trenton, Ontario . This leadership position offers a competitive salary and the chance to lead a high-performing team within a regulated, ISO 13485-certified medical device manufacturing environment.
Position Overview
The Manufacturing Engineering Manager – Medical Devices is a key leadership role responsible for overseeing the Manufacturing Engineering and Technical Services teams. This individual will drive continuous improvement, support production operations, and ensure full compliance with medical device regulations and quality standards, including ISO 13485.
This role requires prior experience in medical device manufacturing , with a deep understanding of regulatory environments and engineering best practices. Your technical leadership and ability to align engineering initiatives with business objectives will be central to your success.
Key Responsibilities
Lead and manage a team of engineers and technical staff within a medical device manufacturing setting.
Champion Lean, Six Sigma, 5S, FMEA, DFMEA, and other methodologies to improve efficiency, reduce waste, and enhance product quality.
Provide engineering oversight and leadership for new product introductions (NPIs), from concept through full-scale production.
Define and implement departmental goals aligned with company objectives, focusing on quality, performance, and team development.
Establish and maintain engineering policies, procedures, and documentation in compliance with ISO 13485 and other regulatory standards.
Collaborate with Quality, Production, and R&D teams to resolve technical challenges and address non-conformances and customer complaints.
Participate in project planning phases, including budgeting, scheduling, and ROI evaluations.
Mentor and develop engineering team members, supporting their professional growth.
Ensure effective communication and coordination across internal teams and with external partners.
Required Qualifications
Bachelor's degree in Mechanical Engineering, Mechatronics, or a related discipline.
Minimum 5 years of experience managing engineering teams within the medical device industry.
Hands-on experience with ISO 13485 and regulatory compliance in medical manufacturing is required.
Expertise in plastics processing technologies such as extrusion, injection molding, over-molding, and automation.
Proficiency in Process FMEA, validation (IQ/OQ/PQ), and process improvement techniques.
Strong mechanical aptitude and analytical problem-solving capabilities.
Ability to thrive in a dynamic, regulated manufacturing environment with multiple priorities.
Excellent leadership, interpersonal, and communication skills.
Six Sigma Black Belt certification is a strong asset.
This is a unique opportunity to make a significant impact in a growing company at the forefront of medical device manufacturing. If you meet the qualifications and are ready to lead with purpose and precision, we want to hear from you.
Apply now to join a team committed to innovation, quality, and advancing healthcare.
Presented by TriMech Staff Augmentation
TriMech Staff Augmentation is a specialized engineering staffing partner connecting top-tier technical talent with leading organizations. With a deep understanding of engineering disciplines and industry needs, we provide tailored recruiting solutions—including direct hire and contract placements—to ensure the right fit for both candidates and clients.
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TriMech Services specializes in the placement of qualified technical candidates for both temporary and direct hire opportunities. TriMech Services offers a unique approach to matching the specialized skill sets of our candidates specific industries.
TriMech Services specializes in the placement of qualified technical candidates for both temporary and direct hire opportunities. TriMech Services offers a unique approach to matching the specialized skill sets of our candidates specific industries.
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