Manufacturing Engineer (Medical Manufacturing)

Manufacturing Engineer (Medical Manufacturing)

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Manufacturing Engineer (Medical Manufacturing)

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Complete Staffing Solutions provided pay range

This range is provided by Complete Staffing Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$115,000.00 / yr - $115,000.00 / yr

MANUFACTURING ENGINEER (Medical Manufacturing)

Compensation- $110,000-$120,000

Torrington CT

We are seeking a hands-on, results-driven Manufacturing Engineer to support the seamless transition of new products from development into full-scale production within our regulated medical injection molding and assembly facility. This role is critical to driving process excellence, ensuring compliance, and enabling scalable, cost-effective manufacturing. The ideal candidate will combine strong technical expertise with practical project execution skills and a continuous improvement mindset.

Key Responsibilities

• Project Leadership
• Lead manufacturing engineering activities for new product introductions (NPI), from concept through validation and production ramp-up.
• Manage project timelines, deliverables, and risk mitigation strategies to ensure on-time, in-spec, and in-budget launches.
• Process Design & Optimization
• Develop, optimize, and scale injection molding and secondary assembly processes to ensure consistent quality, high efficiency, and cost-effectiveness.
• Apply lean principles, data analytics, and root cause methodologies (5-Whys, Fishbone, etc.) to eliminate waste and reduce variability.
• Tooling & Equipment Management
• Oversee the specification, procurement, and validation of molds, jigs, fixtures, and custom equipment.
• Collaborate with toolroom personnel and external vendors to manage tooling performance, modifications, and preventative maintenance.
• Documentation & Training
• Create and maintain robust documentation including process flow diagrams, work instructions, SOPs, and validation protocols.
• Lead operator training and knowledge transfer for new or revised manufacturing processes.
• Compliance & Validation
• Develop and execute validation protocols (IQ / OQ / PQ) in alignment with FDA, ISO 13485, and GMP requirements.
• Ensure all processes meet regulatory standards and are audit-ready at all times.
• Cross-Functional Collaboration
• Partner with Program Management, Quality, Operations, and Supply Chain to ensure design for manufacturability (DFM), smooth tech transfers, and issue resolution.
• Facilitate manufacturing readiness reviews and support customer communications as needed.
• Continuous Improvement
• Drive Kaizen initiatives, lead root cause investigations, and implement sustainable corrective and preventive actions (CAPA).
• Identify and execute cost reduction and efficiency improvement projects without compromising quality or compliance. Qualifications
• Education :
• Bachelor's degree in Manufacturing, Mechanical, Industrial Engineering, or related discipline.
• Experience :
• 2–5 years of experience in a manufacturing engineering or process development role, preferably in medical device, injection molding, or other regulated industries.
• Technical Proficiency :
• Strong understanding of injection molding processes, mold qualification, and downstream assembly operations (e.g., ultrasonic welding, pad printing, packaging).
• Hands-on experience with tooling design, procurement, and maintenance.
• Proficient in process validation methodologies (IQ / OQ / PQ).
• Skilled in statistical analysis tools (e.g., Minitab, Gainseeker) and process monitoring.
• CAD experience required; simulation tools a plus.
• In-depth knowledge of ISO 13485, ISO 9001, FDA, and GMP standards.
• Soft Skills :
• Strong project management and organizational abilities.
• Excellent problem-solving and analytical thinking.
• Effective communicator across functions and levels.
• Customer-facing experience is a plus.
• High sense of urgency, ownership, and adaptability. Work Environment & Physical Requirements
• Work is performed in both office and production / cleanroom environments.
• Must be able to stand, walk, and interact with manufacturing equipment daily.
• Ability to lift up to 25 lbs.
• Must adhere to cleanroom and safety protocols.

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Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Engineering and Information Technology

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