Manufacturing Engineer

Aptyx • Torrington, CT • 2d ago

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.

Aptyx

Go to Apply

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