Manufacturing Project Enginner at Aptyx

Torrington, Connecticut, United States -

Full Time

Start Date

Immediate

Expiry Date

07 Feb, 26

Salary

0.0

Posted On

09 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Manufacturing Engineering, Project Management, Injection Molding, Process Validation, Lean Principles, Data Analytics, Root Cause Analysis, Tooling Management, Cross-Functional Collaboration, Continuous Improvement, Problem Solving, Documentation, Training, Regulatory Compliance, Statistical Analysis, CAD

Industry

Manufacturing

Description

We are seeking a hands-on, results-driven Manufacturing Project Engineer to support the seamless transition of new products and equipment 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, a continuous improvement mindset, and the ability to manage product and equipment transfers, validations, work instructions, and machine setup. Key Responsibilities Project Leadership & Equipment Integration Lead or support manufacturing engineering activities for new product introductions (NPI) and equipment integrations, 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. Plan and coordinate the transfer of existing machines or installation of new equipment into the facility, ensuring proper setup, qualification, and documentation. Coordinate cross-functional teams to ensure design for manufacturability (DFM) and smooth technology or equipment transfers. Partner with Program Management, Quality, Operations, and Supply Chain to ensure process readiness and effective issue resolution. Facilitate manufacturing readiness reviews and support customer communications as needed. 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. Identify and execute cost reduction and efficiency improvement projects without compromising quality or compliance. Tooling & Equipment Management Oversee the specification, procurement, transfer, setup, and validation of molds, jigs, fixtures, and custom equipment. Lead the installation and qualification of new or relocated machines and automation equipment to support production readiness. Collaborate with toolroom personnel and external vendors to manage tooling performance, modifications, and preventative maintenance. Support mold qualification and maintenance activities to ensure sustained performance and reliability. 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. Ensure all documentation is accurate, current, and compliant with regulatory and quality system requirements. Compliance & Validation Develop and execute process validation protocols (IQ/OQ/PQ) in alignment with FDA, ISO 13485, and GMP requirements. Ensure all processes meet regulatory and quality standards and are audit-ready at all times. Maintain alignment with ISO 9001, internal quality systems, and customer-specific requirements. Cross-Functional Collaboration Partner with Program Management, Quality, Operations, Supply Chain, and Tooling to ensure smooth product launches, equipment transfers, and process readiness. Collaborate with cross-functional teams during design reviews, DFM assessments, and risk analyses. Support customer communications and technical discussions related to manufacturability, validation, and production readiness. Continuous Improvement Drive Kaizen and continuous improvement initiatives across production and engineering functions. Lead root cause investigations and implement sustainable Corrective and Preventive Actions (CAPA). Utilize statistical tools and data-driven decision-making to improve process capability and reduce scrap. Contribute to a culture of accountability, problem-solving, and innovation. Qualifications Education Bachelor's degree in Manufacturing, Mechanical, Industrial, or related Engineering discipline. Experience 3-7 years of experience in manufacturing engineering or process development, preferably in medical device injection molding or other regulated industries. Technical Proficiency Strong understanding of injection molding, mold qualification, and downstream assembly operations (e.g., ultrasonic welding, pad printing, packaging). Hands-on experience with tooling design, equipment procurement, machine setup, transfers, and maintenance. Proficient in process validation methodologies (IQ/OQ/PQ) and statistical analysis tools (Minitab, Gainseeker). Skilled in process monitoring, data analytics, and root cause problem solving. 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 a plus. High sense of urgency, ownership, and adaptability in a fast-paced environment. Work Environment & Physical Requirements Work 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. Travel: Up to 30% domestic travel for equipment transfers, validations, and site support.

Responsibilities

The Manufacturing Project Engineer will lead manufacturing engineering activities for new product introductions and equipment integrations, ensuring on-time and compliant launches. This role involves optimizing injection molding processes and managing tooling and equipment to support production readiness.