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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.