Senior NPI Engineer

Exalta Group•Bethlehem, PA

About The Position

Under the direction of a supervisor, performs a variety of tasks and operations that are required to support and execute the production of medical devices. This role focuses on developing, optimizing, and documenting manufacturing processes while supporting a collaborative production environment. This position will also work closely with Quality, Production, Manufacturing, and Engineering teams to ensure product consistency and regulatory compliance. Adherence to established Standard Work Instructions (SWI’s), Standard Operating Procedures (SOP’s), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Quality Management System (QMS) is essential.

Requirements

Expertise in primary manufacturing processes, fixture design, and tooling development, with a strong track record of optimizing production processes.
Extensive experience in supporting and improving a production environment, with a deep understanding of the operational requirements.
Advanced proficiency in SolidWorks CAD software for designing, modeling, and creating detailed technical drawings and simulations.
Proficient in operating and troubleshooting 3D Printing equipment and software.
Advanced proficiency with Microsoft Office applications.
Advanced proficiency with industrial engineering practices, including time studies, lean manufacturing techniques, and continuous improvement methodologies (LEAN/Six Sigma).
Strong ability to create, review, and update SWI’s, SOP’s, CC’s, and visual aids.
Strong ability to perform Non-Conformance investigations and CAPA root cause analysis.
Strong familiarity with FDA regulations, ISO 13485 standards, and other quality control practices relevant to medical device manufacturing.
Expertise with ERP systems and job traveler execution.
Strong analytical and problem-solving skills, with the ability to tackle complex engineering challenges.
Proven leadership in establishing and maintaining effective working relationships across teams and departments.
Demonstrated ability to work independently with a strong sense of urgency, and effectively under pressure.
Excellent written and oral communication skills.
Ability to stand for prolonged periods of time.
Ability to lift a minimum of 40 lbs.
High School Diploma, GED or equivalent required.
Bachelor’s degree in Manufacturing Engineering, Industrial Engineering, Mechanical Engineering, or related field required.

Nice To Haves

5 years of experience in manufacturing engineering role within the medical device industry preferred.

Responsibilities

Leads efforts to support production needs by working closely with management, ensuring efficient and effective operations.
Oversee and conduct time studies, process flow analyses, and tool life studies to optimize efficiency, reduce cycle times, and support labor planning.
Lead and mentor the application of Lean and Six Sigma methodologies to drive improvements in safety, quality, productivity, and cost efficiency.
Champion continuous improvement initiatives, including kaizen events and process optimization.
Design and implement processes, fixtures and tooling to support and optimize manufacturing operations, ensuring ergonomic and efficient use in production and adherence to quality standards.
Collaborate across departments and sites to ensure alignment and best practices in process standardization and continuous improvements across the organization.
Provide expert technical support in troubleshooting manufacturing issues, conducting root cause analysis, and managing Non-Conformance (NC) investigations and CAPA (Corrective and Preventive Actions) processes.
Create and maintain key function documents, including SWI’s, SOP’s, BOO’s, BOM’s, and CC’s, ensuring they are updated in response to evolving production needs.
Support training programs and on-the-floor support.
Ensure strict adherence to Tyber Medical Safety and OSHA requirements.
Ensure compliance with current Good Manufacturing Practices (cGMP), Standard Work Instructions (SWI’s), Standard Operating Procedures (SOP’s), Good Documentation Practices (GDP), Quality Management System (QMS).
Other duties as assigned.