Senior NPI Engineer

Exalta Group; Shimer (PA); On-site; USD 90,000 - 120,000; Full time

Job summary

Exalta Group in Bethlehem, PA is seeking an NPI Manufacturing Engineer to develop, optimize, and document manufacturing processes for medical devices. You will collaborate with Quality, Production, and Engineering to ensure product consistency and regulatory compliance.

The role requires Lean/Six Sigma expertise, SolidWorks CAD, ERP familiarity, and hands-on experience with process improvement, CAPA investigations, and GMP/QMS. Prolonged standing and lifting 40 lbs are expected.

Qualifications

• 5 years of experience in manufacturing engineering in the medical device industry preferred.
• Bachelor’s degree in Manufacturing, Industrial or Mechanical Engineering or related field.
• Strong knowledge of GMP, ISO 13485 and quality systems in medical device manufacturing.

Responsibilities

• Lead production-support efforts with management to ensure efficient and effective operations.
• Conduct time studies, process flow analyses, and tool life studies to optimize efficiency and labor planning.
• Lead Lean and Six Sigma improvements to enhance safety, quality, productivity, and costs.
• Drive continuous improvement initiatives, including kaizen events and process optimization.
• Design and implement processes, fixtures and tooling to support and optimize manufacturing operations and ensure quality alignment.
• Collaborate across departments and sites to standardize processes and share best practices.
• Provide expert technical support for troubleshooting, root cause analyses, NC investigations and CAPA processes.
• Create and update SWIs, SOPs, BOOs, BOMs, and CCs, reflecting evolving production needs.
• Support training programs and on-the-floor guidance.
• Ensure adherence to Tyber Medical Safety, OSHA, cGMP, GDP and QMS requirements.
• Other duties as assigned.

Skills

Lean manufacturing

Six Sigma

Root cause analysis

MS Office

CAPA investigations

Education

Bachelor’s degree in Manufacturing Engineering

5 years of experience in manufacturing engineering (medical device)

Tools

SolidWorks CAD

ERP systems

3D Printing

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Regular Full-Time Bethlehem, PA, US

Job Title: NPIManufacturing Engineer

Position Summary: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.

• 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.

Experience / Core Competencies:

• 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.

Required / Preferred Education

• High School Diploma, GED or equivalent required.
• Bachelor’s degree in Manufacturing Engineering, Industrial Engineering, Mechanical Engineering, or related field required.
• 5 years of experience in manufacturing engineering role within the medical device industry preferred.