Laser NPI Engineer II

About the company

VitalPath is a trusted contract manufacturing partner that delivers high-quality complex catheter solutions around the world that save lives and restore patient health and vital function. We strive to treat every product we design and manufacture to the highest level of quality and awareness that these products are going to be used inside of a patient, possibly even our own family members. Our employees' impassioned hard work and dedication are at the core of our success. Every function within our organization plays a crucial role in our mission and is deeply valued for its contribution to achieving our shared goals of quality, innovation, continuous improvement, and operational excellence. As a fast-growing organization, we bring harmony and standardization across VitalPath with a strong vision in mind — We are one VitalPath. We embrace our diversity, celebrate each other's success, support one another through change, and continue to grow as a high-performing organization. We aim to shape our corporate culture to enhance team member engagement, skills, and productivity so that VitalPath is an employer of choice.

About the role

The Laser NPI Engineer II plays a key role in transforming new medical device designs into scalable, production-ready laser processes. Combining hands-on laser processing expertise with NPI discipline, this role independently develops laser programs, processes, and tooling for tightly toleranced metal and polymer components; executes qualification and validation; and supports release to manufacturing. The position partners closely with customers, New Product Development, Operations, Quality, Supply Chain, and Sustaining Engineering, and helps customers solve complex manufacturing challenges by demonstrating the value of VitalPath's laser processing capabilities.

Schedule

This position requires the employee to be onsite at our VitalPath Maplewood, MN location with occasional travel to other VitalPath sites such as Cokato, MN. Shift/Schedule: Monday–Thursday 9x4, Friday 4-hour day. VitalPath does not offer relocation assistance for this position. Travel between VitalPath sites as required; occasional travel to customer/vendor facilities.

Responsibilities

• Independently develop laser programs, process parameters, and associated hardware for metals and polymers in flat and round stock to exacting customer blueprint requirements.
• Determine the best laser type and settings for each material and feature requirement (cutting, drilling, welding, coating removal).
• Execute IQ, OQ, PQ, DOE, process characterization, and capability studies to FDA and ISO requirements.
• Develop clear, well-structured validation protocols and reports, manufacturing procedures, and work instructions.
• Plan and execute pilot builds and document results with strong attention to detail.
• Perform statistical analysis using Minitab or similar tools.
• Design or specify fixtures, tooling, and test methods for laser processes.
• Develop cleaning and post-processing steps tied to laser-processed components.
• Participate in DFMEA, PFMEA, and control plan development.
• Integrate with customers to review specifications, assess manufacturability, and draft/review inspection criteria with Quality.
• Evaluate customer requests for quote and provide input on capability, development effort, expected throughput, and yield.
• Troubleshoot laser programming, setup, and equipment issues that impact production.
• Train laser technicians, setup technicians, and operators on new processes.
• Draft MVP documentation and monitor validation progress.
• Lead or support root cause investigations and CAPA activities.
• Work with Purchasing to order components, tools, and equipment; ensure job BOMs are accurate and tooling is ordered on time.
• Maintain and promote laser and team safety and a clean, orderly work area.
• Create and maintain engineering documentation in alignment with VitalPath QMS requirements.
• Perform other engineering duties as assigned.

Requirements

• Bachelor's degree in Mechanical, Manufacturing, Industrial, Biomedical, Materials, or related Engineering field; or Associate degree in laser/photonics manufacturing technology with 5+ years of directly related laser process engineering experience.
• 2–5 years of engineering experience in NPD, manufacturing, validation, or medical device development, including at least 2 years of hands-on laser processing with high-tolerance cutting and drilling of metals and/or polymers.
• Working knowledge of IQ/OQ/PQ, DOE, and statistical analysis.
• Ability to read and understand complex blueprints, with working GD&T knowledge.
• Working knowledge of SolidWorks/AutoCAD and Minitab.
• Familiar with design controls, FDA regulations, ISO 13485, GMP, GDP, and QMS.
• Strong verbal and written communication with internal and external customers.
• Ability to work independently with minimal supervision and manage multiple projects concurrently.
• Good dexterity and hand-eye coordination working with small parts.
• Ability to work with microscopes and sit/stand for extended periods of time.
• Ability to lift up to 50 pounds.
• Must follow laser safety requirements, including use of required PPE.

Preferred Qualifications

• Experience with catheter, wire, or medical subassembly manufacturing.
• Experience with laser welding.
• Experience using laser processing to remove coating from wire and/or braided shafts.
• Six