Laser NPI Engineer II

VitalPath; Cokato (MN); On-site; USD 94,000 - 105,000; Full time

Benefits offered by this job

Health and dental insurance

Vision insurance

401K with company match

Paid time off

MN Earned Sick & Safe Time

Job summary

VitalPath in Cokato, MN, is seeking a Laser NPI Engineer II to convert new medical device designs into scalable laser processes. You will develop programs, settings, and fixtures for precise metal and polymer parts, executing qualification and validation while collaborating with customers, NPD, Operations, Quality, and Supply Chain.

The role requires hands-on laser processing, DOE knowledge, and experience with GMP/QMS. Expect to work onsite with occasional travel to Maplewood and other sites.

Qualifications

• IQ/OQ/PQ, DOE, and statistical analysis knowledge.
• Ability to read and understand complex blueprints with GD&T knowledge.
• Experience with design controls, FDA regulations, ISO 13485, GMP, GDP, and QMS.

Responsibilities

• Develop laser programs, process parameters, and tooling for metals/polymers to blueprint specs.
• Determine laser types and settings for material features (cutting, drilling, welding).
• Execute IQ, OQ, PQ, DOE, and validation studies per FDA/ ISO requirements.

Skills

Laser processing

Minitab

GD&T

Blueprint interpretation

Education

Bachelor's degree in Mechanical/Manufacturing/Industrial/Biomedical/Materials Engineering

Associate degree in laser/photonics manufacturing technology with 5+ years of related laser process experience

Tools

SolidWorks

AutoCAD

Minitab

Job description

Join VitalPath in Cokato as a Laser NPI Engineer II!

About VitalPath

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 others 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 Position

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.

Work Location/Schedule

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

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, wellstructured 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 postprocessing steps tied to laserprocessed 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.

Required Qualifications

• 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
• 25 years of engineering experience in NPD, manufacturing, validation, or medical device development, including at least 2 years of handson laser processing with hightolerance 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 handeye 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
• Travel between VitalPath sites as required; occasional travel to customer/vendor facilities

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 Sigma or Lean experience
• Experience with test fixture design or process characterization

Compensation Package

• The salary range for this position is $94,000 $105,000 . The posted salary range complies with federal and local regulations and may vary based on factors such as market conditions, level of experience and training, education, certifications, as well as internal and external equity.
• This position is eligible to earn an annual performance bonus based on meeting VitalPath’s bonus performance plan.

Benefits

• Comprehensive, Low Cost Health and Dental Insurance Plans Available
• Vision Insurance
• Health Savings Account with company contribution
• Short and Long Term Disability
• Supplemental insurances (short term disability, AD&D, life insurance, MN paid family & medical leave, and more)
• Parental Leave
• Paid Time Off
• Minnesota Earned Sick & Safe Time
• Paid Holidays
• 401K with company match
• Opportunities for career growth and advancement

VitalPath is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, work related mental or physical disability, veteran status, sexual orientation, gender identity, or genetic information. VitalPath participates in E-Verify.