Sr Laser NPI Engineer

VitalPath; Cokato (MN); On-site; USD 115,000 - 128,000; Full time

Benefits offered by this job

Health Insurance

Vision Insurance

401K with company match

Paid Time Off

Holidays

Job summary

VitalPath is seeking a Senior Laser NPI Engineer to lead the transfer of laser-processed medical device components from concept to production. You will drive qualification, validation, and release-to-manufacturing while mentoring engineers and coordinating across New Product Development, Operations, Quality, and Supply Chain.

You will champion laser process standards, safety, and continuous improvement, collaborating with customers and internal teams to optimize design-for-manufacturing and cost

Qualifications

• 8+ years in catheter/medical device development/manufacturing or validation.
• 5+ years hands-on laser process development.
• Expert-level knowledge of high-tolerance laser cutting/drilling of metals and polymers.
• Experience with IQ/OQ/PQ and statistical analysis.
• Knowledge of GD&T, SolidWorks/AutoCAD, and Minitab.
• FDA regulations, ISO 13485, GMP, GDP, and QMS experience.

Responsibilities

• Serve as laser processing SME across VitalPath sites (cutting, drilling, welding, ablation, coating removal).
• Lead laser program development and hardware for complex components.
• Own releaseto-manufacturing within PhaseGate for laser NPI projects.
• Lead pilot builds and scale-up planning (throughput, yield, capacity).
• Coordinate cross-functional project execution including budgets and schedules.

Skills

Laser processing

Statistical analysis

Project management

Leadership

Customer communication

Education

Bachelor’s in Mechanical Engineering

Master’s degree preferred

Tools

SolidWorks

AutoCAD

Minitab

GD&T

Job description

Join VitalPath in Maplewood as a Sr Laser NPI Engineer!

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. If you’re ready to contribute to groundbreaking medical advancements in a collaborative, fast paced environment, we invite you to apply and be part of our growth!

About The Position

The Senior Laser NPI Engineer is a technical leader for bringing new laser-processed medical device components from concept to production. This role leads the qualification, validation, and release-to-manufacturing of complex laser processes; serves as the laser processing subject matter expert for customers and internal teams; and mentors engineers and technicians. The Senior Laser NPI Engineer helps customers solve their most complex manufacturing challenges, shapes VitalPath’s laser capabilities and capital strategy, and bridges New Product Development, Operations, Quality, Supply Chain, and customer engineering teams to drive successful product launches.

Work Location/Schedule

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

Responsibilities

• Serve as subject matter expert for laser processing (cutting, drilling, welding, ablation, coating removal) of metals and polymers across VitalPath sites.
• Lead development of laser programs, processes, and hardware for highly complex, tightly toleranted components.
• Lead IQ, OQ, PQ, DOE, process characterization, and capability studies; develop, review, and approve validation protocols and reports.
• Own and manage the releasetomanufacturing process within PhaseGate for laser NPI projects.
• Lead pilot builds and production scaleup planning, including throughput, yield, and capacity.
• Apply advanced statistical tools to guide engineering decisions.
• Lead DFMEA, PFMEA, and control plan development.
• Collaborate with customers on design, manufacturability, scalability, and specification reviews; represent VitalPath’s laser expertise in customer meetings and technical reviews.
• Lead technical responses to customer requests for quote, including feasibility, development effort, throughput, yield, and cost drivers.
• Oversee development of fixtures, tooling, and validation equipment.
• Lead root cause investigations and CAPA activities.
• Research, justify, and recommend capital laser equipment for the annual budget; lead equipment selection and qualification.
• Establish laser process standards and best practices and drive continuous improvement.
• Mentor and develop engineers and technicians; train manufacturing and engineering teams on new processes and methods.
• Champion laser safety and a clean, orderly work environment.
• Coordinate crossfunctional project execution, including project budgets and schedules.
• Ensure compliance with VitalPath QMS, design controls, ISO 13485, and FDA regulations.
• Perform other engineering duties as assigned.

Required Qualifications

• Bachelor’s degree in Mechanical, Manufacturing, Industrial, Biomedical, Materials Optical, or related Engineering field
• Minimum 8 years of experience in catheter or medical device development, manufacturing, or validation, including 5+ years of handson laser process development
• Expertlevel knowledge of hightolerance laser cutting and drilling of metals and polymers, and of laser types and their applications (e.g., fiber, femto, CO2, UV)
• Strong expertise in IQ/OQ/PQ and statistical analysis
• Excellent working knowledge of GD&T, SolidWorks/AutoCAD, and Minitab
• Experience with design controls, FDA regulations, ISO 13485, GMP, GDP, and QMS
• Demonstrated leadership, project management, and customerfacing communication skills
• 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
• Potential for future direct reports as the role expands

Preferred Qualifications

• Master’s degree in Engineering or related technical field
• Six Sigma Green Belt or Black Belt certification
• Experience with Lean manufacturing
• Experience defining project budgets, schedules, and capital equipment justifications
• Experience with laser welding and laser coating removal from wire and/or braided shafts
• Laser Safety Officer (LSO) certification
• Understanding of machining principles

Compensation Package

• The salary range for this position is $115,000 $128,000 . 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.