Manufacturing Engineer

Laborie Medical Technologies Corp; Plymouth (MN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Paid time off

Medical, Dental, Vision

Health Savings Account

401k with company match

Parental Leave

Job summary

Laborie Medical Technologies Corp in Minnesota is seeking a Manufacturing Engineer to support process development, validation, and integration of medical device manufacturing. You will design, qualify, and optimize production lines for catheter balloon components, ensuring quality and efficiency in a controlled environment.

The role requires hands-on engineering experience, ability to travel up to 25%, and collaboration with vendors and operators to reduce defects and improve processes in a

Qualifications

• Bachelor’s degree and 5+ years in Manufacturing Process Engineering.
• Experience with statistical analysis methods for process development; Minitab preferred.
• Experience in chemical and process engineering.
• SolidWorks proficiency.
• Ability to travel up to 25%.
• Preferred catheter/balloon catheter experience; ISO 13485/ISO 9000; IQ/OQ/PQ experience; Six Sigma certification.

Responsibilities

• Evaluate and develop manufacturing processes; confer with vendors; observe operators.
• Oversee manufacturing process of catheter balloon components; tests and validation.
• Install and qualify manufacturing equipment including injection molding and balloon tooling.
• Plan and execute IQ/OQ/PQ; draft protocols/reports; perform PFMEA.
• Improve efficiency by analyzing workflow, space needs and layouts using statistics.
• Design and implement manufacturing fixtures and equipment.
• Support supervisor with production cost estimates and schedules.

Skills

Statistical analysis

Minitab

SolidWorks

Process engineering

Project planning

Education

Bachelor’s degree in Biomedical, Mechanical or Industrial engineering

Tools

Injection molding equipment

PFMEA / quality tools

Job description

We believe that great healthcare is an essential safeguard of human dignity.

At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.

We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.

Who We’re Looking For:

As a key member of the Operations team, the Manufacturing Engineer will support process development, validation, and integration of medical device manufacturing. Work will focus on process development, control, test methods, transition from bench/pilot to full scale manufacturing. Responsible for production, improving quality, reducing defects, and handling non-conforming materials and will play key role in new production line validation and implementation in a controlled work environment.

About the Role:

• Evaluate and develop manufacturing processes, design and conduct research programs; apply knowledge of product design, fabrication, assembly, tooling and materials; conferring with equipment vendors; soliciting observations from operators.
• Responsible for manufacturing process of high-pressure catheter balloons using pleat and fold processes, testing via vacuum leak and high-pressure testing.
• Responsible for installation and qualification of all manufacturing equipment including injection molding equipment and balloon catheter pleat/fold equipment.
• Plan, document and execute process development and process validations including IQ/OQ/PQ, drafting protocol/reports, risk management (PFMEA), and statistical data analysis.
• Improve manufacturing efficiency by analyzing and planning workflow, space requirements and equipment layouts using statistical methods.
• Design and implement manufacturing fixtures and equipment.
• Support Manufacturing Supervisor by providing manufacturing decision-making information; calculating production, labor and material costs; reviews production schedules; estimates future requirements.

Minimum Qualifications:

• Bachelor’s degree in Biomedical, Mechanical or Industrial engineering, or equivalent, plus 5+ years of experience as a Manufacturing Process Engineer, preferably in Medical Devices
• Experience using statistical analysis methods for process development and control, Minitab experience preferred
• Proven experience in chemical and process engineering
• Working knowledge of process engineering software such as SolidWorks
• Ability to travel up to 25%

Preferred Qualifications:

• Catheter/balloon catheter experience
• Injection molding experience
• Experience in Lean Manufacturing – Six Sigma certification
• Experience in ISO 13485/ISO 9000
• IQ/OQ/PQ experience

Why Laborie:

Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.

• Paid time off and paid volunteer time
• Medical, Dental, Vision and Flexible Spending Account
• Health Savings Account with Company Funded Contributions
• 401k Retirement Plan with Company Match
• Parental Leave and Adoption Services
• Health and Wellness Programs and Events

Laborieprovidesequal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.