Senior Medical Device Manufacturing Technician (On-Site)

Olympus Corporation of the Americas; Brooklyn Park (MN); On-site; USD 90,231,000 - 121,809,000; Full time

Benefits offered by this job

Competitive salaries, annual bonus and

401(k) with company match

24/7 Employee Assistance Program

Paid Vacation and Sick Time

Parental Leave and Adoption Assistance

12 Paid Holidays

On-Site Child Daycare, Café, Fitness

Job summary

Olympus Corporation of the Americas seeks a Senior Engineering Technician II to support the installation, maintenance, and continuous improvement of manufacturing equipment and processes in an ISO 13485 environment.

You will design, build, test, and maintain fixtures, tooling, and prototypes, and collaborate with Manufacturing Engineering, Quality, Operations and R&D to enhance quality and efficiency across production lines.

Qualifications

• High school degree required or equivalent.
• 2-year degree or technical certification and minimum of 8 years of related experience.
• Strong technical writing skills.
• Good manual dexterity and the ability to operate electromechanical measurement/test equipment and prototype tool/fixtures.
• Ability to research, design and/or recommend electromechanical measurement/test equipment and prototype tool/fixtures.
• Ability to create, read and properly interpret engineering drawings and take technical instruction from co-workers, supervisors and other professional personnel.
• Ability to plan, schedule, train, recommend and direct peers and subordinate technical personnel in testing, assembly, repair and analysis of medical devices.
• Ability to manage outside services to the lab and to coordinate equipment calibration efforts.
• Ability to model and perform simple design work in SolidWorks required.
• Ability to perform statistical analysis and interpret data in reports.
• Proven problem-solving skills.
• Familiarity with key manufacturing processes such as plastic part design and machining metals and plastics.

Responsibilities

• Support manufacturing equipment installation, qualification, troubleshooting, maintenance and continuous improvement.
• Supports the executiong of engineering projects and continuous improvement initiatives that drive improvements in safety, quality, delivery, and manufacturing efficiency.
• Develop, maintain, and revise manufacturing, validation, and engineering documentation, including work instructions, protocols, reports, procedures, and equipment records in compliance with ISO 13485 and applicable regulatory requirements.
• Execute, document, and report on equipment, process, fixture, and manufacturing-related testing activities.
• Document test methods, inspection methods, and process verification activities with minimal engineering guidance.
• Execute equipment qualifications, process validations, test method validations, and Gage R&R studies, documenting results and recommendations.
• Design, build, modify, and maintain manufacturing tooling, test fixtures, assembly fixtures, and prototype components to support manufacturing and engineering activities.
• Support process transfers, equipment implementations, and manufacturing readiness activities.
• Collect, analyze, and interpret manufacturing, quality, and test data using appropriate statistical methods, and prepare reports that support engineering and operational decision-making.
• Assist in identifying root causes of manufacturing, equipment, and process issues and participate in corrective and preventive action activities.
• Train production personnel, technicians, and other team members on equipment operation, manufacturing processes, fixtures, test methods, and standard work procedures.
• Coordinate activities of technicians, interns, co-op students, and temporary resources supporting engineering and manufacturing projects.
• Collaborate with cross-functional teams including Manufacturing Engineering, Quality, Operations, Maintenance, and R&D to implement process improvements and resolve technical issues.
• Coordinate with vendors, contractors, and external service providers to support equipment maintenance, repairs, upgrades, procurement activities, and process improvements.
• Read, interpret, and create engineering drawings, work instructions, equipment documentation, and fixture designs.
• Create and modify CAD models, fixture designs, and tooling concepts, and work with internal or external resources to fabricate and implement solutions.
• Procure materials, components, tooling, and equipment required to support manufacturing, validation, testing, and improvement activities.
• Perform measurements, inspections, and evaluations of products, components, tooling, and equipment to support manufacturing and quality objectives.
• Support laboratory and manufacturing infrastructure activities, including equipment calibration, preventive maintenance coordination, asset management, safety compliance, facility organization, cleaning services, and hazardous waste handling and disposal.
• Maintain compliance with company policies, quality system requirements, regulatory standards, and Environmental Health and Safety procedures.
• Perform other duties as assigned or self-initiated based on business needs and continuous improvement opportunities.

Skills

Strong technical writing

Statistical analysis

SolidWorks

Reading engineering drawings

Project coordination

Education

2-year degree or technical certification

High school degree or equivalent

Tools

SolidWorks

Electromechanical measurement equipment

Job description

Olympus Corporation of the Americas seeks a Senior Engineering Technician II to support the installation, maintenance, and continuous improvement of manufacturing equipment and processes in an ISO 13485 environment.

You will design, build, test, and maintain fixtures, tooling, and prototypes, and collaborate with Manufacturing Engineering, Quality, Operations and R&D to enhance quality and efficiency across production lines.