Equipment Development Engineer II - CDM de 24 mois at Medtronic

Lausanne, Vaud, Switzerland

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s or Master’s degree in Mechanical, Electrical, Automation, or related field
Be flexible to travel up to 20% of the time to suppliers, other Medtronic sites, and on-site validation and commissioning activities

Responsibilities

Lead the design and development of specialized manufacturing equipment for medical device fabrication
Define and validate User Requirement Specifications (URS) and ensure alignment with business and manufacturing needs
Establish equipment architecture standards, including hardware, safety, ergonomics, and automation
Collaborate with third-party manufacturers and integrators to oversee the design, customization, and build of equipment
Ensure early integration of MEX principles (Early Equipment Management – EEM) during design phases
Lead the full lifecycle of equipment acquisition projects, from concept and business case development to commissioning and handover
Manage project scope, budget, timelines, and risks to ensure on-time and on-budget delivery
Coordinate with suppliers, contractors, and automation integrators, ensuring compliance with Medtronic quality standards
Drive cross-functional collaboration with Manufacturing, Quality, Regulatory, and Validation teams
Prepare and deliver project updates to stakeholders and leadership
Plan, lead, and approve Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT)
Oversee the execution of qualification protocols (IQ, OQ, PQ) for new equipment
Provide technical leadership during debugging, commissioning, and process validation phases
Ensure equipment meets regulatory, performance, and safety requirements
Define and integrate automation strategies, including PLC programming, robotics, motion control, vision systems, and HMIs
Conduct risk analyses (e.g., eFMEA) to ensure robust equipment performance and safety
Drive process optimization initiatives to improve cycle times, reduce costs, and enhance product quality
Stay current on emerging automation technologies and implement innovative solutions where applicable
Embed MEX methodology into equipment development and acquisition projects
Lead EEM activities to ensure equipment is designed for reliability, maintainability, and performance
Support the development of preventive and predictive maintenance strategies
Drive standardization of best practices across sites and functions
Ensure complete and accurate documentation for all equipment lifecycle stages, including design specifications, validation protocols, and training materials
Guarantee compliance with applicable regulatory requirements, including FDA, ISO 13485, and GMP
Provide technical expertise during internal and external audits

Skills

Equipment Design

Automation Integration

User Requirement Specifications

URS Validation

Project Management

Supplier Management

Early Equipment Management

EEM

Manufacturing Equipment

Medical Devices

Hardware Design

Safety Standards

Ergonomics

Risk Management

Commissioning

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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