Equipment Development Engineer (2-year contract)

at  Medtronic

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
As an Equipment Development Engineer at Medtronic, you will be at the forefront of developing state-of-the-art manufacturing equipment tailored for medical device production. You will collaborate closely with third-party equipment manufacturers and internal teams to ensure that our production lines meet stringent industry standards and regulatory requirements. This role requires a blend of technical expertise, project management acumen, and a willingness to travel up to 30% of the time to various manufacturing sites and vendor locations.

Key Responsibilities

• Design & Development
• Lead the development of specialized manufacturing equipment for medical device fabrication.
• Collaborate with cross-functional teams to define and develop User Requirement Specifications (URS) for new equipment.
• Partner with third-party manufacturers to oversee the design, production, and customization of equipment.
• Validation & Testing
• Manage and conduct Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) to validate equipment functionality and compliance.
• Develop comprehensive validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Project Management
• Oversee equipment development projects from inception through completion, ensuring that milestones, timelines, and budgets are adhered to.
• Coordinate with suppliers, vendors, and internal stakeholders to ensure the timely delivery and successful integration of new equipment.
• Utilize project management tools to track progress, manage resources, and report on project status.
• Automation & Process Improvement
• Integrate automation solutions into manufacturing processes to enhance efficiency, accuracy, and scalability.
• Continuously identify and implement process improvements to optimize equipment performance and reduce costs.
• Stay informed about the latest advancements in automation technologies and manufacturing best practices.
• Documentation & Compliance
• Maintain detailed and accurate documentation for all equipment development activities, including design modifications, validation reports, and compliance records.
• Ensure that all equipment and associated processes meet regulatory standards, including FDA, ISO 13485, and other applicable regulations.
• Travel Requirements
• Be flexible to travel up to 30% of the time to visit manufacturing sites, third-party vendors, and participate in on-site testing and validation activities.

Qualifications

• Education
• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Automation Engineering, or a related field.
• Experience
• Minimum of 5 years of experience in equipment development or manufacturing engineering within the medical device industry.
• Demonstrated experience with URS, FAT, and SAT processes.
• Technical Skills
• Strong understanding of automation systems, manufacturing processes, and equipment validation.
• Proficiency in project management tools and software.
• Skilled in CAD software (e.g., SolidWorks, AutoCAD) and other engineering design tools.
• Knowledge of regulatory requirements for medical device manufacturing (e.g., FDA, ISO 13485).
• Soft Skills
• Strong leadership and project management abilities.
• Excellent problem-solving skills with a detail-oriented mindset.
• Effective communication and collaboration skills across cross-functional teams.

Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity
her

• Design & Development
• Lead the development of specialized manufacturing equipment for medical device fabrication.
• Collaborate with cross-functional teams to define and develop User Requirement Specifications (URS) for new equipment.
• Partner with third-party manufacturers to oversee the design, production, and customization of equipment.
• Validation & Testing
• Manage and conduct Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) to validate equipment functionality and compliance.
• Develop comprehensive validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Project Management
• Oversee equipment development projects from inception through completion, ensuring that milestones, timelines, and budgets are adhered to.
• Coordinate with suppliers, vendors, and internal stakeholders to ensure the timely delivery and successful integration of new equipment.
• Utilize project management tools to track progress, manage resources, and report on project status.
• Automation & Process Improvement
• Integrate automation solutions into manufacturing processes to enhance efficiency, accuracy, and scalability.
• Continuously identify and implement process improvements to optimize equipment performance and reduce costs.
• Stay informed about the latest advancements in automation technologies and manufacturing best practices.
• Documentation & Compliance
• Maintain detailed and accurate documentation for all equipment development activities, including design modifications, validation reports, and compliance records.
• Ensure that all equipment and associated processes meet regulatory standards, including FDA, ISO 13485, and other applicable regulations.
• Travel Requirements
• Be flexible to travel up to 30% of the time to visit manufacturing sites, third-party vendors, and participate in on-site testing and validation activities