Quality Engineer II - Process Validation

Medtronic; United States; Remote; USD 70,000 - 90,000; Full time

Job summary

A leading healthcare technology company is seeking a Process Validation Engineer to support the lifecycle of products. The role involves collaborating with engineering and manufacturing teams to ensure quality standards, authoring protocols and reports, and supporting process changes. Ideal candidates should possess a bachelor's degree in Engineering or Science along with relevant experience in quality assurance within the medical devices sector.

Benefits

Flexible Benefits Package

Short-term incentive plan

Qualifications

• 2-3 years of experience in Quality or Medical Devices.
• Strong risk-based approach to problem-solving.
• Ability to work independently and as part of a team.

Responsibilities

• Provide process validation input as part of a cross-functional team.
• Author and support qualification/validation protocols and reports.
• Assess the impact on process validation for changes in manufacturing.

Skills

Problem-solving

Communication

Organisational skills

Presentation skills

Teamwork

Education

Level 8 bachelor's degree in Engineering or Science

Tools

Agile MAP

Statistical analysis

Equipment development

Job description

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

Medtronic

At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations.

Our Purpose

At our Process Validation Department in Medtronic, plc, we focus on providing process validation support throughout the full lifecycle of the product. From initial development of new products to ongoing support when products have been commercialised, we ensure that the performance and safety of the devices we support is maintained through the product lifecycle.

Come for a job, stay for a career!

A Day in The Life Of:

Responsibilities may include the following and other duties may be assigned:

• As part of a cross-functional team, provide process validation input through collaboration with engineering and manufacturing functions to ensure quality standards are in place for commercially manufactured products.
• Author and support (input and critical review) of qualification/validation protocols/reports, performing statistical analysis to ensure products meet the required standards and specifications.
• Support the introduction/implementation of process/materials changes to the manufacturing operation. Assess the impact on process validation for these changes.
• Provide on-going communication, information transfer and record keeping in support of business and core-team objectives and metrics.

Key Skills & Experience

• Level 8 bachelor’s degree in Engineering or Science and desirably with 2-3 years of experience in Quality or Medical Devices.
• You are technically orientated with a strong risk-based approach to problem-solving.
• Established and productive individual contributor.
• You can work independently under general supervision on larger, moderately complex projects/assignments.
• You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams with a high level of enthusiasm and motivation.
• Strong communication, organisational and presentation skills are desirable.
• Excellent problem-solving skills are desirable.
• Experience with Agile MAP, statistical analysis, equipment development an advantage.
• You are a good communicator and fluent in English, both verbal and written.

Medtronic offer a competitive salary and flexible Benefits Package

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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.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). 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 95,000+ 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 here