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

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

About Danvers: Danvers is Medtronic's trusted partner for the development and scaling of cutting-edge delivery systems. We transform concepts into unparalleled performance, enabling Medtronic to serve more patients worldwide. We are currently seeking a Process Development Engineer II to join our team and contribute to our mission.

Role Overview: Be part of a dynamic team that designs and develops manufacturing processes for new delivery systems, from concept through design transfer to product launch. The Danvers process development team is dedicated to revolutionizing the way we manufacture delivery systems, ensuring high-quality products for our patients and customers.

Key Responsibilities:

Process Technologies: Lead the exploration and development of new process technologies for incorporation into new product development projects or existing manufacturing lines. Provide in-depth analysis and recommendations for process improvements.

Process Development: Design and develop manufacturing processes for new products that facilitate ease of manufacturing while ensuring quality, cost-effectiveness, and optimized yields. Activities include:

Manufacturing Studies: Collaborate with the engineering team on studies to characterize process inputs and drive the development of critical manufacturing/process specifications. Utilize statistical support and Design of Experiments (DOE) techniques.

Equipment and Fixture Development: Identify equipment and fixture needs within pilot lines and/or manufacturing operations.

Documentation: Generate required documentation in support of manufacturing products and processes, including engineering protocols/reports, PFMEAs, and manufacturing instructions. Ensure compliance with internal procedures, GMP, and regulations.

Qualification and Validation: Develop and execute plans for equipment qualification and process validation. Lead test method development and validation as needed.

The ideal candidate is knowledgeable and passionate about advanced manufacturing and the development of manufacturing processes during product development phases. This is a fully onsite position at our Danvers, MA location.

Must Have: Minimum Requirements

• Bachelor’s degree in Engineering or a related field

• Minimum of 2 years of relevant experience, or an advanced degree with a minimum of 0 years of relevant experience

Nice to Have:

• Previous medical device experience

• Strong interpersonal skills and the ability to work in a cross-functional team environment

• Solid understanding of statistical techniques and analysis

• Experience with Design for Reliability and Manufacturability (DRM)

• Proficiency in computer skills such as Minitab, Excel, Word, and Project

• Experience with Process Validation (IQ/OQ/PQ) and Test Method Validation

Join us in our mission to transform healthcare and make a difference in the lives of patients worldwide. Apply today to become a part of our innovative team!

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. 

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specifi