Principal Process Development Engineer at Medtronic in Plymouth, Minnesota

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
Principal Process Development Engineer

Careers that Change Lives

At Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

The Principal Process Development Engineer will lead the development of manufacturing processes for new products for the Peripheral Vascular Health (PVH) business. This position will work with other functions within the program team; but will have ownership for plans, reports, data collection, or other means necessary to gain the knowledge required to create and document the associated manufacturing procedures. You will also collaborate with design colleagues to ensure designs are capable of meeting performance and manufacturing targets. This position will support in data collection and review of regulatory submission-ready documentation for the FDA and other regulatory bodies.

The PVH operating unit offers a diverse portfolio of devices and therapies to treat restore the right blood flow to the right patient.

Peripheral Vascular Health therapies treat patients with Peripheral and Carotid Artery Disease, End-Stage Renal Disease, Superficial and Deep Venous Diseases, and a variety of conditions treated with Peripheral Embolization. The operating unit leads the way in the Superficial Venous, Deep Venous Stenting, and Drug-Coated Balloon markets, caring for nearly 1 million patients globally with lifesaving and life-enhancing therapies.

This position is in Plymouth, MN. within the Peripheral Vascular Health (PVH) operating unit and requires on-site presence.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result -and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.
A Day in the Life

In general, the following responsibilities apply for the Principal Process Development Engineer. This includes, but is not limited to the following:

• Support new product development by designing and developing manufacturing processes for new products that facilitate ease of manufacturing while producing quality, cost effective products with optimized yields.


• Pilot Line Development: Design manufacturing sequence of operations/workflow and specifications for equipment/tooling to ensure most efficient and productive layout.


• Feasibility Studies: Perform feasibility studies that explore new process technologies and evaluate its potential for application to catheter manufacturing. Analyze results and make recommendations.


• Equipment and Fixture Development: Identify equipment and fixture needs within pilot line and/or manufacturing operations. Design and develop equipment and fixture requirements and its process parameters where applicable. Work with suppliers and internal stakeholders to realize design and ensure it meets specified requirements.


• Qualification and Validation: Generate and execute plans for equipment qualification and process validation. Develop plans to evaluate process capability. Perform test method development and validation. Apply six sigma methodologies as appropriate.


• Defines and generates all required documentation in support of manufacturing products and processes. These includes designing and writing engineering protocols in compliance with GMPs and internal procedures, FMECAs, reports, manufacturing instructions and procedures. Use of appropriate six sigma methodologies such as Design of Experiments (DOEs), Gage R&R, and other statistical tools as necessary. Provides in depth analysis of issues or problems and implements process improvements to enhance performance of the job area.


• Collaborates with product development teams to support new product development or existing product line extensions/modifications by ensuring new products or manufacturing processes are designed to facilitate ease of manufacturing and to produce quality, cost effective products with optimized yields. Communicates with senior internal groups and frequent interaction with external groups (i.e. vendors, suppliers, etc.).


• Develops cost benefit analyses and implements process improvements initiatives to reduce and/or optimize product costs.


• Domestic and international travel anticipated up to 25%.

Qualifications

MUST HAVE - MINIMUM REQUIREMENTS:

TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME

• Bachelor's degree in Engineering, Science, or a technical discipline


• Minimum of 7 years of work experience in Engineering, Science, with 5years of managerial experience, OR Advanced degree in Engineering, Science or technical discipline with 5 years of managerial experience

Nice to Have

• Experience in medical device manufacturing or manufacturing in highly regulated industry/environment


• Prior knowledge and experience in new product development


• Working knowledge of statistical tools such as DOE, SPC, Hypothesis Testing and Process Capability Studies


• Experience with polymer extrusion, thermal bonding, adhesive bonding or laser processing


• Six Sigma training and/or certification

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

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 specific to each role. (ADA-United States of America)

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 specific to each role.

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.

Salary ranges for U.S (excl. PR) locations (USD):123,200.00 - 184,800.00

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Medtronic benefits and compensation plans

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 here .

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

At Medtronic, most positions are posted on our career site for 3-7 days.