Principal Process Development Engineer

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.

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

Responsibilities

• 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 the most efficient and productive layout.
• Feasibility Studies: Perform feasibility studies that explore new process technologies and evaluate their 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 include 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:

• Bachelor’s degree in Engineering, Science, or a technical discipline
• Minimum of 7 years of work experience in Engineering, Science, with 5 years 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.

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.

Equal Employment Opportunity

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.