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Principal Product Engineer

21000LMJ Requisition #

Careers that Change Lives
In this role, you will be responsible for identifying manufacturing technologies, vendors and processes to support the development of implantable combination products (medical device and pharmaceutical combined devices).  As part of the Process Development team, you will work with cross-functional teams to design and procure highly complex, automated equipment to meet the needs of the development program. You will be the key link in bringing new products from prototype manufacturing into high-volume production. Using your expertise in process and equipment design, you will coach, review, and delegate work to lower level professionals to support equipment and process development within the Interventional Vascular & Structural Heart (IVSH) operating unit. 

Engineers create our market-leading portfolio of innovations. Combine the best of your experience with training and mentorship to move forward. If you want a challenging, energizing, rewarding career that changes lives, join us. Help us bring the next generation of life-changing medical technology to patients worldwide.

You can grow your career with us; we hope you’ll consider joining our team! 

A Day in the Life
• Identify technologies that meet the manufacturing needs of new product development programs 
• Define design criteria and author associated documentation including User Requirements Specifications and Equipment Specifications for highly automated equipment
• Oversee vendor design and fabrication of automated manufacturing equipment 
• Lead the definition and execution of the Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ) and process characterization.
• Represent the organization as a primary technical contact for specific projects and initiatives with vendors; communicates with internal and external customers and suppliers at various levels
• Lead efforts for production release of finished goods and components. This includes BOM’s/routings and other ERP required information.  
• Develop solutions to complex problems, and/or makes moderate to significant improvements of processes, systems or product independently to enhance performance of the area
• Manage major/complex projects, involving delegation of work and review of work products, at times acting as a team leader
• Make use of appropriate quality tools, such as DOE, SPC, hypothesis testing, and capability studies; to measure, monitor, improve and control the mfg line and select processes
• Identify process improvement opportunities and provide technical solutions via analysis and hands-on interaction with designated processes
• Utilize project mgmt skills to drive process development, vendor adherence to program schedules, and validation projects to completion; on time and on budget
• Create written documents, test plans and reports that demonstrate technical rationale for associated decisions(s) (e.g. qualifications, risk assessments, and work instructions)
• Work with product development engineering to drive back lessons learned as new products are being developed
• Provide training and certification for trainers as required
• Lead efforts to investigate and develop new technology related to combination products

Must Haves
• Bachelor's Degree and 7+ years of Engineering experience OR advanced Degree and 5+ years of Engineering experience

Nice to Have
• Experience in medical device, pharmaceutical or highly regulated industry
• Experience in the design and specification of highly automated manufacturing equipment 
• Understanding of a wide application of technical principles, theories, and concepts of manufacturing processes including robotics, spraying systems, and laser cutting
• Technical knowledge of high volume and highly complex manufacturing processes
• Experience handling multiple tasks concurrently 
• Work experience with the following: FDA Quality System Regulations, ISO 13485, ISO 9001 standards or equivalent
• Experience with leading/executing process validation activities (installations qualifications, process characterization, operational and performance qualifications)
• Excellent data analysis skills, and proficient in the use of statistical tools in problem solving
• Experience with design of experiments (DOE), process failure mode and effects analysis (PFMEA) and control/monitoring plans
• Excellent technical writing skills

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)

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