Principal Test Method Engineer

Medtronic•Mounds View, MN

10d•$132,000 - $198,000•Hybrid

About The Position

Medtronic is seeking a Principal Test Method Engineer within the Intervention Cardiology Therapy (ICT) Operating unit focusing on Renal Denervation (RDN). This role will be part of the Design Assurance team and will increase product development process rigor to ensure robust understanding of designs, documentation of compliance to requirements and timely, high-quality product launches that satisfy patient needs and reduce customer complaint rates. This role will have primary focus and responsibility for the validation of design verification test methods for complex electro-mechanical medical devices. This position is based at our Mounds View, MN facility and follows a hybrid work model requiring a minimum of 4 days per week on-site for in-person collaboration. This role may require up to 10% travel to support business objectives, in-person meetings and project activities.

Requirements

Bachelor's degree in science, technology, engineering, math or related technical field with a minimum of 7 years of technical experience OR Advanced degree in science, technology, engineering, math or related technical field with a minimum of 5 years of technical experience
Measurement System Analysis (MSA) and Design of Experiment (DOE) experience

Nice To Haves

Experience in engineering development with extensive engineering knowledge and skills in some or all of the following: test method development, design for six sigma principles, pre-clinical evaluations, system requirements development, design control, application of ISO standards for medical devices, equipment, process/equipment validation, capital equipment
Knowledge in electrical engineering principles
Project management experience
Medical Device industry experience
Familiarity with these regulations: FDA 21 CFR Part 820 cGMP, ISO 13485, ISO 10012, and ISO 17025
Experience in the management of complex data sets and statistical data analysis
Ability to manage project timelines to execute deliverables in a timely manner

Responsibilities

Lead the team responsible for the validation of Design Verification Test Methods for a new Product Development project for complex electro-mechanical medical device
Collaborate cross-functionally with stakeholders (e.g. R&D, clinical, marketing and regulatory) to translate design inputs and real-world clinical use conditions into robust reliable test methods; Drive automation and reduce variability to deliver best-in-class test methods
Develop and validate custom test equipment and fixtures, partnering with suppliers where needed
Manage capital equipment procurement and financial tracking for equipment and validation activities
Lead and contribute to complex test method validation activities - designing studies, executing with precision, and performing data analyses (including gage R&R, ANOVA, and Probability of Misclassification); Lead investigations, refine methods, and ensure compliance with design inputs and international standards
Work through extended team members and partner with test labs to facilitate timely completion of test method validation activities in alignment with the overall project phase and project target milestones
Communicate progress to project leadership on frequent basis; Distill complex issues into a concise and clear message