Salary
💰 $106,400 - $159,600 per year
About the role
- Responsible for the validation of Design Verification Test Methods for a new Product Development project for complex electro-mechanical medical devices
- Develop and validate electrical system and subsystem test methods; drive automation and reduce variability
- Collaborate cross-functionally with Design Assurance, R&D, clinical, marketing, regulatory to translate design inputs and clinical use conditions into robust test methods
- Design and validate custom test equipment and fixtures; partner with suppliers and test labs
- Design and execute complex test method validation studies; perform data analyses including gage R&R, ANOVA, and Probability of Misclassification
- Lead investigations, refine methods, and ensure compliance with design inputs and international standards
- Partner with extended team members and external test labs to meet project milestones
- Communicate progress and technical issues to project leadership clearly and frequently
- Participate in the design and development of next-generation energy-based therapeutic medical devices (Coronary & Renal Denervation)
- Expected to work onsite a minimum of 4 days per week at Mounds View/Minneapolis and travel up to 10%
Requirements
- Baccalaureate degree in science, technology, engineering, math or related technical field
- Minimum of 4 years of technical experience, or advanced degree with a minimum of 2 years experience
- Knowledge of electrical engineering principles (essential)
- Experience developing/validating electrical system and subsystem test methods
- Experience with test method development, design for six sigma principles, pre-clinical evaluations
- Experience with system requirements development and design control
- Familiarity with application of ISO standards for medical devices (e.g., ISO 13485, ISO 10012, ISO 17025)
- Familiarity with FDA regulations (e.g., FDA 21 CFR Part 820 cGMP)
- Experience in the management of complex data sets and statistical data analysis (gage R&R, ANOVA, Probability of Misclassification)
- Practical knowledge of project management
- Medical Device Industry experience (preferred)
- Ability to effectively manage personal timelines and ensure timely execution of deliverables
- Strong communication skills to distill complex issues for leadership
- Willingness/ability to travel up to 10%
- Must comply with hiring verification (employer participates in the federal E-Verify program)