Principal Test Method Engineer

Principal Test Method Engineer

Requirements

• Bachelor’s degree in Science, Technology, Engineering or Math or related technical field.
• Minimum of 7 years of technical experience, or advanced degree with 5 years of technical experience.
• 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, capital equipment.
• Experience in electrical engineering principles is essential
• Practical knowledge of project management.

Responsibilities

• Responsible for leading the team that is responsible for the validation of Design Verification Test Methods for a new Product Development project for complex electro-mechanical medical devices. Candidate should have experience developing/validating electrical system and subsystem test methods, preferably with an electronic engineering background.
• Work within the Design Assurance team and cross-functionally with R&D, clinical, marketing and regulatory to translate design inputs and clinical use conditions into test methods – meeting all stakeholders’ requirements.
• Support the development and own the validation of test equipment and fixtures, and where required work closely with suppliers to validate equipment to Medtronic requirements. Manage capital equipment procurement and financial tracking for Design Verification equipment. Automate testing and reduce test method variation to ensure robust and appropriate test methods to demonstrate compliance to Design Inputs.
• Lead and successfully complete complex test method validation tasks including operator training, determining appropriate validation study design and sample size, data analysis including crossed gage R&R, ANOVA, Probability of Misclassification, identification and reduction of sources of variation and report writing for system and capital equipment test methods.
• Liaise with extended team members, test lab managers and test operators, to facilitate timely completion of test method validation activities in alignment with the overall project phase and project target milestones.
• Provide technical expertise in test method development, exhibit strong problem-solving skills, support project investigations and lead validation activities in alignment with the overall project phase and project target milestones.
• Communicate progress to project leadership on frequent basis. Be able to distill complex issues into concise and clear messages.
• As part of ongoing professional development, you will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, transfer, and commercialization activities.
• Translate international standards requirements and regulatory guidance into test methods.
• Work independently to plan and schedule the test method team’s and your own activities necessary to meet timelines.

Preferred Qualifications

• 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.