Instrument Verification Lead
You would be joining our Instrument Center of Excellence as a Verification Lead (Principal R&D Engineer) responsible for organizing and leading the Surgical Robotic Instrument R&D team to drive meaningful product requirements, an efficient and effective verification strategy, and completion of verification testing and documentation for a variety of NPD and RPE projects. The products this role focuses on verification of are the mechanical surgical instruments (shears, graspers, needle drivers) and accessories that interface with the Hugo™ RAS system.
To us, verification is not just the last step on the path to commercialization; this role is an integral team member throughout all phases of the project. Along the path to launch, you will be a technical contributor towards the success of the product, establishing best-practices and innovative approaches towards proving that our products meet the expectations of the Medtronic Mission. This role is intended to be very collaborative where you will work with the mechanical engineering team to ensure they are aligned on what success looks like for verification activities they are assigned (such as test plans, confidence levels, sample sizes, test methods, test method validations, and documentation methods) and set them up to independently deliver those solutions.
You Will
Working on the Medtronic Campus in North Haven, CT, the Verification Lead will identify and organize work to be performed and then collaborate with the R&D team consisting of Instrument CoE Mechanical Engineering (ME), Systems, Robotic Platforms Product Development Organization (PDO), Robotics Instrument Testing (RIT), Released Product Engineering (RPE), Reliability, Compliance, and Software to accomplish activities in the following areas:
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Requirements
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Responsible for wristed instrument and accessories subsystem requirements (SSR) and design outputs tracking.
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Partner with System Engineering to optimize, create, develop, review, derate, and decompose subsystem requirements.
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Maintain SSR linkages to system requirements, Hardware Items, Test Methods, Body of Evidence, design outputs, etc.
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Verification Plan / Strategy
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Collaborate on change impact assessments (IA) and develop verification strategies/project plans based on the IA output.
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Be an expert in how the surgical robotic instruments work and determine how changes affect the verification plan for that project.
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Define the strategy for instrument subsystem verification, working with the ME and PDO teams to ensure the best verification approach, and collaborate with the ME and RIT teams to achieve the project's verification goals.
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Work with the ME, sourcing, and operations teams to acquire sufficient components and devices prior to testing.
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Test Methods and Validations
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Work with the ME team to identify requirements that need new or updated test methods, align on an approach, support the ME team's execution of test method and fixture development and validation.
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Review and provide feedback on test methods (TM), test method validation (TMV) protocols, and TMV reports.
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Total Body of Evidence (TBOE)
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Identify requirements that need new or updated Body of Evidence (BOE) collected and collaborate with the ME and RIT teams for them to execute that collection and documentation.
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Champion studies and/or activities that drive robust design, such as design of experiments, transfer function development, and simulations.
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Collaborate with Global Lab Services (GLS) to align on approaches to provide evidence supporting of biocompatibility, cleanability, sterility, disinfection, and stability.
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Author or review and provide feedback on engineering reports.
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Tie a variety of evidence to the appropriate requirements. Lead TBOE scoring efforts.
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Design Verification
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Author or review and provide feedback on design verification protocols and reports.
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Author verification summary report.
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Create and maintain instrument subsystem trace matrices.
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Failure Analysis
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Troubleshoot or work with the ME team to troubleshoot failures and make recommendations on design, test, or requirement improvements.
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Author or review and provide feedback on deviation / investigation reports.
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Project Management
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Organize the various verification efforts, ensuring individual activities amongst the team match project priorities.
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Generate schedules to plan work and provide scenarios for various approaches or project decisions.
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Represent the instrument subsystem verification function in R&D extended team meetings.
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Work with functional management to ensure that verification projects are properly resourced.
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Organization Improvement
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Define, standardize, simplify, and streamline the instrument subsystem verification process using Design for Reliability and Manufacturing (DRM) best practices.
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Champion continuous improvement projects, such as implementing new SOPs or WIs related to instrument subsystem verification.
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Be the point of contact for any verification needs across multiple projects.
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Work with others working in verification to define consistent processes and excellence in instrument subsystem verification across the broader organization.
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Mentor other engineers in your areas of expertise.
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Regulatory Support
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Ensure the instrument subsystem verification process meets the needs of the regulatory and quality groups.
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Understand the applicable standards (IEC 60601-1, 60601-2-2, etc.) and convey verification results to the regulatory team.
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Support the development of regulatory submissions for your projects.
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Support QMS and/or DHF audits as the instrument verification SME on those projects.
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Support Risk Management activities.
Must Have: Minimum Requirements
- Bachelors degree required
- Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience
Nice to Have
· A minimum of 5 years of experience in mechanical medical device development.
· Experience applying or developing a product according to system engineering principles.
· A strong understanding of regulatory requirements for design controls and design verification.
· Ability to compile and analyze technical data using Minitab, Excel, JMP, and/or Matlab.
· Experience determining engineering specification and test requirements.
· Industry experience with statistical analysis of data.
· Experience developing mechanical systems / products, robotics, or electro-mechanical systems.
· A strong mechanical aptitude and problem-solving ability.
· Experience using electrical and mechanical test equipment.
· Strong communication and inter-personal skills.
· Successful experience working on highly complex medical device projects with multi-location teams.
Differentiating Factors
· Autonomy: Recognized expert, managing large projects or processes.
o Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager.
o Coaches, reviews, and delegates work to lower-level specialists.
· Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results.
o May manage large projects or processes that span outside of immediate job area.
· Innovation and Complexity: Problems and issues faced are difficult, moderately complex, and undefined, and require detailed information gathering, analysis and investigation.
o Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems, or products independently to enhance performance of job area.
o Implements solutions to problems.
· Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels.
o Negotiates with others to reach understanding or agreement, and influence decision-making.
· Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area.
o Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.
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. Learn more about our benefits here.
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6 here.
The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
