R&D Test Engineer (Denver, CO)
Who We Are
Stryker’s Sports Medicine?business delivers a wide range of innovative sports medicine solutions – from implants and biologic products for soft tissue repair and healing, to pre-operative surgical planning software and surgical tools for accurate soft tissue and boney resection. Our focus is on minimally invasive and open approaches to the shoulder, knee, hip, and small joints. Our goal is to restore someone’s normal lifestyle after an injury, explained in our motto of “motion regained, life renewed”. As one of the fastest growing businesses at Stryker, this is an exciting and impactful time to join our team!?
Position Summary
As an R&D Test Engineer, you will be an integral part of both the new product development and product sustainment teams. Within the new product development process, this role will drive the functional evaluation of our products in the pre-market lifecycle, ultimately being responsible for the verification of design specifications on our mechanical surgical instruments. Within the product engineering sustainment process, this role will drive design changes on commercial products to improve upon performance, safety, compliance, or cost. These changes include material changes, compliance to new testing standards, improvements to the product to address issues, implementing new test methods, supporting process improvement efforts, managing product line extensions or manufacturing transfers of critical components for the Sports Medicine business. To know more about the products Click here
Who We Want
Achievers: Goal oriented engineers who are committed to the project objectives and are driven to launch new, winning technologies to the market that help change patients’ lives.
Influencers: People who constantly challenge themselves and each other to achieve more and win the right way.
Teammates: Partners who listen to ideas, share thoughts, and work together to improve their team.
Creative problem solvers: People who go beyond just fixing to identify root causes, evaluate optimal solutions, and implement hard to find solutions to improve outcomes for patients.
What You Will Do:
Technical Responsibilities
Understand the intended use and functional specifications of a device
Lead testing activities for design changes. Accountable for test strategy and execution and testing on a product from experimentation to design verification.
Improve and/or develop new test methods using latest technology that are accurate, time-efficient, and cost effective.
Design tests to fully measure requirements listed in the functional specifications, including automated test fixtures to execute tests
Verify fixtures and qualify test methods used for verification and validation
Generate documentation for supporting verification and validation activities including test methods, test protocols, and test reports. Draw conclusions from test data.
Business Responsibilities:
Coordinate cross-functionally with Design, Regulatory, Quality Assurance, Production, Manufacturing, and Supply Chain to implement design changes.
Supports Regulatory filing by providing technical input and responding to questions from Regulatory agencies.
Apply understanding of clinical procedures to enhance product and patient outcomes.
Demonstrate developing financial acumen.
Communicate plans and technical information to team members, leaders, and project managers.
Med Device Compliance
Understand fundamental industry standards, design requirements and test strategies which align with regulatory requirements.
Learn R&D procedures like design controls and risk management, per the Quality Management System.
General Responsibilities
Work cooperatively with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success and contribute to the project as a team member.
Learn procedures, policies, processes, systems, and technology required.
What You Will Need
Must Haves
Bachelor’s degree (B.S.) in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or related curriculum
Must be able to read, write, and speak fluently in English about technical subject matter
Preferred/Nice to haves
Technical Skills
Experience working in a regulated environment; knowledge of medical device quality systems, manufacturing, and design controls
Knowledge of analysis tools and statistical methods
Ability to analyze and correct complex designs
Excellent analytical and problem-solving skills
Strong technical writing skills for reports, protocols, procedures, and correspondence
Physical Requirements
Ability to operate small hand tools (e.g. pliers, screwdrivers, hammer, wrenches, etc.), power tools and test/inspection equipment
Exerting up to 30 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, etc.
Must have the ability to work with and assemble small objects and component parts
Must have good visual acuity and demonstrate fine motor skills
Must be able to observe and correct minute inconsistencies (e.g. in the printed word, product appearance, etc.)
