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Role Description

We are seeking a Development Principal Engineer responsible for the design and development of spinal implants and instruments. This individual will lead large-scope, cross-functional projects with minimal guidance and support both new product development and sustaining engineering. The engineer is expected to interact directly with surgeons and cross-functional stakeholders such as Marketing, Regulatory, Quality, Testing, and Sales. In the role they should also demonstrate initiative, strong technical leadership, and the ability to make high-level design decisions that impact implant and instrument systems across spinal procedures. Occasional travel and mentoring of junior engineers is expected.

Principal Duties and Responsibilities

• Leads the design and development of new products and improvements to existing products from conception to launch following Design Control procedures.
• Leads the creation of project plans and manages critical project timelines.
• Leads the development of innovative, clinically driven solutions by anticipating surgical needs and identifying unmet opportunities, transforming concepts into commercialized implant and instrument systems.
• Collects customer (surgeon) feedback and defines user needs, specifications, and performance criteria.
• Generates CAD models and engineering drawings primarily within Solidworks.
• Designs complex mechanisms/instrumentation and implements advanced design principles.
• Authors and maintains design control documentation within a DHF.
• Leads test strategy development and contributes to test protocol/report creation.
• Defines and executes verification and validation activities with support from testing and quality teams.
• Designs components for manufacturability, inspectability, and cost-effectiveness.
• Ability to lead large scale projects while also managing multiple smaller projects throughout all states of the development process.
• Leads and/or participates in root cause investigations and corrective actions.
• Creates comprehensive protocols and reports for ASTM testing or evaluation of products.
• Creates invention disclosures and IP generation.

Expected Areas of Competence

• Full working knowledge (advanced level of experience) with new product development, including design control, regulatory compliance, and cross-functional execution.
• Demonstrated ability to independently investigate complex problems, develop robust solutions, and lead their implementation across functional teams.
• Ability to create and manage project schedules, proactively drive cross-functional progress, and adjust plans to meet strategic objectives.
• Ability to lead resolution of customer complaints, drive engineering change requests, manage nonconforming product, and make recommendations based upon business principles.
• Professional, concise, tactful, and effective in communications. Influences and aligns internal teams and external stakeholders including surgeons and vendors.
• Strong written and verbal communication skills, including preparation and delivery of presentations tailored to technical and executive audiences.
• Advanced working knowledge of drafting standards and geometric dimensioning and tolerancing (GD&T).
• Demonstrated ability to ensure product and process compliance with applicable Quality Assurance and Regulatory requirements in the medical device industry.
• Ability to manage and set priorities for multiple complex projects and deliverables concurrently.
• Proficient in CAD design, engineering drawing creation, and DFM, preferably using SolidWorks, with an emphasis on design for manufacturability and system integration.
• Proficient with Microsoft Office Suite and MS Project, with experience in reporting and tracking project metrics.

Education/Experience Requirements

• Minimum B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering.
• 7+ years of experience in the Medical device industry, particularly in Orthopedic device.

Travel Requirements

• Up to 10%.
• Willing to consider remote position for candidates for exceptional experience and qualifications.