Dev Sr Engineer II

HighRidge Medical LLC•Westminster, CO

About The Position

Highridge Medical creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation to MIS to Bone Healing to Core Spine. Working at Highridge Medical is not just work. Life at Highridge Medical is purpose driven. Every day, you have the privilege of using your talents to demonstrate Confidence in your work and restore Confidence for our patients. Confidence that moves. We are seeking a Senior Development Engineer II 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.

Requirements

Full working knowledge of and 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
Expertise in CAD design and engineering drawings, 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
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.
5-7 years of experience in the Medical device industry, particularly in Orthopaedic devices

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 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 larger projects while also managing multiple smaller projects throughout all states of the development process.
Leads and/or participate 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.