Sr Development Engineer I

Highridge Medical LLC; Westminster (CO); On-site; USD 83,000 - 100,000; Full time

Job summary

Highridge Medical LLC is seeking an experienced engineering professional to contribute to the design and development of innovative medical devices. Key responsibilities include managing project timelines, developing CAD models using SolidWorks, and ensuring compliance with quality assurance standards.

The ideal candidate will possess a relevant B.S. degree and 3–7 years of experience in the medical device sector, particularly in orthopaedic devices. The role offers competitive compensation and the opportunity to work in a dynamic, collaborative environment.

Qualifications

• Minimum B.S. degree in relevant engineering disciplines.
• 3–7 years of experience in the Medical device industry, especially in orthopaedic devices.
• Familiarity with design control processes and the medical device industry.

Responsibilities

• Develops project plans and manages critical project timelines.
• Contributes to the design and development of new products.
• Generates CAD models and engineering drawings primarily within SolidWorks.

Skills

CAD design

Project management

Technical communication

Quality Assurance knowledge

Problem-solving

Education

B.S. in Mechanical Engineering, Biomedical Engineering or related field

Tools

SolidWorks

Microsoft Office Suite

MS Project

Job description

Principal Duties and Responsibilities

• Contributes to the design and development of new products and improvements to existing products from conception to launch following Design Control procedures.
• Develops project plans and manages critical project timelines.
• Develops innovative solutions in a team environment to address clinical problems and translates ideas into concepts, functional prototypes and ultimately a commercialized product.
• Collects surgeon feedback and defines user needs, specifications, and performance criteria.
• Generates CAD models and engineering drawings primarily within SolidWorks.
• Authors and maintains design control documentation within a DHF.
• Supports 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.
• Participates in root cause investigations and corrective actions.
• Contributes to generation of comprehensive protocols and reports for ASTM and non-standard testing or evaluation of products.
• Contributes to invention disclosures and IP generation.

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

Expected Areas of Competence (i.e., knowledge, skills, and abilities)

• Full working knowledge of and moderate level of experience with new product development, including familiarity with design control processes.
• Demonstrated ability to methodically investigate technical issues, identify appropriate solutions, and apply current technologies to resolve problems.
• Ability to develop and maintain project schedules and track cross‑functional team progress to meet deadlines.
• Ability to identify customer complaints, process engineering change requests, address nonconforming product, and provide sound technical recommendations.
• Professional, concise, and tactful in communications with internal teams and external stakeholders, including surgeons and suppliers.
• Effectively communicates with internal personnel, external customers, and vendors to accomplish project objectives.
• Effective written and verbal communication skills, including the ability to create and deliver technical presentations.
• Working knowledge of drafting standards and geometric dimensioning and tolerancing (GD&T).
• Familiarity with and ability to support Quality Assurance and Regulatory requirements applicable to the medical device industry.
• Ability to manage multiple projects at one time throughout all stages of the development process.
• Proficient in CAD design and engineering drawings, preferably using SolidWorks.
• Proficient with Microsoft Office Suite and MS Project.

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.
• 3–7 years of experience in the Medical device industry, particularly in orthopaedic devices.

Travel Requirements: Up to 10%

Salary Range: $83,000.00 – $100,000.00

Welcome to the Highridge Medical's Career Page. Highridge Medical is committed to improving spine care by partnering with the surgeon community to drive innovation. The company has a compelling and comprehensive portfolio supported by extensive clinical evidence, including solutions for complex spine, motion preservation, minimally invasive surgery, biologics, and enabling technologies. For additional information, please visit www.highridgemedical.com.