Principal Mechanical Engineer - Advanced Surgical

About the role

This position is for a critical member of our Advanced Surgical division's R&D team, based in Denver, CO.

Responsibilities

• Own the design and development of high-quality and reliable disposable and/or capital medical products for surgical procedures, ensuring exceptional performance and adherence to industry standards while maintaining consistent product continuity for our customers.
• Create designs that balance performance, cost, manufacturability, and reliability while minimizing unnecessary complexity.
• Serve as a technical authority across all phases of design and development, applying sound engineering principles, data-driven decision-making, and disciplined processes to manage risk and ensure patient safety.
• Execute design, prototyping, verification, validation, and manufacturing activities with appropriate documentation and rigor.
• Develop test protocols, analyze results, and document findings with clarity and precision.
• Teach and mentor others to do the same.
• Maintain accurate and complete technical documentation, including requirements, specifications, and design outputs.
• Collaborate with cross-functional partners to plan work, manage timelines, and deliver project milestones.
• Own technical direction and key design decisions across the product lifecycle, ensuring alignment with system-level requirements, risk, and business objectives.
• Assume full responsibility for all phases of design, development, component procurement, assembly, verification, validation, and manufacturing, ensuring compliance with medical device standards and regulations.
• Lead structured root-cause investigations using data and systematic problem-solving methods. Implement robust corrective and preventive actions.
• Oversee conceptual designs, detailed designs, CAD modeling, prototyping, and troubleshooting, working independently across all aspects of the product development cycle.
• Plan and execute verification and validation activities guided by risk, data, and intended use – not just compliance – ensuring designs are robust, safe, and clinically meaningful.
• Lead and influence cross-functional teams and stakeholders, aligning technical decisions with broader program, clinical, and business objectives.
• Engage with surgeons, clinicians, and internal stakeholders to deeply understand unmet needs, problem context, and constraints before defining requirements and pursuing solutions.
• Define and frame complex or ambiguous engineering problems, guiding teams toward effective solutions based on structured analysis.
• Take ownership of design quality and project deliverables, ensuring compliance while proactively identifying risks and driving timely resolution.
• Guarantee that all designs comply with relevant industry standards, safety regulations, and quality control procedures.
• Communicate risks, tradeoffs, and technical decisions clearly and early to stakeholders, enabling timely decisions and shared ownership of outcomes.
• Take ownership of technical outcomes throughout the product lifecycle, proactively surfacing risks, driving corrective actions, and following through closure.
• Aid in building team capability by mentoring engineers, strengthening engineering standards, and scaling best practices across programs.
• Frame engineering problems clearly, explore alternatives thoughtfully, and select solutions based on structured analysis rather than assumption or urgency.
• Make and guide high-impact technical decisions, balancing risk, speed, complexity, and performance.

  Qualifications

  • 10+ years engineering work experience required (8+ years with related Master’s degree or 5+ with a PhD).
  • B.S. in Mechanical Engineering (or highly related field) required.
  • Mastery of 3-D CAD software such as SolidWorks or equivalent.
  • Proficiency using GD&T and creating engineering drawings.
  • Expertise in mechanical design principles, including stress analysis and materials selection.
  • Demonstrated ability to simplify designs and trade complexity for reliability, manufacturability, and serviceability.
  • Demonstrated knowledge of design for manufacturing, such as machining, injection molding, and assembly.
  • General understanding of relevant technologies, including hardware design and mechanics.
  • Ability to collaborate effectively across functions and contribute to team alignment and execution.
  • Demonstrated analytical, problem-solving, and technical communication skills.
  • Experience applying structured problem-solving methods (e.g., root cause analysis, DOE, FMEA).
  • Strong judgment in technical prioritization, trade-off decisions, and execution in a regulated R&D environment.

  Preferred Qualifications

  • Experience working in a regulated environment, such as FDA 21 CFR 820 or similar.
  • Strong knowledge of FEA / CFD tools.
  • Strong understanding of medical device regulations.
  • Knowledge in root cause investigations and problem solving.
  • Mastery of project management principles and budgeting.
  • Experience developing new products.
  • Experience in the design of electro-mechanical devices.

  Pay

  The annual salary range for this position is $118,000 - $190,000. The actual compensation may vary based on geographic location, work experience, education and skill level.

  Schedule

  Full-time, Monday through Friday.