Principal Product Engineer- Machine Design

Medtronic•Lafayette, CO

6d•$124,000 - $186,000•Onsite

About The Position

We are seeking a Principal Engineer, Machine Design, to lead the design, development, and implementation of manufacturing equipment, fixtures, tooling, and automation systems used in a regulated medical device environment. This role requires deep expertise in mechanical design, advanced SolidWorks capability, engineering documentation, and strong cross-functional leadership. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working onsite 4 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Requirements

Requires a Baccalaureate degree and minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience.
Significant experience in machine design, automation, manufacturing equipment, or capital equipment development.
Advanced SolidWorks proficiency, including complex assemblies, detailed mechanical drawings, and formal design documentation.
Strong experience developing accurate, detailed, and controlled engineering documentation in regulated or highly quality-focused environments.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

Bachelor’s degree in Mechanical Engineering or related engineering discipline.
Master’s degree in Mechanical Engineering or related field.
Strong knowledge of mechanical design principles, GD&T, tolerance analysis, material selection, and manufacturing processes.
Experience with automation systems, robotics, motion control, pneumatics, vision systems, or mechatronics.
Working knowledge of PDM/PLM systems, FEA, and structured engineering change processes.
Direct experience in medical device manufacturing equipment design and validation.
Experience with equipment qualification documentation, including IQ/OQ/PQ protocols, test methods, and validation summary support.
Experience working in cross-functional teams with Quality, Validation, Manufacturing, Controls, and Operations.
Strong working knowledge of document control, change control, and traceability expectations in regulated development or manufacturing environments.
Proven ability to lead technical projects and manage timelines, risks, and deliverables.
Strong written and verbal communication skills with exceptional attention to detail.

Responsibilities

Lead the mechanical design and development of custom machines, automation systems, tooling, fixtures, and manufacturing equipment for medical device development and production environments.
Create and maintain detailed 3D CAD models, assemblies, drawings, and bills of materials in SolidWorks with a high level of accuracy, completeness, and revision discipline.
Support equipment qualification and validation activities, including development and execution support for IQ, OQ, and PQ documentation as applicable.
Contribute to user requirements, functional specifications, design specifications, risk assessments, and test plans.
Collaborate across mechanical, electrical, software, controls, manufacturing, quality, and operations teams to develop integrated systems that meet performance, reliability, safety, and compliance requirements.
Participate in and lead design reviews with a focus on design robustness, manufacturability, maintainability, risk mitigation, validation support, and readiness for release.
Support equipment FAT, SAT, commissioning, troubleshooting, and post-installation performance investigations.
Perform engineering analyses such as tolerance stack-ups, failure analysis, root cause investigations, and design for manufacturability/assembly assessments.
Manage project scope, schedules, technical deliverables, risks, and stakeholder communication for machine design projects from concept through release.
Mentor engineers and promote best practices in design controls, documentation discipline, validation support, and cross-functional execution.