Principal Product Engineer- Machine Design

Medtronic • Lafayette, CO

5d • Hybrid

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. Responsibilities may include the following and other duties may be assigned.

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.

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.

Benefits

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Principal