Clinical Process Improvement Engineer I

What You Can Expect

Paragon 28 (Zimmer Biomet) is hiring a Clinical Process Improvement Engineer I

The Clinical Process Improvement Engineer I is responsible for improving, standardizing, validating, and sustaining clinical engineering processes that support the design and development of patient-matched devices, including Patient Specific Instrumentation and Implants. This role focuses on strengthening design input and design output practices, verification and validation readiness, structural integrity evaluation, and the creation and validation of templates and automation tools that improve quality, consistency, and efficiency across the patient-matched design and development process.

This position requires onsite presence at our Englewood Colorado location.

How You'll Create Impact

· Lead clinical process improvement initiatives for patient-matched device design and development workflows, with emphasis on safety, quality, efficiency, and consistency.

· Partner with Clinical Engineering, R&D, Quality, Regulatory, Manufacturing, and Commercial teams to translate patient anatomy, surgeon requirements, and clinical use cases into clear design inputs and acceptance criteria.

· Develop, refine, and maintain design input, design output, design review, risk, traceability, and change-control templates for patient-matched instrumentation and implant development.

· Support verification and validation planning for patient-matched devices based on Clinical and Biomedical expertise, including protocol development, test method definition, sample rationale, acceptance criteria, data review, and report approval.

· Perform and/or coordinate structural integrity evaluations for patient-matched designs, including design rationale, mechanical risk assessment, dimensional review, simulation or analytical assessment, and escalation of design concerns.

· Evaluate design outputs, including drawings, models, specifications, surgical plans, manufacturing instructions, inspection criteria, and engineering reports, to confirm alignment with approved design inputs.

· Create, standardize, and improve automation tools, templates, checklists, and workflow aids used in clinical engineering and patient-matched design processes.

· Define validation strategies and execute validation activities for engineering templates and automation tools, including requirements, intended use, test scripts, traceability, release criteria, and change controls.

· Establish and monitor KPIs for clinical engineering process performance, design review quality, first-pass yield, turnaround time, V&V readiness, documentation completeness, and recurring defect trends.

· Lead root-cause investigations and corrective/preventive actions related to patient-matched design nonconformances, documentation gaps, workflow defects, and design transfer issues based on clinical feedback received

· Support design transfer and sustaining engineering activities by ensuring clinical engineering outputs are manufacturable, inspectable, traceable, and compliant with applicable procedures.

· Ensure collaboration between Clinical Engineering and Manufacturing group by bridging the skillset gaps and providing knowledge in both areas

· Prepare and present technical reports, process maps, validation packages, training materials, and management updates to support decision-making and implementation of improvements.

· Train and mentor engineers and designers and cross-functional users on standardized templates, automation tools, design control expectations, V&V documentation, and patient-matched design best practices.

· Ensure compliance with company procedures, design control requirements, FDA Quality System Regulation, ISO 13485, GMP expectations, and applicable regulatory standards.

Your Background

· Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Clinical Engineering, or a related engineering discipline; advanced degree preferred.

· Minimum of 3-5 years of experience in the medical device industry, preferably supporting patient-specific, patient-matched, custom, orthopedic, or implantable device programs.

· Strong Clinical Engineering background with demonstrated ability to translate clinical needs, patient anatomy, surgeon feedback, and procedural requirements into engineering requirements.

· Demonstrated ability to conduct effective and direct communications with surgeons and end-user customers to identify and implement design and clinical process improvement opportunities

· In-depth understanding of design controls, including design inputs, design outputs, design reviews, traceability, risk management, verification, validation, and design transfer.

· Hands-on experience developing and reviewing V&V protocols, reports, test methods, acceptance criteria, and objective evidence for medical device design and development activities.

· Experience with structural integrity evaluation, mechanical design assessment, finite element analysis review, dimensional tolerance evaluation, or related engineering justification for patient-matched devices.

· Demonstrated ability to create, standardize, and maintain templates, checklists, work instructions, process maps, and automation tools used in engineering or design workflows.

· Experience validating engineering tools, templates, spreadsheets, scripts, or workflow automation in accordance with intended use, requirements, test evidence, and change-control expectations.

· Ability to review, interpret, and approve technical documentation, including CAD models, engineering drawings, specifications, surgical plans, protocols, test reports, risk documents, and DHF records.

· Working knowledge of FDA regulations, ISO 13485, GMP, risk management principles, and medical device quality system requirements.

· Strong analytical, problem-solving, and process-mapping skills with the ability to convert recurring issues into scalable process improvements.

· Proficiency in Microsoft Office Suite and experience with engineering documentation systems, PLM/QMS tools, CAD viewers, statistical tools, or workflow automation platforms.

· Excellent written and verbal communication skills with the ability to influence cross-functional stakeholders, facilitate technical reviews, and train engineering teams.

· Demonstrated project management skills with the ability to manage multiple priorities, meet deadlines, and drive implementation in a regulated environment.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones and copy machines. Occasional use of the development lab may be necessary, adhering to all lab safety requirements. The role may involve collaboration with clinical engineering, design, testing, quality, regulatory, and manufacturing teams.

Physical Demands

The role requires regular communication with internal and external stakeholders, frequent movement within the facility, and close visual acuity for reviewing models, drawings, documentation, and small parts. The employee may be required to lift up to 35 lbs. independently.

Position Type/Expected Hours of Work

This is a full-time position with typical business hours. It may reasonably require additional hours during the week and weekend; specific requirements will be determined with Manager. Occasional remote work may be allowed.

Travel Expectations

Up to 15% of overnight travel.

Compensation Data

Salary Range:  $80,000 - $90,000 USD annually