R&D Process Excellence Consultant — Medical Devices & AI

Novozen Healthcare LLC; Indiana; On-site; USD 90,000 - 96,000; Full time

Benefits offered by this job

Benefits package

Job summary

NovoZen Healthcare LLC seeks a Senior Consultant to streamline R&D and product development processes, reducing cycle times and rework while aligning with QMS. You will guide governance for AI and automation solutions and drive cross-functional improvements across R&D, Quality, and Regulatory teams.

The role requires extensive experience with design controls, DHF, and change control, plus strong leadership and stakeholder-management skills in a regulated medical device environment.

Qualifications

• Bachelor’s degree required.
• 15+ years of relevant experience in medical products or similar industry.
• Strong knowledge of design controls, DHF, change control, and QMS.

Responsibilities

• Assess and simplify R&D and QMS processes to reduce cycle time and rework.
• Improve workflows, design controls, documentation, and cross-functional handoffs.
• Implement AI and automation solutions with governance.
• Lead process improvement initiatives and track measurable results.
• Collaborate with R&D, Quality, and Regulatory teams to maintain compliance.

Skills

15+ years exp

Design controls

DHF

Change control

QMS

Lean Six Sigma

AI automation

Leadership

Stakeholder management

Regulatory knowledge

Education

Bachelor's degree

Tools

AI/Automation workflows

Job description

NovoZen Healthcare LLC seeks a Senior Consultant to streamline R&D and product development processes, reducing cycle times and rework while aligning with QMS. You will guide governance for AI and automation solutions and drive cross-functional improvements across R&D, Quality, and Regulatory teams.

The role requires extensive experience with design controls, DHF, and change control, plus strong leadership and stakeholder-management skills in a regulated medical device environment.