Senior Consultant - R&D

Novozen Healthcare LLC; Indiana; In loco; USD 90.000 - 96.000; Tempo pieno

Vantaggi offerti da questo lavoro

Benefits package

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

15+ years exp

Design controls

DHF

Change control

QMS

Lean Six Sigma

AI automation

Leadership

Stakeholder management

Regulatory knowledge

Formazione

Bachelor's degree

Strumenti

AI/Automation workflows

Descrizione del lavoro

Job Title: Senior Consultant – Product Delivery Excellence & R&D Process Simplification

Duration: 12 Months

Employment Type: W2

Position Summary

Seeking an experienced consultant to simplify R&D and product development processes, improve efficiency, align workflows with QMS requirements, and implement AI and automation solutions in a regulated medical device environment.

Key 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 appropriate governance.
• Lead process improvement initiatives and track measurable results.
• Collaborate with R&D, Quality, and Regulatory teams to maintain compliance.

Requirements:

• Bachelor’s degree in a relevant field.
• Typically 15+ years of relevant experience, including medical products industry experience.
• Strong knowledge of design controls, DHF, change control, and QMS.
• Experience with Lean, Six Sigma, and process improvement.
• Practical experience with AI or automation workflows.
• Knowledge of FDA Quality System requirements and ISO 13485.
• Strong leadership, communication, and stakeholder-management skills.

Salary: The hourly rate for this position is 65-70 per hour. (Depends on experience)

Benefits: Eligible employees may enroll in and receive benefits offered by NovoZen Healthcare LLC, subject to applicable plan terms, eligibility criteria, and contribution requirements.

Equal Employment Opportunity: NovoZen Healthcare LLC is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

Background Check: Background checks may be conducted in accordance with applicable law.

Work Authorization: Applicants must be authorized to work in the United States