Senior Manufacturing Engineer (MedTech)

TL;DR

Senior Manufacturing Engineer (MedTech): Leading the development, validation, and continuous improvement of manufacturing processes for medical devices with an accent on FDA and ISO 13485 compliance. Focus on executing complex process validations (IQ/OQ/PQ), applying statistical methods for quality control, and driving Design for Manufacturability (DFM) initiatives.

Location: Must be based in Westminster, CO

Salary: $115,000–$125,000

Company

hirify.global is a staffing and recruitment firm specializing in technical and scientific placements.

What you will do

• Lead cross-functional projects from concept through commercialization and design transfer.
• Develop and execute process validation protocols (IQ/OQ/PQ) and maintain validation master plans.
• Apply statistical methods like DOE, SPC, and MSA to characterize and control manufacturing processes.
• Drive risk management activities, including PFMEA authorship and review.
• Implement Lean manufacturing principles to optimize production workflows and equipment utilization.
• Manage investigations of nonconformances and support CAPA activities.

Requirements

• Minimum 10 years of experience in a medical device manufacturing environment.
• Proven experience with FDA regulated work and ISO 13485 standards.
• Demonstrated expertise in leading process validations (IQ/OQ/PQ).
• BS in Mechanical or Biomedical Engineering or a related scientific discipline.
• Strong proficiency in statistical methods (DOE, SPC, MSA).
• Ability to read, write, and understand English.

Culture & Benefits

• Major medical, dental, and vision insurance coverage.
• 401k retirement plan participation.
• Statutory sick pay where required.
• Commitment to providing reasonable accommodations for individuals with disabilities.
• Inclusive hiring practices considering qualified applicants with diverse backgrounds.