Manufacturing Engineer II (Medical Devices)

Location: Waltham, Massachusetts; onsite Monday through Friday

Salary: $90,000–$105,000 per year

Company

hirify.global develops medical and scientific instruments, consumables, and diagnostic solutions for biopharmaceutical and clinical markets.

What you will do

• Provide day-to-day engineering support for reagent, sensor, tubing, equipment, and consumable manufacturing processes.
• Investigate production issues and lead root-cause analysis, corrective actions, and effectiveness checks.
• Plan and execute engineering projects, coordinating deliverables with Manufacturing, Quality, R&D, Supply Chain, Operations, and suppliers.
• Prepare controlled documentation, engineering change orders, validation protocols, reports, SOPs, work instructions, and drawings.
• Support IQ, OQ, and PQ qualification, new-product introduction, process transfers, pilot builds, and manufacturing validation.
• Lead continuous-improvement initiatives using data analysis, Lean methods, Six Sigma tools, DOE, risk assessments, and PFMEA.

Requirements

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a related engineering discipline.
• At least 3 years of experience in manufacturing, mechanical, process, or related engineering.
• Proficiency with SolidWorks for tooling, fixture, component designs, and associated drawings.
• Experience with manufacturing investigations, process improvements, equipment changes, nonconforming product reviews, controlled documentation, change control, and validation.
• Proficiency with Microsoft Office, statistical analysis, ERP, and electronic document-control systems.
• Ability to work onsite Monday through Friday and perform the listed physical activities, including periodically lifting up to 25 pounds and wearing required PPE.

Nice to have

• Experience with Minitab, SAP, and MasterControl.
• Medical device manufacturing experience and familiarity with FDA quality-system requirements and ISO 13485.
• Six Sigma Yellow Belt certification.

Culture & Benefits

• Medical, dental, and vision coverage.
• Competitive 401(k) company match and bonus program.
• Generous paid time off, paid holidays, and tuition reimbursement.
• Professional development opportunities, engagement activities, and company events.
• Workplace food and cafeteria benefits at selected Massachusetts and Maine offices.