Process Development Engineer II - Medical Devices

Cirtec Medical; Lowell (MA); On-site; USD 80,000 - 90,000; Full time

Benefits offered by this job

Training and career development

Health care & wellness programs

Paid Time Off and 401(k)

Job summary

Cirtec Medical Corp. in Lowell, MA seeks an Engineer II – Process Development to design, develop, and qualify manufacturing processes for medical devices.

You will support product development, prototyping, process validation, and manufacturing transfer, working cross-functionally with engineering, quality, and operations. The role focuses on creating process specifications, PFMEA, risk controls, and documentation to meet regulatory standards.

Qualifications

• Bachelor’s degree in a STEM field.
• Minimum 2 years engineering experience.
• Experience with mechanical, tool design and manufacturing processes.
• Fluent English, able to read/write.
• Willingness to travel.
• Experience with Minitab and statistics.
• Ability to read technical drawings.
• Knowledge of documented change control processes.

Responsibilities

• Design, develop, and qualify manufacturing processes for medical-device products.
• Support product development activities including prototyping and process transfer.
• Serve as primary customer contact for low- to moderate-complexity programs.
• Coordinate meetings to review development activities and milestones.
• Develop work instructions, process specifications, and documentation.
• Perform PFMEA and implement risk controls.
• Provide technical training to production operators.
• Ensure compliance with quality systems and regulatory requirements.

Skills

B.S. in STEM

2+ years exp

Minitab stats

Technical drawings

English fluent

Process development

Education

Bachelor’s degree in STEM

Tools

PFMEA

Job description

Cirtec Medical Corp. in Lowell, MA seeks an Engineer II – Process Development to design, develop, and qualify manufacturing processes for medical devices.

You will support product development, prototyping, process validation, and manufacturing transfer, working cross-functionally with engineering, quality, and operations. The role focuses on creating process specifications, PFMEA, risk controls, and documentation to meet regulatory standards.