Project Engineer – Medical Devices (Validation & Transfer)

SMC Ltd; Massachusetts; On-site; USD 84,000 - 156,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k) retirement savings

Paid holiday and PTO

Life and disability insurance

Promotional opportunities

Training and career growth programs

Employee Assistance Program

Job summary

SMC Ltd. is seeking a hands-on Project Engineer to join our global medical device team in Massachusetts.

You will participate in developing new projects from quotation support through development, validation of equipment and processes, and successful transfer to manufacturing. You will collaborate with internal and external resources to design tooling and secondary equipment, manage project deliverables, and provide technical input across manufacturing, validations, and QA areas.

Qualifications

• Research, design, and develop project elements with cross-functional teams.
• Strong interpersonal and written communication skills.
• Technical manufacturing process knowledge including workflow and equipment.
• Ability to organize, prioritize and manage multiple projects.
• Strong teamwork and problem-solving abilities.
• Experience with 3D CAD software required.

Responsibilities

• Research, design, and develop project elements, tooling, processes, automation, fixtures, and secondary equipment.
• Manage projects to meet quality and financial requirements for customers.
• Provide technical support across manufacturing, secondary operations, validations, and related areas.
• Ensure assembly testing supports robust development and manufacturing processes.
• Determine DOE objectives and resolve issues.
• Write/review validation reports and develop the Device Master Record (DMR).
• Provide post-RTM project support and problem solve.
• Maintain safe work environment per policies.
• Perform other duties as assigned.

Skills

Interpersonal communication

Written communication

Project management

Organizational skills

Team player

Problem-solving

Attention to detail

Education

Bachelor of Science in Plastics Engineering, Mechanical Engineering, or Automation Engineering

Two-year post High School diploma with 6 years related experience

Tools

3D CAD software

Job description

SMC Ltd. is seeking a hands-on Project Engineer to join our global medical device team in Massachusetts.

You will participate in developing new projects from quotation support through development, validation of equipment and processes, and successful transfer to manufacturing. You will collaborate with internal and external resources to design tooling and secondary equipment, manage project deliverables, and provide technical input across manufacturing, validations, and QA areas.