Project Engineer II — Medical Device Molds & Validation

Socket.dev; Harvard (MA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k) retirement savings

Paid holiday and PTO

Tuition reimbursement

Life and disability insurance

Training and career growth programs

Employee Assistance Program

Job summary

SMC Ltd. is a global supplier to the medical market seeking a Project Engineer to drive mold design, tooling, and manufacturing process development from quotation through transfer to production.

You will coordinate with internal/external teams, manage timelines, ensure quality and cost targets, and provide technical guidance across product design, material selection, and validation activities.

Qualifications

• Bachelor of Science degree in Plastics Engineering, Mechanical Engineering, or Automation Engineering, and 2 years related experience OR a two-year post High School diploma and 6 years related experience.
• Demonstrated effective interpersonal and communication skills, including written communication.
• Experience implementing decoupled molding processes and scientific molding techniques.
• Technical skills in manufacturing processes and methods including workflow, layout, assembly and production equipment.
• Ability to organize, prioritize and manage multiple projects.
• Demonstrated team player
• Excellent problem-solving skills with attention to detail.
• Working knowledge of 3D CAD software.

Responsibilities

• Work with internal / external resources to research, design, and develop the necessary elements of project molds, tooling, processes, automation, fixtures, EOAT, and secondary equipment.
• Develop project timelines that support our quoted lead-times, and incorporate the customer requirements for validation, pilot builds, and approval.
• Manage projects to ensure customer deliverables to meet quality and financial requirements.
• Deploy good project management techniques with internal and external teams Act as a technical resource to the customer.
• Review product design for compliance with engineering principles/ standards and ensure adherence to customer requirements /specifications.
• Provide technical support and input in the areas of product design, material selection, mold design, manufacturing, secondary operations, validations and other areas related to our industry.
• Ensure mold, process, or assembly testing is performed in an appropriate to provide a thorough development, and a robust manufacturing process.
• Determine testing and Design of Experiments (DOE) objectives and resolve any issues found.
• Write /review validation reports and summaries related to the project. Develop the Device Master Record (DMR), and ensure internal documentation and systems are current at the time of the Release to Manufacturing (RTM).
• Provide internal support for the project after RTM, and problem solve as needed.
• Ensure a safe work environment by following all company safety policies and procedures.
• Perform all other duties assigned.

Skills

Interpersonal communication

Written communication

Problem-solving

Team player

Organization

Education

BS in Plastics/Mechanical/Automation Engineering

2+ years related experience OR 6 years post-HS with experience

Tools

3D CAD software

SolidWorks

Job description

SMC Ltd. is a global supplier to the medical market seeking a Project Engineer to drive mold design, tooling, and manufacturing process development from quotation through transfer to production.

You will coordinate with internal/external teams, manage timelines, ensure quality and cost targets, and provide technical guidance across product design, material selection, and validation activities.