Remote Freelance Manufacturing Engineer – Med Devices

Maclivaro Limited; Boston (MA); Remote; USD 76,000 - 124,000; Part time

Benefits offered by this job

Remote work

Freelance/independent contractor

Part-time (20 hours/week)

Job summary

Maclivaro Limited is seeking an experienced Manufacturing Engineer for a freelance, part-time role (about 20 hours per week) in the Boston area with remote work options. The position supports development and optimization of manufacturing processes for medical-device products and requires knowledge of FDA and ISO 13485 standards.

You will collaborate with R&D, Quality and Regulatory teams to enable manufacturability, process validation and CAPA, and to transition products from design to

Qualifications

• Experience in medical-device manufacturing and process development.
• Knowledge of FDA medical-device requirements and ISO 13485.
• Experience with process validation, IQ/OQ/PQ and CAPA.
• Ability to work remotely on a freelance basis.

Responsibilities

• Develop and optimize manufacturing processes for medical devices.
• Support NPI, product industrialisation and manufacturing readiness.
• Assist with design for manufacturability (DFM) inputs and manufacturing documentation.
• Identify opportunities to reduce costs, waste and process variation.
• Collaborate with Quality and Regulatory teams to ensure compliance.

Skills

Manufacturing engineering

Process development

Regulatory awareness

Problem solving

Independent worker

Cross-functional collaboration

Job description

Maclivaro Limited is seeking an experienced Manufacturing Engineer for a freelance, part-time role (about 20 hours per week) in the Boston area with remote work options. The position supports development and optimization of manufacturing processes for medical-device products and requires knowledge of FDA and ISO 13485 standards.

You will collaborate with R&D, Quality and Regulatory teams to enable manufacturability, process validation and CAPA, and to transition products from design to