Manufacturing Engineer

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

Manufacturing Engineer – Medical Devices

Boston, Massachusetts | Remote | Freelance Contract | Part-Time Initially (20 Hours per Week)

The Opportunity

A growing medical-device business is looking to engage an experienced Manufacturing Engineer on a freelance basis to support its manufacturing operations, process development and ongoing engineering activities.

This is an excellent opportunity to join a developing medical-device organisation where you will play an important role in improving manufacturing processes, supporting product industrialisation and ensuring products can be manufactured consistently, efficiently and in line with the relevant quality and regulatory requirements.

The engagement will initially be approximately 20 hours per week, with the flexibility to work fully remotely. As the business and workload develop, the requirement is expected to increase progressively towards full-time hours.

We are looking for someone with a strong engineering background and practical experience within the medical-device sector, ideally someone comfortable working autonomously and providing hands‑on technical support within a growing business.

Key Responsibilities

Manufacturing Engineering & Process Development

• Support the development, implementation and optimisation of manufacturing processes for medical-device products.
• Review existing manufacturing methods and identify opportunities to improve efficiency, consistency, productivity and product quality.
• Develop and improve manufacturing procedures, work instructions, process documentation and standard operating procedures.
• Provide engineering input into new product introduction (NPI), product industrialisation and manufacturing readiness.
• Support the transition of products from design and development into repeatable manufacturing processes.
• Identify potential manufacturing risks and recommend practical engineering solutions.

Process Validation & Quality

• Support the development and execution of process validation activities, including IQ, OQ and PQ where applicable.
• Ensure manufacturing processes are developed and maintained in accordance with relevant medical-device quality standards and regulatory requirements.
• Work closely with Quality and Regulatory teams to support compliance with FDA requirements and ISO 13485.
• Assist with investigations into manufacturing issues, non-conformances and process deviations.
• Support root cause analysis and the implementation of corrective and preventive actions (CAPA).
• Contribute to process risk assessments, FMEAs and continuous improvement activities.

Product & Design Support

• Work alongside R&D, Product Development and Quality teams to ensure products are designed with manufacturability in mind.
• Provide Design for Manufacturability (DFM) input and identify opportunities to simplify or improve product design.
• Support engineering changes, design transfers and manufacturing documentation updates.
• Help resolve technical issues relating to product performance, materials, components and manufacturing methods.
• Assist with supplier and component-related engineering issues where required.
• Identify opportunities to reduce manufacturing costs, waste and process variation.
• Apply structured problem-solving and continuous improvement methodologies.
• Review manufacturing data and performance metrics to identify trends and areas for improvement.
• Recommend practical solutions to improve process reliability, repeatability and scalability.

Experience & Background

We are looking for someone with:

• Proven experience as a Manufacturing Engineer, Process Engineer or similar engineering role within the medical-device industry.
• A strong understanding of medical-device manufacturing processes and engineering principles.
• Experience supporting manufacturing process development, optimisation and troubleshooting.
• Knowledge of FDA medical-device requirements and ISO 13485 quality management systems.
• Experience with process validation, manufacturing documentation and engineering change control.
• Understanding of risk management, process FMEA and root cause analysis.
• Experience working cross-functionally with Quality, Regulatory, R&D and Product Development teams.
• The ability to work independently, manage priorities and provide practical engineering support within a growing organisation.
• Working arrangement: 100% remote
• Contract: Freelance / independent contractor
• Initial commitment: Approximately 20 hours per week
• Future requirement: Expected to ramp up towards full-time hours as the business develops

The Ideal Person

This role would suit a hands‑on Manufacturing Engineer who understands the specific demands of developing and manufacturing regulated medical devices. You will be comfortable working independently, taking ownership of engineering activities and helping a growing business strengthen and scale its manufacturing capabilities.

If you have relevant medical-device manufacturing experience and are interested in an initial part‑time freelance engagement with the potential to develop into a full‑time commitment, we would be keen to hear from you.