Manufacturing Engineer

Planet Pharma; Woburn (MA); On-site; USD 70,000 - 100,000; Full time

Job summary

Planet Pharma in Woburn, MA is seeking a Manufacturing Engineer to own engineering support for manufacturing operations, taking processes from specification and validation through scale-up and continuous improvement while staying compliant with FDA QMSR and ISO 13485.

You will set up new processes, lead scale-up to hit targets for yield, capacity, and productivity; design lean production lines; coordinate with R&D, Quality and Operations to move products from development to production.

Qualifications

• Bachelor’s degree in engineering or equivalent.
• 1+ years in a manufacturing or process engineering role, preferably in medical devices.
• Hands-on experience with process validation (IQ/OQ/PQ) and equipment qualification.
• Strong technical writing, with ability to produce protocols and reports.
• Able to move between hands-on work and guiding technicians and cross-functional partners.

Responsibilities

• Set up new manufacturing processes and improve existing ones.
• Lead scale-up and commercialization to hit targets for yield and throughput.
• Design lean production lines focusing on flow and layout.
• Provide daily engineering support to Production and ensure regulatory compliance.
• Train product builders and transfer knowledge for new processes.

Skills

Manufacturing experience

Process engineering

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in engineering

Tools

IQ/OQ/PQ protocols

Factory Acceptance Tests (FATs)

pFMEA

Job description

Job description

The Manufacturing Engineer owns engineering support for our manufacturing operations. The role takes processes and equipment from specification and validation through scale-up, and then keeps improving them in day‑to‑day production, while staying compliant with FDA QMSR (21 CFR 820) and ISO 13485.

Primary Responsibilities

Process development and scale-up

• Set up new manufacturing processes and improve existing ones.

• Lead scale-up and commercialization of new processes so they hit targets for yield, capacity, throughput time and productivity.

• Help design and build lean production lines, with attention to flow, throughput time, material movement, layout and space.

• Work with R&D, Quality and Operations so products move from development through approval and into production smoothly, on time and cost‑effectively.

Equipment and validation

• Own the equipment lifecycle: specification, procurement, installation and validation.

• Write and run Factory Acceptance Tests (FATs), both on‑site and at vendors, for equipment used in processes where we own the product or process design.

• Write and execute IQ/OQ/PQ protocols and reports for equipment, process and product validations, in line with regulatory requirements.

• Set up preventive maintenance and calibration programs.

Documentation and materials

• Create and maintain manufacturing documentation: equipment files, pFMEAs, TMVs, bills of materials, part numbers, product routings, manufacturing procedures and logs.

• Specify and order the components, consumables and materials needed for validation and production.

Production support and training

• Provide daily engineering support to Production, and keep driving better operating performance without compromising regulatory compliance.

• Lead knowledge transfer for new processes and train product builders and technicians.

Qualifications

• Bachelor’s degree in engineering (mechanical, biomedical, chemical or manufacturing preferred) or equivalent.

• 1+ years in a manufacturing or process engineering role. Medical device or other regulated‑industry experience strongly preferred.

• Hands‑on experience with process validation (IQ/OQ/PQ), equipment qualification and pFMEA.

• Strong technical writing skills, with a record of producing protocols, reports and procedures.

• Execution‑focused: comfortable moving between hands‑on work and guiding technicians and cross‑functional partners.