Sustaining Manufacturing Engineer II - Medical Devices

Instylla; Bedford (MA); On-site; USD 85,000 - 120,000; Full time

Job summary

Instylla, located in Bedford, MA, seeks a Manufacturing Engineer - Sustaining to drive sustaining engineering activities for embolic product lines and delivery devices. You will manage supplier changes, process validations, and documentation under GMP and DHF/DMR requirements.

The role requires a biomedical/related engineering degree and 2+ years in medical devices, with experience in process validation, DOE, and statistical analysis. Collaboration with QA, R&D, and supply chain is essential.

Qualifications

• Requires a Bachelor's degree in a relevant engineering field and 2+ years of medical device experience.
• Hands-on validation, IQ/OQ/PQ, and DOE/capability studies are preferred.
• Experience with GMP/Documentation practices and process validation is required.

Responsibilities

• Lead sustaining engineering activities for embolic product lines and delivery devices.
• Evaluate changes, perform verifications, and update DHF/DMR under QMS requirements.
• Collaborate cross-functionally with Production, Quality, R&D, Regulatory Affairs, and Supply Chain.

Skills

Process validation

DOE capability studies

Statistical analysis

Communication skills

Multi-tasking

Self-motivation

Education

Bachelor’s degree in Biomedical Engineering

Related engineering discipline

Tools

QAD ERP

Oracle ERP

SAP ERP

SolidWorks

Job description

Instylla, located in Bedford, MA, seeks a Manufacturing Engineer - Sustaining to drive sustaining engineering activities for embolic product lines and delivery devices. You will manage supplier changes, process validations, and documentation under GMP and DHF/DMR requirements.

The role requires a biomedical/related engineering degree and 2+ years in medical devices, with experience in process validation, DOE, and statistical analysis. Collaboration with QA, R&D, and supply chain is essential.