Manufacturing Engineer – Medical Device / ISO 13485
Position Summary
We are seeking a Manufacturing Engineer with experience in medical device manufacturing and ISO 13485 compliance to support products from development through commercialization. This individual will play a key role in ensuring manufacturing processes, documentation, and validation activities meet regulatory, quality, and customer requirements throughout the product lifecycle.
Key Responsibilities
- Lead New Product Introduction (NPI) activities from concept through production and customer delivery.
- Develop, validate, and improve manufacturing processes in compliance with ISO 13485 and FDA medical device requirements.
- Execute and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for manufacturing equipment and processes.
- Partner closely with Quality and Regulatory Affairs to ensure all products, processes, and documentation meet applicable compliance standards.
- Author and maintain validation protocols, reports, SOPs, work instructions, manufacturing process documentation, and engineering change documentation.
- Drive Lean Manufacturing, Six Sigma, and continuous improvement initiatives focused on quality, efficiency, yield improvement, and waste reduction.
- Support audits, CAPA activities, root cause investigations, and supplier quality initiatives.
- Ensure manufacturing processes are scalable, repeatable, and compliant with customer and regulatory expectations.
Qualifications
- Bachelor's degree in Engineering or related technical field.
- 3+ years of Manufacturing Engineering experience within a medical device or regulated manufacturing environment.
- Strong knowledge of ISO 13485 and FDA-regulated manufacturing environments.
- Hands-on experience with IQ/OQ/PQ validation and process qualification activities.
- Experience supporting products through the full NPI lifecycle from development to production.
- Strong documentation skills with experience authoring validation and quality system documentation.
- Lean Manufacturing and Six Sigma experience required; Green Belt preferred.
- Excellent collaboration skills with Engineering, Quality, Regulatory Affairs, and Operations teams.
This is an excellent opportunity for an engineer who enjoys building compliant manufacturing processes, driving product launches, and helping establish best practices within a growing medical device environment.