Foundry Engineer – Casting Process (Medical Device Implants)

Stark Pharma Solutions Inc; Raynham (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Stark Pharma Solutions Inc. is recruiting a Foundry Engineer for a medical device implants project based in Raynham, MA. The role focuses on supporting metal casting operations, tooling, process validation and statistical analysis in a floor-facing environment.

The candidate will perform IQ/OQ/PQ validation, GD&T, CMM inspections and collaborate with Quality, Maintenance, and Operations to improve yield and process capability. Onsite work is required; U.S. work authorization is needed.

Qualifications

• Hands-on foundry experience is required.
• Experience with IQ/OQ/PQ validation protocols.
• Strong knowledge of GD&T, CMM and gaging.
• Experience with metals, casting, brazing and wax injection.
• Medical device or regulated manufacturing experience preferred.
• NX CAD and Windchill experience preferred.
• Must be onsite in Raynham, MA and eligible to work in the United States.

Responsibilities

• Provide day-to-day manufacturing engineering support to foundry and casting operations.
• Support investment casting processes including wax injection, shell building, pouring, brazing and finishing.
• Troubleshoot casting defects and drive yield, scrap and process capability improvements.
• Author and execute IQ/OQ/PQ protocols for casting equipment and processes.
• Support tooling, fixture and gage activities including design input, first article inspection and vendor coordination.
• Perform and interpret dimensional inspection using CMM and GD&T.
• Conduct statistical analysis using Minitab to support process characterization and validation.
• Partner with Quality, Maintenance and Operations on corrective actions, change control and documentation.
• Maintain manufacturing procedures, work instructions and equipment records.

Skills

Hands-on foundry experience

Statistical analysis

Process validation

GD&T

CMM inspection

Education

Bachelor's degree in Mechanical Engineering or related

Tools

NX CAD

Windchill

Minitab

CMM

Fixture & Gage Design

Job description

About Company

Stark Pharma Solutions Inc is a life sciences staffing and consulting firm supporting pharmaceutical, biotechnology and medical device organizations across the United States. We place quality, validation, manufacturing and regulatory professionals with companies building and scaling FDA-regulated operations. Our clients range from established manufacturers to early-stage sites standing up their first quality systems.

Foundry Engineer Casting Process (Medical Device Implants)

Job Summary

Our client, a medical device manufacturer in southeastern Massachusetts, is seeking a Foundry Engineer with hands-on foundry experience to support metal casting operations. This is a floor-facing role covering casting process support, tooling and gage activities, process validation and statistical analysis. Hands-on foundry experience is a mandatory requirement for this position.

Responsibilities

• Provide day-to-day manufacturing engineering support to foundry and casting operations
• Support investment casting processes including wax injection, shell building, pouring, brazing and finishing
• Troubleshoot casting defects and drive yield, scrap and process capability improvements
• Author and execute process validation protocols (IQ/OQ/PQ) for casting equipment and processes
• Support tooling, fixture and gage activities including design input, first article inspection and vendor coordination
• Perform and interpret dimensional inspection using CMM and standard gaging methods; apply GD&T
• Conduct statistical analysis using Minitab to support process characterization and validation
• Partner with Quality, Maintenance and Operations on corrective actions, change control and documentation
• Maintain manufacturing procedures, work instructions and equipment records

Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Metallurgy, Materials Science or a related technical discipline
• Minimum 3 years of Mechanical or Manufacturing Engineering experience, with hands-on foundry experience required
• Working knowledge of metals, casting, brazing and wax injection
• Experience authoring and executing process validation protocols
• Strong working knowledge of GD&T, CMM and gaging
• Statistical analysis experience, ideally Minitab
• Medical device or other regulated manufacturing experience preferred
• NX CAD and Windchill experience preferred
• Fixture and gage design, and wax injection tooling experience, are strong advantages
• Must be able to work 100% onsite in Raynham, Massachusetts
• Must be authorized to work in the United States without sponsorship, now or in the future
• W2 employment only