Job Title: Manufacturing Engineer
Client: Direct
Location: Cambridge, MA (02139)-Onsite
Employment Type: Contract to Hire (Will convert to Full Time)
Target Pay Rate: $55/hr
Work Schedule: 7 Hours/Shift
Role OverviewWe are seeking a hands-on
Manufacturing Engineer to evaluate, optimize, and document in-process and incoming testing jigs, ensuring precise accuracy and repeatability for novel medical device manufacturing. This role is responsible for executing test method validations, supporting equipment qualifications (IQ/OQ/PQ) at contract manufacturing sites, and driving seamless design transfer to contract manufacturers within a regulated GMP environment.
Key Responsibilities- Testing & Jigs Optimization: Evaluate, operate, and document mechanical testing fixtures/jigs; conduct Gage R&R studies to verify measurement accuracy and repeatability.
- Validation & Transfer: Execute Test Method Development (TMD) and Test Method Validation (TMV); support IQ/OQ/PQ activities and design transfer to contract manufacturing facilities.
- Prototyping & Materials: Execute testing on disposable catheter and camera prototypes; manage supply chain logistics, inventory flow, and BOM structures for R&D/manufacturing components.
- Quality & DFM Alignment: Review engineering drawings to ensure Design for Manufacturability (DFM) compliance; manage ECRs, process documentation, and evaluation reports in a QMS using FMEA principles.
- Cross-Functional Collaboration: Partner with Engineering and Quality teams to capture design outputs and ensure strict adherence to GMP standards.
Qualifications & Core Competencies- Experience: 2-5 years in medical device manufacturing or R&D engineering within regulated GMP environments.
- Technical Skills: Hands-on experience with mechanical testing jigs/fixtures, Gage R&R studies, and disposable manufacturing processes.
- Materials & Design: Working knowledge of injection molding, polymers, catheter/camera assembly, metal processing, and medical device mechanical design.
- Tools & Systems: Proficiency in SolidWorks CAD, BOM management, ECR execution, and Quality Management Systems (QMS).
- Logistics & Quality: Proven track record in lab inventory management, vendor coordination, FMEA, and IQ/OQ/PQ execution.
Ideal Candidate Profile- Current Title: Manufacturing Engineer / R&D Engineer
- Core Strengths: Strong technical/hands-on orientation, GMP compliance, fixture testing, TMV execution, and contract manufacturing design transfer.
- Target Salary (for C2H/Direct Conversion): $100K - $115K
- Commute Tolerance: Up to 45-60 minutes to Cambridge, MA.
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