Job Description

Position: - Manufacturing and Testing Specialist

Location: - North Haven, CT

Job Description

• We are seeking a highly skilled and motivated Manufacturing and Testing Specialist with experience in the medical devices or hi-tech mechanical/electromechanical product manufacturing industry. The ideal candidate will be responsible for a range of manufacturing and testing activities, ensuring high-quality standards and compliance with industry regulations.

Key Responsibilities:

• Perform manufacturing, assembly, functional testing, and inspection of parts, sub-assemblies, and final assemblies.
• Develop, execute, and review protocols related to URS (User Requirements Specification), Design Qualification, FAT (Factory Acceptance Testing), SAT (Site Acceptance Testing), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
• Generate protocol reports, review and ensure proper approval processes are followed.
• Ensure compliance with ISO 13485, 21CFR Part 820 regulations (training will be provided if needed).
• Demonstrate hands-on experience with automation equipment to ensure the efficient production process.
• Work with vision systems, robots, and inspection systems (preferred but not required).

Qualifications:

• Proven experience in manufacturing, assembly, functional testing, and inspection within the medical devices or high-tech mechanical/electromechanical industry.
• Expertise in URS, Design Qualification, FAT, SAT, IQ, OQ, PQ processes.
• Familiarity with ISO 13485 and 21CFR Part 820 (preferred, but not mandatory for candidates with strong industry experience).
• Hands-on experience with automation equipment is required.
• Experience working with vision systems, robots, and inspection systems is a plus.
• Ability to work 100% onsite, with no remote or hybrid options available.

Preferred Experience:

• Strong experience in the medical device industry or equivalent high-tech mechanical/electromechanical product manufacturing environment.
• Ability to develop and execute protocols on the floor and generate, review, and approve protocol reports.

If you meet the qualifications and are excited to join our team, we encourage you to apply. We offer a dynamic work environment and the opportunity to contribute to cutting-edge projects in the medical device manufacturing industry.

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