Job Description

Job Title: Manufacturing Engineer Andover, MA

We are seeking a skilled Manufacturing Engineer to support the production of complex electromechanical medical devices. Local or nearby candidates are preferred.

Responsibilities:

• Lead and support manufacturing engineering activities for electromechanical device production
• Develop, optimize, and sustain robust manufacturing processes with production teams
• Drive process improvements for efficiency, scalability, and product quality
• Support new product introduction (NPI), including equipment/tooling selection, qualification, and validation
• Lead continuous improvement initiatives to improve yield and reduce costs
• Create and maintain manufacturing documentation (work instructions, inspection methods, technical specs)
• Collaborate with R&D, Quality, and Operations for process and design improvements
• Support MRB, CAPA, nonconformance investigations, and customer complaint analysis
• Contribute to DFM/DFA during product development
• Ensure compliance with FDA/ISO standards and safety requirements

Requirements:

• Bachelor's degree in Mechanical, Electrical, Biomedical, or related Engineering field
• 5 10 years of manufacturing engineering experience in regulated industries (medical device preferred)
• Experience in both sustaining manufacturing and NPI activities
• Strong knowledge of process development and equipment qualification
• Familiarity with FDA and/or ISO 13485 standards

Nice-to-Have:

• Experience with IQ/OQ/PQ and equipment qualification
• Proficiency in SolidWorks or Creo
• Knowledge of Minitab, SPC, and Lean/Six Sigma
• Strong problem-solving, analytical, and project management skills

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