Manufacturing engg

Title: Manufacturing engg 

Location:  Andover, MA
Duration: 6 months with a long-term contract 

Responsibilities

Lead and support manufacturing engineering activities associated with the production of complex electromechanical medical devices.
Partner closely with production teams to develop, optimize, and sustain robust manufacturing processes.
Drive improvements to existing processes, focusing on efficiency, scalability, and product quality.
Lead the introduction of new products and processes into manufacturing, including selection, qualification, installation, and validation of equipment, tooling, and fixtures.
Own and execute continuous improvement initiatives aimed at reducing cost, improving yield, and enhancing overall operational performance.
Develop and maintain comprehensive manufacturing documentation, including work instructions, inspection procedures, test methods, assembly drawings, and technical specifications.
Collaborate cross-functionally (R&D, Quality, Operations) to identify and implement process, test, and design improvements.
Support investigation and resolution of technical and quality issues, including participation in MRB, CAPA, nonconformance investigations, and customer complaint analysis.
Contribute to design for manufacturability (DFM) and design for assembly (DFA) efforts during product development.
Ensure compliance with applicable regulatory and quality system requirements while maintaining a strong focus on safety and operational excellence.
 

Requirements
Bachelor’s degree in Mechanical, Electrical, Biomedical, or related Engineering discipline.
5–10 years of experience in manufacturing engineering, preferably within a regulated industry such as medical devices, life sciences, or aerospace.
Demonstrated experience supporting both sustaining manufacturing and new product introduction (NPI).
Strong understanding of process development, equipment qualification, and manufacturing best practices.
Experience working within FDA and/or ISO-regulated environments (e.g., ISO 13485) is highly preferred.
 

Nice-to-Have Qualifications
Hands-on experience with process validation (IQ/OQ/PQ) and equipment qualification.
Proficiency with CAD tools such as SolidWorks or Creo for fixture design and manufacturing support.
Familiarity with statistical analysis tools and methodologies (e.g., Minitab, SPC) and Lean/Six Sigma principles.
Proven ability to analyze data, identify root causes, and implement effective corrective actions.
Strong organizational, problem-solving, and project management skills.
Excellent communication skills with the ability to work effectively in cross-functional teams.