Manufacturing Engineer

Job Description

Manufacturing Engineer 4

Marlborough, MA - Onsite

6+ Months possible extension

Day to Day Responsibilities:

The Senior Manufacturing Engineer will lead the modernization of legacy manufacturing processes and production documentation. The role focuses on implementing manufacturing controls derived from ISO 14971 risk management outputs and product specifications.

• Develop, update, and revise manufacturing work instructions, assembly procedures, drawings, and equipment documentation, including remediation-driven changes.
• Review DHFs and Risk Management Reports to identify CTQs requiring manufacturing controls.
• Develop and maintain PFMEAs, including process inputs, potential failure modes, and operational risks.
• Develop and implement Control Plans derived from PFMEAs, including monitoring methods and reaction plans.
• Support definition, development, and validation of manufacturing processes, assembly methods, and test methods.
• Create and execute Test Method Validation and Computer System Validation activities; improve validated inspection methods.
• Support execution of Process Validation (IQ/OQ/PQ) for manufacturing equipment and processes.
• Evaluate automated production equipment used in high‑volume bottling, filling, capping, and chemical mixing processes.
• Collaborate with Quality and Validation Engineering to ensure processes maintain a validated state during routine production.
• Participate in design reviews and provide input to ensure final manufacturability of the product.
• Lead root cause analysis and recommend corrective and preventive actions for manufacturing remediation issues.
• Ensure compliance with all company policies and procedures, including safety regulations, Personal Protective Equipment (PPE) requirements, Standard Operating Procedures (SOPs), Quality Management System regulation (QMSR), ISO standards, and Good Documentation Practices (GDP).
• Engage in continuous improvement initiatives, striving for operational excellence and efficiency.

Required Skills:

Education

• Bachelor’s degree or Master’s degree in Mechanical, Industrial, Manufacturing, Biomedical, or Electrical Engineering.
• 10+ years of manufacturing engineering experience in regulated manufacturing environments.
• Experience with Process Validation (IQ/OQ/PQ) and Test Method Validation (TMV).
• Strong working knowledge of risk management and process validation, including TMV.
• Comprehensive knowledge of manufacturing methods / processes, procedures and cost-reduction techniques (i.e. DFM, Lean, VAVE, Six Sigma, etc.).
• Ability to troubleshoot complex Electromechanical, Pneumatic and Software systems.
• Excellent working knowledge of medical device regulations 21 CFR, ISO 13485, ISO 14971, IVDR, and other applicable standards.
• Knowledge of IPC standards (electrical) and ANSI, GDT (mechanical).
• Ability to use problem-solving tools (SPC, TQM, etc.) to optimize processes.
• Ability to analyze a situation or data; evaluate relevant identifiable factors and translate this information into a meaningful proposal or action plan.
• Ability to develop and carry out corrective action plan interfacing with multiple groups when required.
• Ability to effectively communicate ideas and approaches in the form of proposals, plans and presentations.