What are the responsibilities and job description for the Validation Engineer position at MSR Technology Group?
Job Title: Validation Engineer - Manufacturing Operations
Job Location: North Haven, CT (Onsite)
Duration: Long Term.
Ex Medtronic experience is mandatory, manufacturing, validation, and automation
Soft Skills
- Strong ownership mindset with the ability to lead cross-functional teams under regulated constraints.
- Effective communicator with experience presenting technical content to leadership, quality, and regulatory teams.
- Ability to manage multiple priorities, drive structured problem-solving, and implement scalable engineering solutions.
Key Responsibilities
- Oversee and optimize complex production processes for surgical devices, ensuring alignment with efficiency and quality standards.
- Act as the primary technical expert for electro-mechanical equipment issues, identifying root causes and implementing sustainable corrective actions to minimize downtime.
- Lead the development and execution of validation strategies, including Installation, Operational, and Performance Qualifications (IQ/OQ/PQ) for new and existing equipment.
- Apply Lean principles to identify opportunities for waste reduction and process stability.
- Lead non-conformance (NCMR) and Corrective and Preventive Action (CAPA) investigations to uphold strict quality system requirements.
- Support the adaptation of machine or equipment design to factory and production conditions
Required Qualifications
- Bachelor’s degree in electrical engineering, Controls, Automation, Mechatronics, or related field.
- 10 years of relevant manufacturing engineering experience (or 8 years with a master’s degree).
- Mastery of medical device process validation (IQ/OQ/PQ), statistical analysis (Minitab), and high-volume manufacturing assembly.
- Proven ability to troubleshoot complex automated systems including robotics, motion control, and machine vision.
- Strong background in statistical analysis, including process capability, process control, DOE, and inspection design In-depth understanding of Production Part Approval Process (PPAP) for component qualification
Qualification:
- Bachelor’s degree in electrical engineering, Controls, Automation, Mechatronics, or related field.