Senior Systems Engineer

• Review and approve engineering drawings, process validation protocols, SOPs, control plans, and reports to ensure compliance with industry standards.
• Lead process control and monitoring of Critical to Quality (CTQ) parameters, implementing methodologies such as Six Sigma and Lean Manufacturing for continuous improvement.
• Support validation projects for existing products, new processes, and equipment, ensuring adherence to FDA, GMP, ISO 13485, and ISO 14971 standards.
• Collaborate on risk management activities, including remediation of Process FMEA (PFMEA), updating Design FMEAs, and conducting hazard analyses to meet global regulatory requirements.
• Develop and execute system-level test strategies, supervise CAPA activities, and document evidence for regulatory submissions such as FDA and CE technical files.

Our client, a leader in the medical device industry, is seeking a Senior Systems Engineer to join their team. As a Senior Systems Engineer, you will be part of the Engineering Department supporting product development, validation, and regulatory compliance. The ideal candidate will demonstrate strong analytical skills, attention to detail, and a proactive approach to problem-solving, which will align successfully in the organization., * Extensive experience with design validation, process validation, and equipment validation in a regulated environment.

• Strong knowledge of regulatory standards including FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• Proficiency in risk management tools such as DFMEA, PFMEA, and hazard analysis.
• Experience with system-level testing, verification protocols, and validation documentation.
• Excellent collaboration skills to work effectively across cross-functional teams and external partners.

What’s in it for me?

• Opportunity to contribute to innovative medical device solutions that impact patient care.
• Engagement in a dynamic and supportive work environment focused on continuous improvement.
• Chance to develop your expertise within a globally recognized organization.
• Work on projects that meet rigorous regulatory standards, enhancing your professional credentials.
• Be part of a team committed to quality, compliance, and technological advancement.

Upon completion of waiting period consultants are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay