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.

• 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

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells. ManpowerGroup (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands - Manpower, Experis, Talent Solutions, and Jefferson Wells - creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent. ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.