job summary

Looking for a Senior Manufacturing Engineer in Newark, DE. Join Our Client, a global force innovating women's health technology! We seek a driven engineer with a BS, 7+ years manufacturing experience, medical device background, and Lean expertise to lead critical improvements and raise the standard of care.

location: Newark, Delaware

job type: Contract

salary: $50 - 70 per hour

work hours: 8am to 5pm

education: Bachelors

responsibilities

• Develop and execute comprehensive validation plans (IQ/OQ/PQ) and critical process documents (PFMEA, Control Plans) to support capital equipment and high-volume sterile disposables.
• Spearhead process improvements and facilitate Lean Kaizens utilizing methodologies like 5S, Value Stream Mapping, and SMED to optimize Our Client's operations.
• Serve as the primary technical liaison between Our Client and critical contract manufacturers, effectively mitigating risks, ensuring compliance, and resolving supplier quality issues.
• Direct cross-functional projects across R&D, Quality Assurance, and Regulatory Affairs, distilling complex technical challenges into clear, actionable summaries for all stakeholders.
• Monitor field performance and quality reports for assigned product lines, lead troubleshooting initiatives, and implement swift corrective actions while adhering to Our Client's strict Quality Systems.

qualifications

• Experience level: Experienced
• Education: Bachelors

skills

• Manufacturing
• Medical Device
• Pharmaceutical
• Lean

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.