A Senior Manufacturing Engineer is needed for an American medical technology company primarily focused on women's health, selling medical devices for diagnositcs, surgery, and medical imaging, in the Newark, DE area. This role centers on high-level validation (IQ/OQ/PQ), Lean process optimization, and cross-functional leadership to ensure regulatory compliance and product reliability.
location: Newark, Delaware
job type: Contract
salary: $70.00 - 82.50 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Create and execute comprehensive validation plans including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Lead the manufacturing implementation of sustaining design initiatives and product improvements.
- Detect and execute process improvement opportunities using Lean methodologies and tools.
- Distill complex technical data into meaningful summaries for diverse stakeholder groups.
- Lead cross-functional troubleshooting exercises to identify and implement rapid technical solutions.
- Author and revise critical quality documents including process flowcharts, PFMEA, and Process Control plans.
- Facilitate Lean Kaizen events, Value Stream Mapping, 5S, and GEMBA walks.
- Manage the technical interface and relationship with contract manufacturing staff for capital equipment and sterile disposables.
- Collaborate with R&D, Procurement, Quality Assurance, and Regulatory Affairs to mitigate project risks.
- Medical device industry experience.
- Extensive validation experience, including employment of sound statistical approach and authorship of solid protocols and or reports.
- Ability to manage projects and lead and coordinate cross-functional teams.
- Thorough understanding of Lean Manufacturing principles required 5S, Value Stream Mapping, Kanban, SMED, GEMBA mindset, KPI development and management.
- Good understanding of product lifecycle management PLM applications such as AGILE and ERP systems such as ORACLE, SAP or BAAN.
- ORACLE is preferred.
- Experience with LABVIEW highly preferred.
- Experience with computer-aided design software required, Solid works preferred.
- B.S. Engineering preferably in Mechanical, Electro-Mechanical, Electrical, or Industrial Engineering.
- 7 or more years' experience in Manufacturing and or Manufacturing Engineering with working knowledge of electro-mechanical sub-assemblies.
qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
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.
