Senior Manufacturing Engineer

Location: Newark, DE

Onsite Flexibility: Onsite

• Position Type: Contract
• Contract Duration: 8 Months(extension possible)
• Pay Rate: $70.00 $ 75.00 / Hour (USD)
• Shift / Schedule: First Shift, 6:00 AM 2:30 PM
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

The Senior Manufacturing Engineer provides a key technical interface to a critical contract manufacturing relationship. The contract manufacturer provides a system consisting of electromechanical capital equipment as well as high-volume sterile disposables. These are hands-on manufacturing engineering roles focused heavily on supporting the production floor. The engineers will respond immediately when issues arise, troubleshoot processes, and provide on-the-spot support. Strong floor presence is required.

Candidates must have both manufacturing engineering experience and medical device exposure; no automotive-only or generic manufacturing backgrounds.

• Create and execute validation plans, including IQ of process equipment and OQ and/or PQ of manufacturing processes.
• Lead manufacturing implementation of sustaining design initiatives.
• Detect, conceptualize, and execute improvement opportunities using a series of Lean and related tools and methodologies.
• Distill complex technical situations into meaningful summaries that are digestible by various stakeholders.
• Lead troubleshooting exercises to quickly get to solutions.
• Create and revise essential documents such as process flowcharts, PFMEA, and Process Control plans.
• Practice LEAN techniques and be able to facilitate lean kaizens.
• Interface with contract manufacturing staff and management to ensure that plans are followed and risks are mitigated.
• Work effectively with other functions such as research and development, Procurement, Design Quality Assurance, Regulatory Affairs, and Field Service in completion of duties and communication of relevant information.
• Interface with suppliers and Quality Engineering to resolve supplier quality issues.
• Monitor quality reports and field performance of assigned product line, identify trends, investigate problems, and implement corrective actions.
• Actively supports and adheres to the Quality Policy and Quality System procedures.
• Other duties relating to above as may be required.

Core Responsibilities

• Floor-based troubleshooting and issue resolution
• Support for validated processes (understanding of validation required)
• Root cause analysis and corrective actions
• Hands-on support across manufacturing and quality teams
• Rapid response (firefighting mode) when issues occur
• Compliance with med device documentation and regulatory expectations

• Medical device industry experience
• Extensive validation experience, including employment of sound statistical approach and authorship of solid protocols and/or reports
• Advanced interpersonal skills; communication and emotional awareness is key to be successful in this role
• Quick learner, driven and not afraid to experiment
• 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
• Experience with computer-aided design software required
• Manufacturing engineering background
• Minimum 2 3 years of medical device experience
• Strong, hands-on presence on the floor
• Troubleshooting mindset and ability to respond to issues immediately
• Knowledge of validation concepts (even though most work involves troubleshooting existing validated processes)
• Must be comfortable wearing safety shoes daily and being physically present on the floor most of the time

• ORACLE preferred for PLM/ERP systems
• Experience with LABVIEW highly preferred
• Solid Works preferred for computer-aided design software

• B.S. in Engineering, preferably in Mechanical,…