Position Title: Senior Manufacturing Engineer
Work Location: Newark, DE, USA, 19702
Assignment Duration: 8 months
Work Schedule: 2nd shift - 3 PM - 11 PM
Work Arrangement: Onsite

---

Position Summary:
The Manufacturing Engineer 3 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.

---

Key Responsibilities:

• 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.

---

Qualification & Experience:

• Medical device industry experience

• Extensive validation experience, including employment of sound statistical approach and authorship of solid protocols and or reports.

• Advanced inter-personal 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. ORACLE is preferred.

• Experience with LABVIEW highly preferred.

• Experience with computer-aided design software required, Solid works preferred.

Education:
B.S. Engineering preferably in Mechanical, Electro-Mechanical, Electrical, or Industrial Engineering

Experience:
7 or more years’ experience in Manufacturing and or Manufacturing Engineering with working knowledge of electro-mechanical sub-assemblies.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 75.00/daily.