Job Description: 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. 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.
- Extensive travel will be required up to 70% during critical times, including extended presence at contract manufacturer Midwestern US.
Requirements:
- B.S. Engineering preferably in Mechanical, Electro-Mechanical, Electrical, or Industrial Engineering.
- 7or more years' experience in Manufacturing and or Manufacturing Engineering with working knowledge of electro-mechanical sub-assemblies.
- 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.