Title : Sr. Manufacturing Engineer (Medical Devices)
Location : Danbury CT
Duration : 9 months contract
Pay : $70/hr on W2
Summary of Duties and Responsibilities:
- Support the transfer of our current manufacturing lines in Danbury, CT to our Newark, DE facility.
- This includes both duplication and transfer of manufacturing equipment.
- Create and execute validation plans, including IQ, OQ, and PQs.
- 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.
- Work effectively with other functions such as Procurement, Design Quality Assurance, Regulatory Affairs, and Field Service in completion of duties and communication of relevant information.
- Actively supports and adheres to the Quality Policy and Quality System procedures.
- Other duties relating to above as may be required.
- Travel will be required at times, up to 25%, to our Danbury, CT facility.
- Medical device industry experience.
- Experience with manufacturing line transfers is highly desired.
- 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 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. - Manager flexible on number of years experience. Prefer close to 7 years
- Sit; use hands to finger, handle or feel objects, tools, or controls. Repetitive hand motion.
- Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
- Lifting and or moving and carrying products weighing up to 50 pounds.
- Exposure to moving mechanical parts, vibration and or moderate noise levels.
- Exposure to hazardous chemicals or other materials.
- May work with or around high voltage and radiation generating equipment.
- Safety shoes with impact and compression protection must be worn in designated areas.
Job Type: Contract
Pay: $65.00 - $70.00 per hour
Ability to commute/relocate:
- Danbury, CT 06810: Reliably commute or planning to relocate before starting work (Required)
Work Location: In person
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