#gtthcr
Senior Manufacturing Engineer
Contract duration Six months with possible extension

Summary of Duties and Responsibilities:
Senior Manufacturing Engineer will 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.
Senior Manufacturing Engineer will 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 the completion of duties and communication of relevant information.
Interface with suppliers and Quality Engineering to resolve supplier quality issues.
Senior Manufacturing Engineer will monitor quality reports and field performance of assigned product lines, identify trends, investigate problems, and implement corrective actions.
Actively supports and adheres to the Quality Policy and Quality System procedures.
Other duties relating to the above may be required.
Extensive travel will be required up to 25% during critical times, including extended presence at contract manufacturer Midwestern US.

Qualifications
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 are key to being successful in this role.
Quick learner, driven, and not afraid to experiment.
Ability to manage projects and lead and coordinate cross-functional teams.
A 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 is highly preferred.
Experience with computer-aided design software is required, Solid work is 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.

Physical Demands
A thorough completion of this section is needed for compliance with legal standards such as the Americans with Disabilities Act. The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
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 40 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 Summary:
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.

Note:
Work Site: Onsite at Newark location
Travel Expectation: 25% travel between the Danbury and Newark sites. Travel expenses will be reimbursed.

Benefits:
Medical, Vision, and Dental Insurance Plans
401k Retirement Fund

About The Company:
Our client is an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day. While they develop groundbreaking products and services that benefit everyone, they are especially passionate about those that advance women’s health and well-being. This allows us to be a company that prospers, grows, and empowers women to experience healthier lives.
What powers their growth across Breast and skeletal Health, Diagnostic Solutions, and GYN Surgical Solutions is also what differentiates them: the exceptional and clinically proven ability of their products to detect, diagnose, and treat illnesses and other health conditions earlier and better.
None of this would be possible without the talent, skills, and aspirations of their employees. Their proficiency and commitment to develop and share more robust, science-based certainty drives the company’s increasingly global presence, as well as a pipeline that responds to the unmet health and wellness needs of women, families, and communities.