Engineer

Lancesoft

Gary, IN

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JOB DETAILS

SALARY

$35

SKILLS

Analysis Skills, Assembly Line, Automation, Best Practices, Budget Management, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Design Services, Documentation, Editing, Establish Priorities, FDA (Food and Drug Administration), FDA Requirements, GEP (Good Engineering Practices), Laboratory Equipment, Laboratory Techniques, Leadership, Maintain Compliance, Manufacturing, Manufacturing Systems, Manufacturing/Industrial Processes, Medical Equipment, Performance Management, Plastic Injection Molding, Process Capability, Process Control Engineering, Process Development, Process Improvement, Process Validation, Production Support, Project/Program Management, Quality Assurance Methodology, Quality Engineering, Quality Management, Quality System Requirements (QSR), Receivers, Root Cause Analysis, SolidWorks, Staff Training, Support Documentation, Technical Writing, Testing, Time Management, United States Department of Energy (DOE)

LOCATION

Gary, IN

POSTED

15 days ago

Top requirement:
Role Highlights
Engineer II role supporting FDA-regulated medical device manufacturing.
Position will focus on manufacturing and process support, including validation activities.
Bachelor s degree in Engineering required;target experience range of 2 4 years +.
Validation experience (IQ/OQ/PQ) strongly preferred.
Interview & Location Notes
In-person interviews preferred where feasible.
Role is onsite with a temporary split between Gary, IN and Highland, IN during facility transition.
Permanent work location expected to be Highland, IN following relocation completion.
Key Takeaways
Prioritizing candidates with regulated manufacturing experience.
Hiring timeline is accelerated due to business need.
Strong performers may be considered for longer-term opportunities.

The Engineer II, Manufacturing is responsible for supporting manufacturing process improvements through adherence to established design control processes, good engineering and documentation practices. The key responsibility of this position is to support and sustain production. The Engineer II will complete intermediate projects with guidance from more experienced engineers and managers. They gain exposure to some of the complex tasks within the job function and are occasionally directed in several aspects of the work.

Quals--
Essential Duties & Responsibilities
Immediate expectations:
o Under the guidance of the Engineering leadership, work to improve performance of manufacturing systems, e.G. OEE improvement (quality, performance and uptime), maintenance needs, MUV and scrap reduction
o Support project timelines and milestones and bring them to completion on time and within budget
o Assist in completion of CAPA tasks and deliverables (Corrective and Preventive)
o Use methodical approach for root cause analysis and propose robust technical solutions
o Process technical expert for a manufacturing production line
o Create and edit documents to support Production
o Support initiatives for continuous process and product improvements
o Conducts independent analysis and develops solutions to problems.
o Develops approaches and designs where precedent usually exists.
o Performs developmental and/or test work that relies heavily on a comprehensive knowledge of theory and design
o Receives general project direction. Solicits input from more experienced engineers.
o Work on special projects as they arise
Long term expectations:
o Initiate and manage projects with adherence to program-management guidelines
o Develop innovative tool design improvements
o Develop and characterize processes and summarize technical details
o Work with Quality Engineers on qualification activities for new or modified processes and equipment.
o Assists in training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures.
o Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.

Knowledge & Skills
General understanding of automation, plastic injection molding, part assembly, fixturing, testing, and process control techniques
Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.)
Knowledge of the Medical Device Industry and familiarity with FDA QSR Regulations - preferred
Proficiency in SolidWorks. Mechanical understanding, tool design experience
Technical writing competency
Competent in your domain. Familiar with other areas of domain expertise within the team.
Has a basic understanding of best practices. Has a basic to intermediate understanding of engineering discipline
Have awareness of the broader product strategy and contribute to it
Ability to receive general project direction and solicit input from more experienced engineers.
Requires the ability to independently make decisions that impact the attainment of project objectives.

Minimum Qualifications, Education & Experience
Must be at least 18 years of age
Bachelor s degree from an accredited college or university (Engineering, Technology, or STEM)

About the Company

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

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